1 |
NCT00908076 |
Completed Has Results |
Amitiza in Constipation Associated With PD (Parkinson's Disease) |
|
|
Interventional |
Phase 4 |
- Baylor College of Medicine
- University of South Florida
- Baylor College of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline to End of Study
|
78 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT00908076 |
H-21192 |
AMITIZA |
February 2009 |
October 2010 |
October 2010 |
May 25, 2009 |
March 16, 2018 |
August 26, 2016 |
- University of South Florida
Tampa, Florida, United States - Baylor College of Medicine PDCMDC
Houston, Texas, United States
|
2 |
NCT01883973 |
Unknown † |
MER Versus MRI Guidance DBS in Parkinson's Disease |
- Idiopathic Parkinson's Disease (PD)
|
|
Observational |
|
- Baylor College of Medicine
- Baylor College of Medicine
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- percentage improvement in the UPDRS part III motor score
|
20 |
All |
30 Years to 79 Years (Adult, Senior) |
NCT01883973 |
H-27630 |
|
May 2011 |
December 2014 |
|
June 21, 2013 |
June 21, 2013 |
|
- Baylor College of Medicine
Houston, Texas, United States
|
3 |
NCT00641186 |
Completed |
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) |
|
|
Interventional |
Not Applicable |
- Baylor College of Medicine
- Jazz Pharmaceuticals
- Baylor College of Medicine
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability of Xyrem (sodium oxybate) oral solution at nightly doses of 4.5 to 9.0 grams in patients with Parkinson's Disease
- To evaluate the possible efficacy of Xyrem in the treatment of the sleep disturbances and EDS common in Parkinsonian patients.
- To determine if Xyrem treatment improves daytime motor symptoms and the overall quality of life in patients with mild to moderate PD.
|
30 |
All |
30 Years to 75 Years (Adult, Senior) |
NCT00641186 |
H-16378 |
Xyrem |
September 2004 |
July 2008 |
November 2008 |
March 24, 2008 |
May 1, 2009 |
|
|
4 |
NCT00646204 |
Completed |
Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease |
|
- Drug: Memantine
- Drug: placebo
|
Interventional |
Phase 4 |
- Baylor College of Medicine
- Forest Laboratories
- Baylor College of Medicine
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- This is an exploratory study. The primary efficacy point will be global impressions.
- Analyses will be computed for the categorical dependent variables (DV): spirograph, pouring, subjective ADL, observed tremor, global assessment by examiner, global assessment by patient, and subjective assessment by patient scores.
|
40 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00646204 |
H-18912 |
|
April 2006 |
February 2009 |
March 2009 |
March 28, 2008 |
May 1, 2009 |
|
- PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States
|
5 |
NCT00640952 |
Withdrawn |
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease |
|
|
Interventional |
Not Applicable |
- Baylor College of Medicine
- National Parkinson Foundation
- Baylor College of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- safety and efficacy compared to baseline scores
- change from baseline assessment tools used in the study
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT00640952 |
H-19781 |
|
August 2006 |
September 2008 |
September 2008 |
March 21, 2008 |
November 13, 2015 |
|
- PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States
|
6 |
NCT00640159 |
Completed |
Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease |
|
|
Interventional |
Phase 4 |
- Baylor College of Medicine
- Baylor College of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary efficacy point is number of subjects who prefer Zydis selegiline vs. the number who prefer oral selegiline, or have no preference. Descriptive statistics will be used to present the percentages of persons and adverse event resolutions.
- The secondary endpoints will include changes in the UPDRS, PDQ-8, BDI, FSS, ESS, ratings of global improvement and change in dyskinesia.
|
55 |
All |
30 Years to 90 Years (Adult, Senior) |
NCT00640159 |
H-20709 |
|
January 2007 |
June 2008 |
August 2008 |
March 21, 2008 |
March 16, 2009 |
|
- Dee Silver, MD at Coastal Neurological Medical Group, Inc
La Jolla, California, United States - James Tetrud, MD at The Parkinson's Institute
Sunnyvale, California, United States - Stuart Isaacson, MD at Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States - (and 2 more...)
|
7 |
NCT00590122 |
Completed |
Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study |
|
- Drug: Parcopa
- Drug: carbidopa-levodopa
|
Interventional |
Phase 4 |
- Baylor College of Medicine
- UCB Pharma
- Baylor College of Medicine
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
20 |
All |
31 Years to 80 Years (Adult, Senior) |
NCT00590122 |
H-19596 |
|
October 2006 |
October 2008 |
November 2008 |
January 10, 2008 |
March 16, 2009 |
|
- PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States
|
8 |
NCT01337453 |
Completed |
Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy |
|
|
Observational |
|
- Christine Hunter
- Merz North America, Inc.
