| 1 |
NCT03487367 |
Not yet recruiting
New |
Clinical Trial Readiness for SCA1 and SCA3 |
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia 3
|
|
Observational |
|
- Tetsuo Ashizawa, MD
- University of Michigan
- University of Minnesota - Clinical and Translational Science Institute
- (and 18 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in disease progression in SCA1 and SCA3 as determined by change in scale for the assessment and rating of ataxia (SARA) score over time.
- Change in disease progression in SCA1 and SCA3 as determined by change in Composite Cerebellar Functional Severity Score (CCFS) total score over time.
- Change in disease progression in SCA1 and SCA3 as determined by change in timed 25 foot walk test (T25FW) over time.
- (and 16 more...)
|
200 |
All |
18 Years to 65 Years (Adult) |
NCT03487367 |
Pro00017836
U01 - Ashizawa 2016 |
|
May 31, 2018 |
December 2022 |
December 2022 |
April 4, 2018 |
April 10, 2018 |
|
|
| 2 |
NCT01037777 |
Unknown † |
RISCA : Prospective Study of Individuals at Risk for SCA1, SCA2, SCA3, SCA6, SCA7 |
|
|
Observational |
|
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01037777 |
C08-37 |
RISCA |
May 2009 |
|
|
December 23, 2009 |
January 31, 2012 |
|
- Pitié Salpêtrière Hospital
Paris, France
|
| 3 |
NCT02741440 |
Recruiting |
Natural History of Spinocerebellar Ataxia Type 7 (SCA7) |
|
|
Observational |
|
- National Eye Institute (NEI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Other
|
- The primary outcome for this study is determination of the amplitude and time of photopic and scotopic responses on electroretinogram.
- Secondary outcomes include changes in visual acuity, microperimetry, peripheral visual field, color vision, macular thickness, and neurologic outcome variables.
- Exploratory outcomes include: 1)formulation of clinical outcome measures for future studies and 2)acquisition and preliminary analysis of data that may advance our understanding of the progression of retinal and neurodegeneration associated SCA7...
|
25 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02741440 |
160090
16-EI-0090 |
|
April 13, 2016 |
February 28, 2019 |
March 2, 2019 |
April 18, 2016 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
| 4 |
NCT00683943 |
Completed |
Lithium Treatment for Patients With Spinocerebellar Ataxia Type I |
- Spinocerebellar Ataxia Type I
|
|
Interventional |
Phase 1 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of side effects, side effect profile, and number of falls.
- ICARS scores, SARA scores, Quantitative Sway/Balance assessment, Tremor Rating Scale scores, dexterity evaluation, sleep questionnaire, Computerized Continuous Performing Tasks assessment
|
13 |
All |
18 Years to 65 Years (Adult) |
NCT00683943 |
080134
08-N-0134 |
|
May 18, 2008 |
February 25, 2010 |
February 25, 2010 |
May 26, 2008 |
April 24, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 5 |
NCT03336008 |
Recruiting |
Hong Kong Spinocerebellar Ataxias Registry |
|
|
Observational |
|
- Chinese University of Hong Kong
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Scale for the assessment and rating of ataxia (SARA) score
- Unified Huntington's Disease Rating Scale IV
- EQ5D Health questionnaire
- Patient Health Questionnaire-9 (PHQ-9)
|
70 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03336008 |
HK_SCA_Registry |
HK_SCA_Reg |
December 7, 2012 |
December 31, 2018 |
December 31, 2018 |
November 8, 2017 |
November 8, 2017 |
|
- Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
|
| 6 |
NCT03347344 |
Not yet recruiting |
Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL) |
- Spinocerebellar Ataxia Type 2
|
- Drug: Riluzole
- Drug: Placebo
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in Ataxia symptoms (Scale for the Assessment and Rating of Ataxia (SARA))
- Change in Ataxia symptoms (Composite Cerebellar Functional Severity (CCFS) score)
- Change in extracerebellar symptoms (Inventory of Non-Ataxia Signs (INAS))
- 12 months survival
|
42 |
All |
18 Years and older (Adult, Senior) |
NCT03347344 |
P160927J
2017-001481-23 |
ATRIL |
November 2017 |
November 2019 |
November 2019 |
November 20, 2017 |
November 20, 2017 |
|
|
| 7 |
NCT01975909 |
Completed
Has Results |
Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia |
|
- Device: Transcranial Magnetic Stimulation
|
Interventional |
Not Applicable |
- Beth Israel Deaconess Medical Center
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
- Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk
- Percent Change From Baseline to Post Treatment on the 9-hole Peg Test
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01975909 |
2013P000233
1R21NS085491-01 |
TMS |
September 2013 |
October 2016 |
November 2016 |
November 5, 2013 |
May 30, 2017 |
May 30, 2017 |
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
| 8 |
