1 |
NCT02381444 |
Recruiting |
Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy |
- Advanced Parkinson's Disease
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Change in the Parkinson's Disease Questionnaire (PDQ-39) summary index
- Change in Health Related Quality of Life (HRQL)
- Change in participant's motor symptoms
- (and 4 more...)
|
266 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02381444 |
P14-322 |
BALANCE |
April 17, 2015 |
December 31, 2019 |
December 31, 2019 |
March 6, 2015 |
February 19, 2018 |
|
- Uniklinik Koln
Köln, Nordrhein-Westfalen, Germany - Klinikum Altenburger Land
Altenburg, Germany - Hummel/N/W, Bad Krozingen, DE
Bad Krozingen, Germany - (and 41 more...)
|
2 |
NCT01736176 |
Completed Has Results |
A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease |
- Advanced Parkinson's Disease
|
- Drug: Levodopa-Carbidopa Intestinal Gel
- Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)
- Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score
- Number of Participants Who Used Healthcare Resources During the First 4 Weeks
- Number of Participants With Adverse Events
- (and 35 more...)
|
39 |
All |
30 Years and older (Adult, Senior) |
NCT01736176 |
M12-920 |
|
March 2013 |
March 2015 |
December 2015 |
November 29, 2012 |
February 8, 2017 |
February 8, 2017 |
|
3 |
NCT02549092 |
Recruiting |
A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) |
- Advanced Parkinson's Disease
|
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score
- Change in the Non-Motor Symptoms Scale (NMSS) Total Score
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- (and 13 more...)
|
88 |
All |
30 Years to 99 Years (Adult, Senior) |
NCT02549092 |
M12-927 2014-004865-26 |
|
September 10, 2015 |
November 30, 2018 |
November 30, 2018 |
September 15, 2015 |
February 2, 2018 |
|
- Parkinson's and Movement
Fountain Valley, California, United States - Georgetown University Hospital
Washington, District of Columbia, United States - Boca Raton Regional Hospital
Boca Raton, Florida, United States - (and 30 more...)
|
4 |
NCT02604914 |
Completed |
A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects |
|
|
Interventional |
Phase 1 |
- NeuroDerm Ltd.
- Quotient Clinical
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cmax (maximal plasma concentration) of CD for different doses of CD
- AUC (area under the curve) of CD for different doses of CD
- Cmax (maximal plasma concentration) of LD and CD for ND0612 vs. LCIG
- AUC (area under the curve) of LD and CD for ND0612. LCIG
|
36 |
All |
40 Years to 65 Years (Adult) |
NCT02604914 |
ND0612-005 |
|
June 2015 |
May 2016 |
May 2016 |
November 16, 2015 |
May 25, 2016 |
|
- Quotient Clinical LTD
Ruddington, Nottingham, United Kingdom
|
5 |
NCT03362879 |
Recruiting |
COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Percentage of patients on Levodopa-Carbidopa Intestinal Gel (LCIG) monotherapy from LCIG initiation to 12 months
- The percentage of patients on LCIG monotherapy from immediately following LCIG initiation to 12 months in participating countries with at least 20 subjects enrolled
- Time from initial LCIG administration to the initiation of LCIG monotherapy
- (and 10 more...)
|
28 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03362879 |
P16-831 |
COSMOS |
December 14, 2017 |
December 14, 2018 |
December 14, 2018 |
December 5, 2017 |
March 6, 2018 |
|
- Ottawa Hospital
Ottawa, Ontario, Canada - Toronto Western Hospital
Toronto, Ontario, Canada - Hopital Notre Dame
Montreal, Quebec, Canada - (and 19 more...)
|
6 |
NCT02274324 |
Unknown † |
Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease |
|
- Dietary Supplement: different diets
|
Interventional |
Not Applicable |
- Sheba Medical Center
- Tel Aviv University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- quality of life
- dyskinesias
- fluctuations
- motor function
|
20 |
All |
40 Years to 80 Years (Adult, Senior) |
NCT02274324 |
1310-14-SMC |
|
October 2014 |
October 2017 |
December 2017 |
October 24, 2014 |
October 24, 2014 |
|
|
7 |
NCT01960842 |
Completed Has Results |
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications |
- Advanced Parkinson's Disease
|
- Drug: Levodopa-carbidopa intestinal gel
- Device: CADD-Legacy® 1400 ambulatory infusion pump
- Device: PEG tube
- Device: J-tube
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Average Daily Normalized "Off" Time: Change From Baseline To The Final PEG-J Visit
- Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit
- Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit
- (and 17 more...)
|
31 |
All |
30 Years and older (Adult, Senior) |
NCT01960842 |
M12-921 |
|
October 2013 |
March 2015 |
March 2015 |
October 11, 2013 |
April 20, 2016 |
April 20, 2016 |
|
8 |
NCT03419806 |
Recruiting |
Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease |
|
- Drug: Infudopa i.v.