- Baylor College of Medicine
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The frequency of FLS will be estimated by number of patients and number of Botox treatments
|
247 |
All |
18 Years and older (Adult, Senior) |
NCT01337453 |
H-27678 |
|
April 2011 |
June 2012 |
July 2012 |
April 19, 2011 |
August 24, 2012 |
|
- Baylor College of Medicine, Dept. of Neurology
Houston, Texas, United States
|
9 |
NCT02474459 |
Recruiting |
Mobile Decision Support System for Nurse Management of Neuromodulation Therapy |
|
- Device: iPad-Based Clinical Support Care
- Other: Standard Clinical Care
|
Interventional |
Not Applicable |
- University of Utah
- University of Florida
- National Institute of Nursing Research (NINR)
- (and 2 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Decrease in deep brain stimulation (DBS) programming time compared to standard care when the DBS programming nurse uses an iPad based decision support system
- Decrease in caregiver strain for DBS patients using the iPad-based clinical decision support tool
- Improved outcomes for patients in the intervention groups compared to standard care as measured using the Unified Parkinson's Disease Rating Scale (UPDRS)
|
160 |
All |
30 Years to 75 Years (Adult, Senior) |
NCT02474459 |
IRB # 78062 R01NR014852 |
|
July 2015 |
December 2019 |
December 2020 |
June 17, 2015 |
April 11, 2017 |
|
- University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, United States - Wake Forest School of Medicine
Winston-Salem, North Carolina, United States - Baylor College of Medicine
Houston, Texas, United States - University of Utah Imaging and Neurosciences Center
Salt Lake City, Utah, United States
|
10 |
NCT01798407 |
Recruiting |
DBS of the Lateral Habenula in Treatment-Resistant Depression |
- Treatment Resistant Major Depressive Disorder
|
- Device: Activa Tremor Control Sys (DBS Implant)
- Other: Randomized, staggered withdrawal phase
|
Interventional |
Not Applicable |
- Wayne Goodman MD
- Baylor College of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in HDRS^17 score from baseline to 6 months after the commencement of stimulation
- MADRS (Montgomery and Asberg Depression Rating Scale)
- Clinical Global Impression of Severity (CGI-S)
- (and 8 more...)
|
6 |
All |
21 Years to 70 Years (Adult, Senior) |
NCT01798407 |
H40307 49593 277909 HSM#12-00467 GCO 12-1815 |
|
February 2013 |
August 2019 |
February 2020 |
February 25, 2013 |
December 21, 2017 |
|
- Baylor College of Medicine
Houston, Texas, United States
|
11 |
NCT00203034 |
Completed |
Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations |
|
- Drug: rasagiline mesylate
- Drug: 1.0 mg rasagiline mesylate
- Other: Placebo
|
Interventional |
Phase 3 |
- Teva Pharmaceutical Industries
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in the mean total daily "OFF" time
|
472 |
All |
30 Years and older (Adult, Senior) |
NCT00203034 |
TV-1012/133 |
|
May 2000 |
January 2003 |
January 2003 |
September 20, 2005 |
March 9, 2010 |
|
- Rush - Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States - Columbia - Presbyterian Medical Center
New York, New York, United States - University of Rochester
Rochester, New York, United States - Baylor College of Medicine
Houston, Texas, United States
|
12 |
NCT03170063 |
Recruiting |
FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort) |
|
- Procedure: Procedure/Surgery: Biofluid samplings
|
Observational |
|
- Michael J. Fox Foundation for Parkinson's Research
- University Health Network, Toronto
- Indiana University
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Oligomeric and PS129 α-syn levels
- Time from IRB submission to approval by central IRB
- Time from central IRB approval to site approval (for those sites requiring administrative review)
- (and 4 more...)
|
50 |
All |
30 Years and older (Adult, Senior) |
NCT03170063 |
SAVE001 |
SAVE001 |
August 8, 2017 |
March 31, 2018 |
March 31, 2018 |
May 30, 2017 |
March 29, 2018 |
|
- Rush University Medical Center
Chicago, Illinois, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Oregon Health and Sciences University
Portland, Oregon, United States - (and 2 more...)
|
13 |
NCT02642393 |
Active, not recruiting |
Study of Urate Elevation in Parkinson's Disease, Phase 3 |
|
- Drug: Inosine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Michael Alan Schwarzschild
- The Parkinson Study Group
- Michael J. Fox Foundation for Parkinson's Research
- (and 3 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Rate of clinical decline
- Rate of developing adverse effects
- Proportion developing adverse effects
- (and 9 more...)
|
270 |
All |
30 Years and older (Adult, Senior) |
NCT02642393 |
INO-PD-P3-2014 1U01NS090259-01A1 |
SURE-PD3 |
June 2016 |
March 2020 |
August 2020 |
December 30, 2015 |
January 9, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Barrow Neurological Institute
Phoenix, Arizona, United States - Mayo Clinic Arizona
Scottsdale, Arizona, United States - (and 57 more...)
|
14 |
NCT02819011 |
Recruiting |
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO |
- Accidental Falls
- Fall Due to Loss of Equilibrium
- High Risk of Falls Due to Mobility Limitation
- (and 6 more...)
|
- Device: AFO
- Other: Control
|
Interventional |
Phase 2 |
- Bijan Najafi
- Orthotic Holdings, Inc.