NCT03378414 |
Not yet recruiting |
Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Spinocerebellar Ataxia |
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- Spinocerebellar Ataxia Type 3
- Spinocerebellar Ataxia Type 6
|
- Procedure: Intravenous infusion
- Procedure: Intrathecal injection
- Biological: umbilical cord mesenchymal stem cell
|
Interventional |
Phase 2 |
- Sclnow Biotechnology Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scale for the assessment anf rating of ataxia (SARA)
- Image examinations
- Inventory of Non-Ataxia Symptoms (INAS) score
- Cerebrospinal fluid (csf) routine
|
45 |
All |
16 Years to 60 Years (Child, Adult) |
NCT03378414 |
SCLnow-XY-03 |
|
January 2018 |
January 2019 |
December 2019 |
December 19, 2017 |
December 19, 2017 |
|
|
| 9 |
NCT02287064 |
Recruiting |
An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias |
|
- Drug: Intravenous Immune Globulin (IVIG)
|
Interventional |
Phase 1 |
- University of South Florida
- Baxter Healthcare Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in Scale for the Assessment and Rating Ataxia (SARA)
- clinician and patient global impression of improvement (CGI and PGI)
- Neurologic dysfunction as assessed by STAND scores
- 9-hole peg test
|
10 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02287064 |
SCA IVIG 2014 |
|
April 2015 |
December 2016 |
|
November 10, 2014 |
June 8, 2016 |
|
- University of South Florida
Tampa, Florida, United States
|
| 10 |
NCT00654251 |
Completed |
Measuring Neurological Impairment and Functional Visual Assessment In Spinocerebellar Ataxias |
|
|
Observational |
|
- University of Mississippi Medical Center
- University of Texas
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Home based gait data vs SARA index
- Barthel Index
- Visual function- acuity, contrast, stereo, color
- Ocular Motility defects- phoria/tropia, vergence amplitudes
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00654251 |
2007-0228 |
|
February 2008 |
February 2009 |
February 2009 |
April 7, 2008 |
April 29, 2009 |
|
- University of Mississippi Medical Center
Jackson, Mississippi, United States - University of Texas Medical Branch
Galveston, Texas, United States
|
| 11 |
NCT01350440 |
Completed |
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia |
|
|
Interventional |
Phase 2 |
- University of South Florida
- Baxter Healthcare Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scale for the Assessment and Rating of Ataxia
- Timed 25 foot walk
- Clinical Global impression
- (and 5 more...)
|
5 |
All |
10 Years to 50 Years (Child, Adult) |
NCT01350440 |
10 |
|
August 2011 |
July 2013 |
July 2013 |
May 9, 2011 |
July 23, 2013 |
|
- University of South Florida
Tampa, Florida, United States
|
| 12 |
NCT00998634 |
Completed |
Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2) |
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Primary endpoint of the study will be the difference in the number and frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) recorded during the study, between treatment and placebo group.
- Secondary outcome will be the Scale for the Assessment and Rating of Ataxia (SARA). Statistical analysis will be performed to compare the effect of treatment on both groups.
- Micro- and macrostructural Magnetic Resonance parameters will be compared before and after treatment. This will include Voxel Based Morphometry, resting functional MRI, Diffusion tensor imaging and MRI spectroscopy.
- (and 2 more...)
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00998634 |
SCA_LITIO_12
EUDRACT N°2009−016317−20 |
LISCA2 |
October 2009 |
November 2012 |
November 2012 |
October 20, 2009 |
January 8, 2013 |
|
- Dipartimento di Scienze Neurologiche
Napoli, Italy
|
| 13 |
NCT01934998 |
Completed |
Parkinsonism in Spinocerebellar Ataxia Type 6 |
- Spinocerebellar Ataxia Type 6
|
|
Observational |
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- The primary outcome would be the clinical feature of the parkinsonism and change in DAT density in putamen and caudate
- The secondary outcome would be the INAS score
- The secondary outcome would also be the SARA score
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01934998 |
12-1335 |
|
July 2013 |
April 2015 |
April 2015 |
September 4, 2013 |
April 28, 2015 |
|
- University of Chicago
Chicago, Illinois, United States
|
| 14 |
NCT01060371 |
Recruiting |
Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias |
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- Spinocerebellar Ataxia Type 3
- Spinocerebellar Ataxia Type 6
|
- Genetic: All Participants
|
Observational |
|
- University of Florida
- National Ataxia Foundation
- University of California, Los Angeles
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The disease's progression over time using clinical rating scales and timed performance measures.