- Drug: Infudopa s.c.
- Drug: LCIG (Duodopa)
|
Interventional |
Phase 1 |
- Vastra Gotaland Region
- The Swedish Research Council
- Dizlin Medical Design AB
- Göteborg University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Steady state plasma concentration - levodopa
- Steady state plasma concentration - carbidopa
- Peak-through fluctuation of plasma concentration - levodopa
- (and 18 more...)
|
28 |
All |
30 Years and older (Adult, Senior) |
NCT03419806 |
2017-002488-17 |
IPO-001 |
February 16, 2018 |
December 2018 |
December 2018 |
February 2, 2018 |
March 7, 2018 |
|
- Sahlgrenska Universtiy Hospital, Dep of Neurology
Gothenburg, Sweden
|
9 |
NCT02799381 |
Recruiting |
A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease |
- Advanced Parkinson's Disease
|
- Drug: ABT-SLV187
- Drug: optimized antiparkinsonian treatment
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Unified Dyskinesia Rating Scale (UDysRS) Total Score
- Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination)
- OFF time
- (and 4 more...)
|
60 |
All |
30 Years to 99 Years (Adult, Senior) |
NCT02799381 |
M15-535 2016-001403-23 |
DYSCOVER |
February 13, 2017 |
January 31, 2020 |
January 31, 2020 |
June 14, 2016 |
April 2, 2018 |
|
- Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, United States - Central Texas Neurology Consul
Round Rock, Texas, United States - Helsinki Univ Central Hospital
Helsinki, Finland - (and 19 more...)
|
10 |
NCT00360568 |
Completed Has Results |
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects |
- Dyskinesias
- Parkinson's Disease
- Severe Motor Fluctuations
|
- Drug: Levodopa-carbidopa intestinal gel
- Device: CADD-Legacy® 1400 ambulatory infusion pump
- Device: PEG tube
- Device: J-tube
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- Quintiles, Inc.
- AbbVie
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
- Number of Participants With Device Complications
- Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
- (and 31 more...)
|
62 |
All |
30 Years and older (Adult, Senior) |
NCT00360568 |
S187.3.003 2006-000578-53 |
|
June 2009 |
October 2012 |
October 2012 |
August 4, 2006 |
January 16, 2015 |
January 16, 2015 |
- Site Reference ID/Investigator# 45869
Birmingham, Alabama, United States - Site Reference ID/Investigator# 45834
Fountain Valley, California, United States - Site Reference ID/Investigator# 45854
Los Angeles, California, United States - (and 19 more...)
|
11 |
NCT00335153 |
Completed Has Results |
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease |
- Advanced Parkinson's Disease
|
- Drug: Levodopa-carbidopa intestinal gel
- Device: CADD-Legacy® 1400 ambulatory infusion pump
- Device: PEG tube
- Device: J-tube
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- Quintiles, Inc.
- AbbVie
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs
- Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period
- Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods
- (and 31 more...)
|
354 |
All |
30 Years and older (Adult, Senior) |
NCT00335153 |
S187.3.004 2006-005186-18 |
|
January 2008 |
June 2012 |
June 2012 |
June 9, 2006 |
January 16, 2015 |
January 16, 2015 |
- Site Reference ID/Investigator# 50065
Birmingham, Alabama, United States - Site Reference ID/Investigator# 50059
Fountain Valley, California, United States - Site Reference ID/Investigator# 50048
Los Angeles, California, United States - (and 80 more...)
|
12 |
NCT00660387 |
Completed Has Results |
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects |
- Advanced Parkinson's Disease
|
- Drug: Levodopa carbidopa intestinal gel (LCIG)
- Drug: Placebo Gel
- Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets
- (and 4 more...)
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- Quintiles, Inc.
- AbbVie
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
- Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12
- Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12
- (and 21 more...)
|
35 |
All |
30 Years and older (Adult, Senior) |
NCT00660387 |
S187.3.002 2007-003814-32 |
|
December 2009 |
October 2011 |
October 2011 |
April 17, 2008 |
January 16, 2015 |
January 16, 2015 |
- Site Reference ID/Investigator# 45931
Birmingham, Alabama, United States - Site Reference ID/Investigator# 45910
Fountain Valley, California, United States - Site Reference ID/Investigator# 45925
Oceanside, California, United States - (and 11 more...)
|
13 |
NCT00357994 |
Completed Has Results |
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects |
- Advanced Parkinson's Disease
|
- Drug: Levodopa carbidopa intestinal gel (LCIG)
- Drug: Placebo gel
- Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
- (and 4 more...)
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- Quintiles, Inc.