- Baylor College of Medicine
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Gait speed change from baseline to 1 month, 3 months, 6 months
- Balance change from baseline to 1 month, 3 months, 6 months
- Adherence
|
40 |
All |
65 Years and older (Adult, Senior) |
NCT02819011 |
H-38050 |
|
May 2016 |
May 2018 |
December 15, 2018 |
June 30, 2016 |
July 13, 2017 |
|
- Baylor College of Medicine
Houston, Texas, United States
|
15 |
NCT03100149 |
Recruiting |
A Study to Evaluate the Efficacy of RO7046015 in Participants With Early Parkinson's Disease |
|
- Drug: RO7046015
- Drug: Placebo
|
Interventional |
Phase 2 |
- Hoffmann-La Roche
- Prothena Biosciences Limited
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52
- Change From Baseline in Dopamine Transporter Imaging With Single Photon Emission Computed Tomography (DaT-SPECT) Signal at Week 52
- Change From Baseline in the MDS-UPDRS Motor Subscale (Part III) Score
- (and 10 more...)
|
300 |
All |
40 Years to 80 Years (Adult, Senior) |
NCT03100149 |
BP39529 2017-000087-15 |
PASADENA |
June 27, 2017 |
March 31, 2020 |
June 29, 2021 |
April 4, 2017 |
April 5, 2018 |
|
- Uab Medicine
Birmingham, Alabama, United States - Barrow Neurology Clinics; Movement Disorders Program
Phoenix, Arizona, United States - USC Keck Medical Center of USC
Los Angeles, California, United States - (and 53 more...)
|
16 |
NCT02847650 |
Terminated |
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease |
|
- Drug: Placebo
- Drug: PF-06649751
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in the Modified Unified Parkinson's Disease Rating Scale (MDS UPDRS) Score Part III
- Columbia Suicide Severity Rating Scale (C SSRS)
- • Questionnaire for Impulsive Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP RS)
|
57 |
All |
45 Years to 80 Years (Adult, Senior) |
NCT02847650 |
B7601011 2016-001575-71 |
|
October 17, 2016 |
January 29, 2018 |
January 29, 2018 |
July 28, 2016 |
March 5, 2018 |
|
- St Joseph's Hospital and Medical Center, Barrow Neurology Clinics
Phoenix, Arizona, United States - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States - (and 34 more...)
|
17 |
NCT02038959 |
Completed Has Results |
Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes |
|
|
Interventional |
Not Applicable |
- University of Rochester
- Patient-Centered Outcomes Research Institute
- National Parkinson Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Feasibility of Virtual Visits for Parkinson Disease
- Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39
- Change in EQ-5D Index Value
- (and 8 more...)
|
210 |
All |
30 Years and older (Adult, Senior) |
NCT02038959 |
AD-12-11-4701 |
|
March 2014 |
August 2016 |
August 2016 |
January 17, 2014 |
January 27, 2017 |
January 27, 2017 |
- University of California San Francisco
San Francisco, California, United States - The Parkinson's Institute and Clinical Center
Sunnyvale, California, United States - University of Florida
Gainsville, Florida, United States - (and 17 more...)
|
18 |
NCT02258152 |
Completed |
SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) |
- Parkinson's Disease Dementia (PDD)
|
- Drug: SYN120
- Drug: Placebo
|
Interventional |
Phase 2 |
- Biotie Therapies Inc.
- Michael J. Fox Foundation for Parkinson's Research
- Massachusetts General Hospital
- Acorda Therapeutics
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention from baseline
|
80 |
All |
50 Years and older (Adult, Senior) |
NCT02258152 |
SYN120-CL03 |
SYNAPSE |
December 22, 2014 |
October 3, 2017 |
October 3, 2017 |
October 7, 2014 |
January 19, 2018 |
|
- The University of Alabama at Birmingham
Birmingham, Alabama, United States - Banner Sun Health Research Institute
Sun City, Arizona, United States - UC San Diego
La Jolla, California, United States - (and 17 more...)
|
19 |
NCT02687542 |
Terminated |
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations |
|
- Drug: Placebo
- Drug: PF-06649751 low dose (1 mg QD)
- Drug: PF-06649751 middle dose 1 (3 mg QD)
- (and 2 more...)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in daily OFF time
- % reduction in total daily L-Dopa dose
- Number of subjects with >=25, 50%, 75% and with 100% reduction in daily L-Dopa dose
- (and 6 more...)
|
108 |
All |
40 Years to 85 Years (Adult, Senior) |
NCT02687542 |
B7601003 2015-004912-39 A-ROSE PD A-ROSE |
|
March 3, 2016 |
November 10, 2017 |
November 10, 2017 |
February 22, 2016 |
February 26, 2018 |
|
- Xenoscience, Inc
Phoenix, Arizona, United States - St Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - Arcadia Neurology Center
Arcadia, California, United States - (and 54 more...)