- Relation between the genetic modifiers and the age at onset of disease and disease progression rates.
- The effects of the disease on the Activities of Daily Living (ADL)in patients with Spinocerebellar Ataxias
|
800 |
All |
6 Years and older (Child, Adult, Senior) |
NCT01060371 |
IRB201700740
505-2009 |
|
April 2010 |
June 2018 |
June 2018 |
February 2, 2010 |
August 21, 2017 |
|
- University of California Los Angeles
Los Angeles, California, United States - University of California San Francisco
San Francisco, California, United States - University of Florida
Gainesville, Florida, United States - (and 9 more...)
|
| 15 |
NCT01811706 |
Completed
Has Results |
Dalfampridine and Gait in Spinocerebellar Ataxias |
- Spinocerebellar Ataxias Type 1
- Spinocerebellar Ataxias Type 2
- Spinocerebellar Ataxias Type 3
- Spinocerebellar Ataxias Type 6
|
- Drug: Dalfampridine
- Drug: Placebo
|
Interventional |
Not Applicable |
- University of Florida
- Acorda Therapeutics
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Timed 25 Feet Walking Test (T25FW)
- Change in Scale of Assessment and Rating of Ataxia (SARA)
- Biomechanical Assessment of Gait (BAG)-Stride Length
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01811706 |
20121107
1133511 |
|
February 2013 |
December 2013 |
December 2013 |
March 14, 2013 |
January 12, 2015 |
January 12, 2015 |
- University of Florida
Gainesville, Florida, United States
|
| 16 |
NCT00992771 |
Completed |
Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3 |
- Spinocerebellar Ataxia Type 3
|
- Drug: varenicline
- Drug: placebo
|
Interventional |
Phase 2 |
- University of South Florida
- National Ataxia Foundation
- Bob Allison Ataxia Research Center (BAARC)
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in the patient's SARA Rating Scale total score
- Frequency and severity of dose-limiting adverse events
- The effect of varenicline on quality of life in patients with spinocerebellar ataxia
- (and 2 more...)
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00992771 |
8 |
|
October 2009 |
April 2011 |
April 2011 |
October 9, 2009 |
June 18, 2012 |
|
- University of California - Los Angeles
Los Angeles, California, United States - University of Florida
Gainesville, Florida, United States - University of South Florida
Tampa, Florida, United States
|
| 17 |
NCT02488031 |
Recruiting |
Functional and Structural Imaging and Motor Control in Spinocerebellar Ataxia |
|
- Behavioral: Error-reduction
- Behavioral: International Cooperative Ataxia Rating Scale
- Behavioral: Scale for the Assessment and Rating of Ataxia
- (and 11 more...)