- AbbVie
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
- Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12
- Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12
- (and 21 more...)
|
36 |
All |
30 Years and older (Adult, Senior) |
NCT00357994 |
S187.3.001 2006-000577-29 |
|
January 2009 |
October 2011 |
October 2011 |
July 28, 2006 |
January 16, 2015 |
January 16, 2015 |
- Site Reference ID/Investigator# 45719
Los Angeles, California, United States - Site Reference ID/Investigator# 45718
Englewood, Colorado, United States - Site Reference ID/Investigator# 45722
Washington, District of Columbia, United States - (and 12 more...)
|
14 |
NCT01956032 |
Completed Has Results |
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources |
|
|
Observational |
|
|
Industry |
- Time Perspective: Prospective
|
- Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
- Median Number of Contacts
- Median Total Time for Titration
- (and 41 more...)
|
15 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT01956032 |
P14-000 |
|
September 2013 |
November 2014 |
November 2014 |
October 8, 2013 |
February 23, 2016 |
January 25, 2016 |
|
15 |
NCT00660673 |
Active, not recruiting |
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD |
- Advanced Parkinson's Disease
|
- Drug: Levodopa-carbidopa intestinal gel
- Device: CADD-Legacy® 1400 ambulatory infusion pump
|
Interventional |
Phase 3 |
- AbbVie (prior sponsor, Abbott)
- Quintiles, Inc.
- AbbVie
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse Events
- Long Term Safety and Maintenance of Efficacy
|
262 |
All |
30 Years to 99 Years (Adult, Senior) |
NCT00660673 |
S187.3.005 2008-001329-33 |
|
November 13, 2009 |
September 15, 2020 |
September 30, 2020 |
April 17, 2008 |
February 16, 2018 |
|
- University of Alabama
Birmingham, Alabama, United States - The Research Ctr Southern CA
Encinitas, California, United States - Parkinson's and Movement
Fountain Valley, California, United States - (and 58 more...)
|
16 |
NCT01479127 |
Completed Has Results |
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease |
- Advanced Parkinson's Disease
|
- Drug: ABT-SLV187
- Drug: Oral Levodopa/Carbidopa
- Device: Infusion Pump: CADD-Legacy® 1400 Pump
- (and 2 more...)
|
Interventional |
Phase 2 |
- AbbVie (prior sponsor, Abbott)
- Abbott Japan Co.,Ltd
- AbbVie
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period
- Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period
- Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period
- (and 21 more...)
|
8 |
All |
30 Years to 99 Years (Adult, Senior) |
NCT01479127 |
M12-925 |
|
October 2011 |
July 2012 |
July 2012 |
November 24, 2011 |
April 21, 2016 |
March 15, 2016 |
|
17 |
NCT00141518 |
Completed Has Results |
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact |
- Advanced Idiopathic Parkinson's Disease
|
- Drug: Levodopa-carbidopa intestinal gel (LCIG)
- Device: CADD-Legacy® 1400 ambulatory infusion pump
- Device: percutaneous endoscopic gastrostomy tube (PEG tube)
- Device: jejunal extension tube (J-tube)
|
Interventional |
Phase 4 |
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12
- Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12
- EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12
- (and 50 more...)
|
77 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT00141518 |
S187.4.001 2005-002654-21 |
DAPHNE |
March 2006 |
March 2011 |
April 2011 |
September 1, 2005 |
July 18, 2016 |
July 18, 2016 |
|
18 |
NCT02485600 |
Recruiting |
Observational Study Evaluating Long-term Health Outcomes of Canadian DUODOPA-treated Patients |
- Advanced Parkinson's Disease
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in participant's motor symptoms
- Change in the cognitive functions.
- Change in the Parkinson's Disease Questionnaire (PDQ-39)
- (and 4 more...)
|
200 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02485600 |
P14-506 |
|
October 19, 2015 |
April 1, 2021 |
April 1, 2021 |
June 30, 2015 |
March 22, 2018 |
|
- University of Calgary
Calgary, Alberta, Canada - GILDR
Edmonton, Alberta, Canada - Univ British Columbia
Vancouver, British Columbia, Canada - (and 13 more...)
|
19 |
NCT02611713 |
Active, not recruiting |
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease |
- Advanced Parkinson's Disease
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in the number of hours spent in OFF time
- Change in Disease-Specific Caregiver Burden
- Change in the Duration of Dyskinesia
- (and 13 more...)
|
210 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02611713 |
P14-494 |
DUOGLOBE |
January 4, 2016 |
March 27, 2021 |
March 27, 2021 |
November 23, 2015 |
February 2, 2018 |
|
- University of Alabama
Birmingham, Alabama, United States - Parkinson's Disease and Moveme
Boca Raton, Florida, United States - University of Florida
Gainesville, Florida, United States - (and 50 more...)
|