|
20 |
NCT03305809 |
Recruiting |
A Study of LY3154207 in Participants With Parkinson's Disease Dementia |
- Parkinson's Disease Dementia
|
- Drug: LY3154207
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
- Change from Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
- Change from Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
- (and 12 more...)
|
340 |
All |
40 Years to 85 Years (Adult, Senior) |
NCT03305809 |
16261 I7S-MC-HBEH |
PRESENCE |
November 9, 2017 |
July 12, 2019 |
July 12, 2019 |
October 10, 2017 |
April 18, 2018 |
|
- University of Alabama Birmingham
Birmingham, Alabama, United States - Dignity Health Barrow Neurological Institute
Phoenix, Arizona, United States - Mayo Clinic of Scottsdale
Scottsdale, Arizona, United States - (and 87 more...)
|
21 |
NCT01060878 |
Completed |
Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD) |
|
- Drug: PYM50028
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Unified Parkinson's Disease Rating Scale parts II & III combined score
|
425 |
All |
35 Years to 75 Years (Adult, Senior) |
NCT01060878 |
P58/07CL/ST/09/02 |
CONFIDENT-PD |
November 2010 |
December 2012 |
December 2012 |
February 2, 2010 |
March 4, 2013 |
|
- Mayo Clinic
Scottsdale, Arizona, United States - University of California, Irvine
Irvine, California, United States - Coastal Neurological Medical Group
La Jolla, California, United States - (and 108 more...)
|
22 |
NCT03205488 |
Recruiting |
Nilotinib in Parkinson's Disease |
|
- Drug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg)
- Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1)
- Drug: Placebo
|
Interventional |
Phase 2 |
- Northwestern University
- University of Rochester
- University of Iowa
- Michael J. Fox Foundation for Parkinson's Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Motor Function
|
135 |
All |
40 Years to 79 Years (Adult, Senior) |
NCT03205488 |
NILO-PD |
NILO-PD |
October 16, 2017 |
October 2020 |
October 2020 |
July 2, 2017 |
February 22, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Barrow Neurological Institute
Sun City, Arizona, United States - University of Colorado at Denver
Aurora, Colorado, United States - (and 22 more...)
|
23 |
NCT02615873 |
Recruiting |
A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 |
|
- Drug: Accordion Pill™ Carbidopa/Levodopa
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Unified Parkinson's Disease Rating Scale (UPDRS)
- Safety (Adverse Events, Safety laboratory, Vital signs)
- Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
|
460 |
All |
30 Years to 100 Years (Adult, Senior) |
NCT02615873 |
IN 11 004 OLE |
|
July 2016 |
December 2019 |
December 2019 |
November 26, 2015 |
April 18, 2018 |
|
- University Alabama Hospital Neurology
Birmingham, Alabama, United States - Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States - Banner Sun Health Research Institute
Sun City, Arizona, United States - (and 80 more...)
|
24 |
NCT00880620 |
Completed Has Results |
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease |
|
- Drug: Placebo
- Drug: IPX066 95 mg LD
- Drug: IPX066 145 mg LD
- (and 2 more...)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30
- Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score
|
381 |
All |
30 Years and older (Adult, Senior) |
NCT00880620 |
IPX066-B08-05 |
APEX-PD |
April 2009 |
October 2010 |
November 2010 |
April 14, 2009 |
August 17, 2017 |
February 22, 2016 |
- University of Alabama at Birmingham, Dept. of Neurology
Birmingham, Alabama, United States - HOPE Research Institute, LLC
Phoenix, Arizona, United States - Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States - (and 57 more...)
|
25 |
NCT01096186 |
Completed Has Results |
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease |
|
- Drug: IPX066 95 mg
- Drug: IPX066 145 mg
- Drug: IPX066 195 mg
- Drug: IPX066 245 mg
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III
- Total UPDRS Parts I-IV
- Patient Global Impression (PGI)
|
617 |
All |
30 Years and older (Adult, Senior) |
NCT01096186 |
IPX066-B09-03 |
|
March 2010 |
October 2011 |
October 2011 |
March 31, 2010 |
March 10, 2017 |
March 3, 2016 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Mohammed Ali Parkinson's Center
Phoenix, Arizona, United States - HOPE Research Institute
Phoenix, Arizona, United States - (and 78 more...)
|
26 |
NCT01141023 |
Recruiting |
Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression |
|
|
Interventional |
Phase 2 |
- Ken Marek, MD
- Institute for Neurodegenerative Disorders
- Michael J. Fox Foundation for Parkinson's Research
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- The mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients, and the comparison of these rates between PD patient subsets and between PD, SWEDD, Prodromal and healthy subjects.
- Comparison between the rates of change in the mean of clinical, imaging and biomic outcomes in early PD patients and between PD and healthy subjects
- Prevalence of measures of clinical, imaging and biomic outcomes in early PD patients and healthy subjects.