|
Interventional |
Not Applicable |
- University of Florida
- National Institute of Neurological Disorders and Stroke (NINDS)
- University of South Florida
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in the Location of the Movement Endpoint Relative to the Target in the Motor Task
- International Cooperative Ataxia Rating Scale(ICARS) Assessment
- Change in Motor Unit Discharge Rate Variability
- Change in Blood-oxygen-level-dependent(BOLD) Activity of Motor Cortex
|
60 |
All |
21 Years to 85 Years (Adult, Senior) |
NCT02488031 |
IRB201500202-N
R21NS094946 |
SCA |
March 2016 |
August 2019 |
August 2019 |
July 2, 2015 |
April 5, 2018 |
|
- University of Florida
Gainesville, Florida, United States
|
| 18 |
NCT01096082 |
Completed |
Safety and Efficacy of Lithium Carbonate in Patients With Spinocerebellar Ataxia Type 3 |
- Spinocerebellar Ataxia Type 3
- Machado Joseph Disease
|
- Drug: Lithium Carbonate
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Hospital de Clinicas de Porto Alegre
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Phase 2 - Safety and tolerability of Lithium Carbonate treatment in patients with SCA3
- Phase 3 - Efficacy of Lithium Carbonate treatment in patients with SCA3
- Efficacy of Lithium Carbonate in patients with SCA3 on neurological function, ataxic, depressive and quality of life scores
- Effect of Lithium Carbonate treatment in peripheral levels and expression of treatment biomarkers
|
62 |
All |
16 Years to 80 Years (Child, Adult, Senior) |
NCT01096082 |
09-418
HCPA FIPE GPPG: 09-418 |
|
May 2011 |
December 2012 |
January 2013 |
March 30, 2010 |
January 30, 2013 |
|
- Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
|
| 19 |
NCT02103075 |
Completed |
Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia |
|
- Device: Neuromuscular electrical stimulation
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Central Motor Excitability
- Peripheral Motor Excitability
|
29 |
All |
20 Years and older (Adult, Senior) |
NCT02103075 |
91-221 |
|
August 2002 |
October 2005 |
October 2005 |
April 3, 2014 |
April 3, 2014 |
|
- Chang Gung University
Taoyuan, Taiwan
|
| 20 |
NCT00136630 |
Unknown † |
Natural History, Genetic Bases and Phenotype-genotype Correlations in Autosomal Dominant Spinocerebellar Degenerations |
- Spinocerebellar Ataxias
- Spastic Paraplegias
|
|
Observational |
|
- Institut National de la Santé Et de la Recherche Médicale, France
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
|
225 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00136630 |
RBM01-59 _ AOM03059 |
|
May 2005 |
|
December 2012 |
August 29, 2005 |
January 31, 2012 |
|
- Hôpital Pellegrin
Bordeaux, France - CHU de Grenoble
Grenoble, France - Hôpital Neurologique Pierre Wertheimer
Lyon, France - (and 5 more...)
|
| 21 |
NCT01096095 |
Withdrawn |
Pilot Study of Safety and Efficacy of Sodium Phenylbutyrate in Spinocerebellar Ataxia Type 3 |
- Spinocerebellar Ataxia Type 3
|
- Drug: Placebo
- Drug: Sodium Phenylbutyrate
|
Interventional |
Phase 2 |
- Hospital de Clinicas de Porto Alegre
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety and tolerability of phenylbutyrate in patients with SCA3
- Efficacy of phenylbutyrate in SCA3 on neurological dysfunction and quality of life
|
0 |
All |
16 Years to 80 Years (Child, Adult, Senior) |
NCT01096095 |
CONEP CAAE 0527.0.001.000-07 |
|
June 2010 |
December 2010 |
July 2011 |
March 30, 2010 |
August 17, 2012 |
|
- Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
|
| 22 |
NCT02960893 |
Active, not recruiting |
Trial in Adult Subjects With Spinocerebellar Ataxia |
- Spinocerebellar Ataxias
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- (and 5 more...)
|
- Drug: BHV-4157
- Drug: Placebo Comparator
|
Interventional |
Phase 2
Phase 3 |
- Biohaven Pharmaceutical Holding Company Ltd.
- Cognitive Research Corporation
- Cytel Inc.
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To measure the change in total score on the Scale for Assessment and Rating of Ataxia (SARA)
- • To assess the safety and tolerability of BHV-4157 in subjects with SCA by measuring the frequency and severity of adverse events and discontinuations of adverse events.
- To compare efficacy of BHV-4157 with placebo on patient impression of benefit via use of the PGI-C
|
120 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02960893 |
BHV4157-201 |
|
December 2016 |
August 18, 2017 |
August 2018 |
November 10, 2016 |
August 24, 2017 |
|
- St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - CNS Trial
Long Beach, California, United States - University of California, Los Angeles
Los Angeles, California, United States - (and 15 more...)