- (and 8 more...)
|
680 |
All |
30 Years and older (Adult, Senior) |
NCT01141023 |
PPMI-001 |
PPMI |
June 2010 |
September 2018 |
December 2018 |
June 10, 2010 |
August 8, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Banner Research Institute
Sun City, Arizona, United States - University of California San Diego
La Jolla, California, United States - (and 21 more...)
|
27 |
NCT02157714 |
Completed |
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease |
|
- Drug: PRX002
- Other: Placebo
|
Interventional |
Phase 1 |
- Prothena Biosciences Limited
- Hoffmann-La Roche
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety and tolerability as determined by number of subjects with adverse events
- Determination of pharmacokinetics parameters
- Immunogenicity as determined by measurement of anti-PRX002 antibodies
|
64 |
All |
40 Years to 80 Years (Adult, Senior) |
NCT02157714 |
PRX002-CL002 |
|
June 2014 |
September 2016 |
|
June 6, 2014 |
October 21, 2016 |
|
- Collaborative Neuroscience Network, LLC
Long Beach, California, United States - Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States - Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States - (and 5 more...)
|
28 |
NCT00605163 |
Unknown † |
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort |
|
|
Observational |
|
- The Parkinson Study Group
- National Institute of Neurological Disorders and Stroke (NINDS)
- H. Lundbeck A/S
- (and 3 more...)
|
Other / NIH / Industry / U.S. Fed |
- Observational Model: Cohort
|
- Unified Parkinson Disease Rating Scale (UPDRS) and β-CIT SPECT imaging of the dopamine transporter.
- University of Pennsylvania Smell Identification Test (UPSIT)
|
530 |
All |
30 Years and older (Adult, Senior) |
NCT00605163 |
U01NS050095_PostCEPT NINDS 5 U01NS050095-02 U01NS050095 |
PostCEPT |
August 2006 |
August 2010 |
|
January 30, 2008 |
March 28, 2008 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - Sun Health Research Institute
Sun City, Arizona, United States - University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States - (and 52 more...)
|
29 |
NCT00449865 |
Terminated Has Results |
NET-PD LS-1 Creatine in Parkinson's Disease |
|
- Drug: creatine
- Other: placebo
|
Interventional |
Phase 3 |
- University of Rochester
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
|
1741 |
All |
Child, Adult, Senior |
NCT00449865 |
U01NS43128 NET-PD CRC |
|
March 2007 |
September 2013 |
May 2014 |
March 21, 2007 |
April 2, 2015 |
April 2, 2015 |
- University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South
Birmingham, Alabama, United States - Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720,
Phoenix, Arizona, United States - Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204,
Fountain Valley, California, United States - (and 47 more...)
|
30 |
NCT00559871 |
Completed |
Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease |
|
|
Interventional |
Phase 2 |
- Juvantia Pharma Ltd
- Santhera Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
- To compare efficacy of 3 different doses of fipamezole with that of placebo on the mean daily 'Off' time, as recorded in the patient diary.
|
180 |
All |
30 Years and older (Adult, Senior) |
NCT00559871 |
SNT-II-004 |
Fjord |
October 2007 |
May 2009 |
May 2009 |
November 16, 2007 |
June 3, 2009 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Neurology Clinic PC
Northport, Alabama, United States - University of Arizona Health Sciences Center
Tucson, Arizona, United States - (and 33 more...)
|
31 |
NCT00985517 |
Active, not recruiting |
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease |
- Idiopathic Parkinson's Disease
|
- Biological: CERE-120: Adeno-Associated Virus Delivery of Neurturin
- Procedure: Sham Surgery
|
Interventional |
Phase 1 Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in UPDRS Part III Motor Examination in the "Off" state
- Incidence, relatedness, severity, and duration of treatment-emergent adverse events
- Changes from baseline in clinical laboratory tests, vital signs, weight, and examination findings
- Clinically significant changes from baseline in brain imaging results
|
60 |
All |
35 Years to 70 Years (Adult, Senior) |
NCT00985517 |
CERE-120-09 |
|
September 2009 |
January 2018 |
March 2018 |
September 28, 2009 |
January 10, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Stanford School of Medicine
Palo Alto, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 8 more...)
|
32 |
NCT00086073 |
Completed |
Parkinson's Research: The Organized Genetics Initiative |
|
|
Observational |
|
- Indiana University School of Medicine
- The Parkinson Study Group
- Children's Hospital Medical Center, Cincinnati
- (and 2 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
1800 |
All |
Child, Adult, Senior |
NCT00086073 |
9703-09 R01NS037167 |
PROGENI |
August 1998 |
|
January 2011 |
June 24, 2004 |
February 16, 2011 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - Parkinson's & Movement Disorder Institute
Fountain Valley, California, United States - University of California Irvine
Irvine, California, United States - (and 55 more...)
|
33 |
NCT00627640 |
Completed |
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa |
- Idiopathic Parkinson's Disease
|
- Drug: Safinimide 50-100 mg/day
- Drug: Matching Placebo
|
Interventional |
Phase 3 |
- Newron Pharmaceuticals SPA
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)
- Evaluate the changes from baseline to W24 in Activities of Daily Living, cognition, dyskinesias, change in global clinical status, motor symptoms, motor fluctuations, change in levopoda dose and Health Related Quality of life
|
549 |
All |
30 Years to 80 Years (Adult, Senior) |
NCT00627640 |
27919 IND: 63,901 EudraCT Number: 2007-002964-90 |
SETTLE |
February 2009 |
January 2012 |
March 2012 |
March 3, 2008 |
March 29, 2013 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Barrow Neurological Institute
Phoenix, Arizona, United States - Mayo Clinic Scottsdale
Scottsdale, Arizona, United States - (and 118 more...)
|
34 |
NCT00099268 |
Completed Has Results |
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy |
|
- Drug: Carbidopa/levodopa/entacapone
- Drug: Immediate release carbidopa/levodopa
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Orion Corporation, Orion Pharma
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Time to First Occurrence of Dyskinesia
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
- Occurrence of Wearing-off
- (and 3 more...)
|
747 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT00099268 |
CELC200A2401 |
STRIDE-PD |
September 2004 |
November 2008 |
November 2008 |
December 10, 2004 |
April 23, 2012 |
March 8, 2011 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Mayo Clinic
Scottsdale, Arizona, United States - Coastal Neurological Medical Group
La Jolla, California, United States - (and 70 more...)
|
35 |
NCT00368108 |
Completed Has Results |
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations |
|
- Drug: 2 mg perampanel
- Drug: 4 mg perampanel
- Drug: placebo comparator
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)
- Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)
- Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)
- Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)
|
752 |
All |
30 Years and older (Adult, Senior) |
NCT00368108 |
E2007-A001-302 |
|
August 2006 |
January 2008 |
January 2008 |
August 24, 2006 |
May 20, 2013 |
February 5, 2013 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - North Alabama Neuroscience Research Associates
Huntsville, Alabama, United States - Pivotal Research Centers
Peoria, Arizona, United States - (and 111 more...)
|
36 |
NCT00740714 |
Terminated Has Results |
Effects of Coenzyme Q10 (CoQ) in Parkinson Disease |
|
- Drug: Coenzyme Q10 with vitamin E
- Drug: placebo with vitamin E
|
Interventional |
Phase 3 |
- Weill Medical College of Cornell University
- National Institute of Neurological Disorders and Stroke (NINDS)
- University of Rochester
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
- Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
- Change in Modified Rankin Scale From Baseline to 16 Months
- (and 20 more...)
|
600 |
All |
30 Years and older (Adult, Senior) |
NCT00740714 |
U01NS050324 U01NS050573 |
QE3 |
December 2008 |
August 2011 |
August 2011 |
August 25, 2008 |
January 31, 2013 |
January 31, 2013 |
- University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
Birmingham, Alabama, United States - Barrow Neurological Clinics At St Joseph`S Hospital & Medical Center, 500 West Thomas Road Suite 720
Phoenix, Arizona, United States - Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
Scottsdale, Arizona, United States - (and 65 more...)
|
37 |
NCT01211587 |
Completed |
A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease |
- Parkinson's Disease With Cognitive Impairments
|
- Drug: safinamide
- Drug: placebo
|
Interventional |
Phase 2 |
- Newron Pharmaceuticals SPA
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Parkinson's Disease Cognitive Rating Scale (PD-CRS)
- PD-CRS subscale scores
- PD-CRS total score
- (and 15 more...)
|
103 |
All |
45 Years to 80 Years (Adult, Senior) |
NCT01211587 |
EMR701165-024 |
|
September 2010 |
April 2012 |
|
September 29, 2010 |
March 29, 2013 |
|
- The Parkinson's Institute
Sunnyvale, California, United States - Mayo Clinic Florida
Jacksonville, Florida, United States - Emory University
Atlanta, Georgia, United States - (and 12 more...)
|
38 |
NCT00400634 |
Completed Has Results |
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease |
- Idiopathic Parkinson's Disease
|
- Genetic: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])
- Procedure: Sham Surgery
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
58 |
All |
35 Years to 75 Years (Adult, Senior) |
NCT00400634 |
CERE-120-02 |
|
November 2006 |
November 2008 |
November 2008 |
November 17, 2006 |
August 14, 2012 |
August 14, 2012 |
- University of Alabama, Birmingham
Birmingham, Alabama, United States - University of California, San Francisco
San Francisco, California, United States - Rush University Medical Center
Chicago, Illinois, United States - (and 6 more...)
|
39 |
NCT00552474 |
Completed |
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease |
- Parkinson Disease
- Movement Disorders
|
- Device: Libra Deep Brain Stimulation System
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
- Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction
|
136 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00552474 |
C-04-01 |
|
October 2005 |
October 2010 |
November 2016 |
November 2, 2007 |
February 24, 2017 |
|
- Loma Linda University School of Medicine
Loma Linda, California, United States - University of Florida
Gainesville, Florida, United States - Universtiy of Miami
Miami, Florida, United States - (and 12 more...)
|
40 |
NCT00809302 |
Terminated |
Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease |
|
- Drug: aplindore MR tablets or Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean change from baseline to end of treatment in the combined scores of Parts II and III of the UPDRS
- The responder rate; Part II and Part III scores (separately) of the UPDRS; mean change from baseline in the modified Schwab and England Activities of Daily Living; time course in UPDRS and in modified S&E-ADL; safety and tolerability of aplindore MR
|
9 |
All |
30 Years and older (Adult, Senior) |
NCT00809302 |
Aplindore-211 |
|
December 2008 |
August 2009 |
October 2009 |
December 17, 2008 |
August 28, 2009 |
|
- University of Alabama At Birmingham (052)
Birmingham, Alabama, United States - Mayo Clinic Arizona (060)
Scottsdale, Arizona, United States - The Parkinson's Institute (012)
Sunnyvale, California, United States - (and 22 more...)
|
41 |
NCT00617019 |
Completed |
Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study) |
|
|
Observational |
|
|
Industry |
- Observational Model: Ecologic or Community
- Time Perspective: Cross-Sectional
|
- Occurrence of current ImpulseControl Disorder(ICD) assessed via + res. of Modif.Massachusetts Gambling Screen,Modif.Minnesota Impulsive Disorder Interview for Sexuality,Modif.MIDI for Compulsive Buying,DSM-IV binge-eating research criteria questionnaire
- The occurrence of a past (since onset of PD) ICD
- Demographic and medical history measures
- Scores on psychiatric/neuropsychological instruments/tests
|
3234 |
All |
30 Years to 75 Years (Adult, Senior) |
NCT00617019 |
248.619 DOMINION |
|
September 2006 |
January 2008 |
|
February 15, 2008 |
November 13, 2013 |
|
- 248.619.01034 Neurological Physicians of Arizona
Gilbert, Arizona, United States - 248.619.01007 Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States - 248.619.01025 Sun Health Research Institute
Sun City, Arizona, United States - (and 46 more...)
|
42 |
NCT03051607 |
Terminated |
A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose "Wearing-Off" |
- Idiopathic Parkinson Disease
|
|
Interventional |
Phase 3 |
- Biotie Therapies Inc.
- Acorda Therapeutics
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment Emergent Adverse Events (TEAEs)
- Vital Signs
- Electrocardiograms (ECGs)
- Clinical Laboratory Tests
|
66 |
All |
30 Years to 80 Years (Adult, Senior) |
NCT03051607 |
TOZ-CL06 |
|
April 10, 2017 |
January 16, 2018 |
January 16, 2018 |
February 13, 2017 |
January 19, 2018 |
|
- Barrow Neurology Clinics, St. Joseph's Hospital and Medical Center, Dignity Health
Phoenix, Arizona, United States - University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States - Collaborative Neuroscience Network, LLC
Long Beach, California, United States - (and 32 more...)
|
43 |
NCT01629043 |
Recruiting |
National Parkinson Foundation Quality Improvement Initiative |
|
|
Observational |
|
- National Parkinson Foundation
- National Parkinson Foundation
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
|
10000 |
All |
Child, Adult, Senior |
NCT01629043 |
NPF-QII |
NPF-QII |
July 2009 |
|
|
June 27, 2012 |
May 30, 2017 |
|
- Barrow Neurological Institute - Muhammad Ali Parkinson Center
Phoenix, Arizona, United States - Parkinson's Institute and Clinical Center
Sunnyvale, California, United States - Georgetown University Hospital
Washington, D.C., District of Columbia, United States - (and 21 more...)
|
44 |
NCT00040404 |
Terminated |
Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease |
|
- Drug: CEP-1347 10mg
- Drug: CEP1347 25mg
- Drug: CEP-1347 50mg
- Other: Placebo Comparator
|
Interventional |
Phase 2 Phase 3 |
- Cephalon
- H. Lundbeck A/S
- The Parkinson Study Group
- Teva Pharmaceutical Industries
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with disability using United Parkinson's Disease Rating Scale (UPDRS)
- Change from Baseline to 22 months in ([123I]β-CIT) Uptake Participants
- Safety and Tolerability as assessed by the number of participants experiencing adverse events
|
806 |
All |
30 Years and older (Adult, Senior) |
NCT00040404 |
C1347c/204/PD/US-CA |
|
March 2002 |
August 2005 |
August 2005 |
June 27, 2002 |
May 10, 2012 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - Mayo Clinic Arizona
Scottsdale, Arizona, United States - University of Arkansas for Medical Services
Little Rock, Arkansas, United States - (and 63 more...)
|
45 |
NCT00086190 |
Completed Has Results |
Study of Antidepressants in Parkinson's Disease |
- Parkinson Disease
- Depression
|
- Drug: paroxetine
- Drug: venlafaxine
- Other: placebo
|
Interventional |
Phase 3 |
- University of Rochester
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Hamilton Depression Rating Scale (HAM-D) Scores
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)
- Change in Beck Depression Inventory II (BDI-II)
- (and 14 more...)
|
115 |
All |
30 Years and older (Adult, Senior) |
NCT00086190 |
R01NS046487 |
SAD-PD |
June 2005 |
November 2009 |
November 2009 |
June 29, 2004 |
January 4, 2013 |
January 4, 2013 |
- University of California San Francisco
San Francisco, California, United States - University of Florida
Gainesville, Florida, United States - University of Miami
Miami, Florida, United States - (and 15 more...)
|
46 |
NCT02605434 |
Recruiting |
A Study to Assess the Efficacy and Safety of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients |
|
- Drug: Accordion Pill™ Carbidopa/Levodopa
- Drug: Sinemet®
- Drug: Placebo -AP-CD/LD
- Drug: Placebo- Sinemet
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours
- Change from Baseline through study completion, an average of 27 weeks, in "On time" without troublesome dyskinesia during waking hours
- Change in the number of total daily LD doses from Baseline through study completion, an average of 27 weeks (hours)
- (and 2 more...)
|
420 |
All |
30 Years and older (Adult, Senior) |
NCT02605434 |
IN 11 004 |
Accordance |
March 2016 |
September 2018 |
September 2018 |
November 16, 2015 |
April 18, 2018 |
|
- University Alabama Hospital Neurology
Birmingham, Alabama, United States - Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States - Parkinson's Disease & Movement Disorders Center, Dept of Neu
Fountain Valley, California, United States - (and 97 more...)
|
47 |
NCT00134966 |
Completed |
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa |
|
- Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Symptom control change from baseline to week 39
- Change from baseline to week 39 in activities of daily living
- Change from baseline to week 39 in motor function
- (and 2 more...)
|
493 |
All |
30 Years to 80 Years (Adult, Senior) |
NCT00134966 |
CELC200A2305 |
|
August 2005 |
September 2007 |
September 2007 |
August 25, 2005 |
May 17, 2017 |
|
- Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
Phoenix, Arizona, United States - Coastal Neurological Medical Group, Inc
La Jolla, California, United States - Neurosearch, Inc.
Reseda, California, United States - (and 57 more...)
|
48 |
NCT01076452 |
Completed Has Results |
Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial |
|
- Device: Bilateral Deep Brain Stimulation
|
Interventional |
Phase 3 |
- VA Office of Research and Development
- National Institute of Neurological Disorders and Stroke (NINDS)
- Medtronic
|
U.S. Fed / NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.
- The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.
- The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.
- The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.
|
299 |
All |
22 Years and older (Adult, Senior) |
NCT01076452 |
468 Phase II VA-NINDS-01 |
|
April 2002 |
October 2008 |
April 2009 |
February 26, 2010 |
July 14, 2014 |
January 15, 2014 |
- University of California at Los Angeles
Los Angeles, California, United States - University of California at San Francisco
San Francisco, California, United States - VA Medical Center, San Francisco
San Francisco, California, United States - (and 11 more...)
|
49 |
NCT00056563 |
Completed Has Results |
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial |
|
- Device: Bilateral Deep Brain Stimulation
- Other: best medical therapy
|
Interventional |
Phase 3 |
- VA Office of Research and Development
- National Institute of Neurological Disorders and Stroke (NINDS)
|
U.S. Fed / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.
- The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation
|
255 |
All |
22 Years and older (Adult, Senior) |
NCT00056563 |
468 Phase I |
|
April 2002 |
October 2008 |
October 2008 |
March 19, 2003 |
May 9, 2014 |
July 30, 2013 |
- University of California at Los Angeles
Los Angeles, California, United States - VA Medical Center, San Francisco
San Francisco, California, United States - University of California at San Francisco
San Francisco, California, United States - (and 11 more...)
|
50 |
NCT00605683 |
Completed |
MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist |
- Idiopathic Parkinson's Disease
|
- Drug: Safinamide (as add-on therapy)
|
Interventional |
Phase 3 |
- Newron Pharmaceuticals SPA
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).
- Evaluate the changes from baseline to W24 in activities of daily living, cognition, change in global clinical status, responder rates with regard to motor symptoms and health related quality of life
|
679 |
All |
30 Years to 80 Years (Adult, Senior) |
NCT00605683 |
27918 63,901 EudraCT: 2007-002963-28 |
MOTION |
November 2007 |
January 2012 |
March 2012 |
January 31, 2008 |
October 29, 2013 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Arizona Neurological Institute
Phoenix, Arizona, United States - Pacific Neuroscience Medical Group
Oxnard, California, United States - (and 122 more...)
|