|
| 23 |
NCT01970124 |
Completed |
A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373, High dose
- Drug: KPS-0373, Low dose
|
Interventional |
Phase 3 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
|
- SARA (Scale for the Assessment and Rating of Ataxia)
- SF-8 (QOL)
|
|
All |
20 Years and older (Adult, Senior) |
NCT01970124 |
KPS1303 |
|
|
May 2015 |
|
October 25, 2013 |
April 18, 2016 |
|
- Tokyo and Other Japanese Cities, Japan
|
| 24 |
NCT01970137 |
Completed |
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373, High dose
- Drug: KPS-0373, Low dose
|
Interventional |
Phase 3 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
|
- SARA (Scale for the Assessment and Rating of Ataxia)
- SF-8 (QOL)
|
|
All |
20 Years and older (Adult, Senior) |
NCT01970137 |
KPS1304 |
|
|
October 2014 |
|
October 25, 2013 |
April 18, 2016 |
|
- Tokyo and Other Japanese Cities, Japan
|
| 25 |
NCT01970111 |
Completed |
An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373, High dose
- Drug: KPS-0373, Low dose
|
Interventional |
Phase 3 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
|
- SARA (Scale for the Assessment and Rating of Ataxia)
- SF-8 (QOL)
|
|
All |
20 Years and older (Adult, Senior) |
NCT01970111 |
KPS1302 |
|
|
July 2015 |
|
October 25, 2013 |
April 18, 2016 |
|
- Tokyo and Other Japanese Cities, Japan
|
| 26 |
NCT01970098 |
Completed |
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373, High dose
- Drug: KPS-0373, Low dose
- Drug: Placebo
|
Interventional |
Phase 3 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
|
- SARA (Scale for the Assessment and Rating of Ataxia)
- SF-8 (QOL)
|
|
All |
20 Years and older (Adult, Senior) |
NCT01970098 |
KPS1301 |
|
|
January 2015 |
|
October 25, 2013 |
April 18, 2016 |
|
- Tokyo and Other Japanese Cities, Japan
|
| 27 |
NCT01004016 |
Completed |
A Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373
- Drug: Placebo
|
Interventional |
Phase 2 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Scale for Assessment and Rating of Ataxia (SARA)
- Upper and lower extremity function
|
20 |
All |
20 Years and older (Adult, Senior) |
NCT01004016 |
KPS1202 |
|
|
|
|
October 29, 2009 |
September 28, 2010 |
|
|
| 28 |
NCT00863538 |
Completed |
Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
|
Interventional |
Phase 2 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scale for the assessment and rating of ataxia (SARA), ADL(Flow-FIM), Patient Improvement Impression
|
40 |
All |
20 Years and older (Adult, Senior) |
NCT00863538 |
KPS1201 |
|
|
|
|
March 18, 2009 |
February 3, 2010 |
|
- Japan
Hokkaido Region, Japan - Japan
Kansai Region, Japan - Japan
Kanto Region, Japan
|
| 29 |
NCT02440763 |
Recruiting |
The EUROSCA Natural History Study |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Scale for the assessment and rating of ataxia (SARA)
- Disease stages
- Inventory of non-ataxia signs (INAS)
- (and 3 more...)
|
400 |
All |
18 Years and older (Adult, Senior) |
NCT02440763 |
010/05 |
EUROSCA-NHS |
July 2005 |
July 2050 |
July 2050 |
May 12, 2015 |
June 29, 2017 |
|
- Department of Neurology, Medical University, Innsbruck
Innsbruck, Austria - Université Libre de Bruxelles (ULB), Neurology Service - ULB Hôpital Erasme, ULB Laboratory of Experimental Neurology
Brussels, Belgium - Hôpital de la Pitié-Salpêtrière, Département de Génétique
Paris, France - (and 13 more...)
|
| 30 |
NCT02889302 |
Active, not recruiting |
An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
- Spinocerebellar Degeneration
|
- Drug: KPS-0373
- Drug: Placebo
|
Interventional |
Phase 3 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
|
- SARA (Scale for the Assessment and Rating of Ataxia)
- SF-8(QOL)
|
|
All |
20 Years and older (Adult, Senior) |
NCT02889302 |
KPS1305 |
|
|
November 2018 |
|
September 5, 2016 |
November 17, 2017 |
|
- Multiple Locations, Japan
|
| 31 |
NCT01983631 |
Completed |
The Effect of Whole Body Vibration Training on Neuromuscular Property in Individuals With Ataxia |
|
- Other: Whole body vibration training
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Muscle twitch force
- Muscle voluntary activity level
- Balance
- Severity of cerebellar ataxia
|
17 |
All |
20 Years and older (Adult, Senior) |
NCT01983631 |
100-1184B |
|
April 2011 |
March 2013 |
March 2013 |
November 14, 2013 |
November 14, 2013 |
|
- Chang Gung University
Taoyuan, Taiwan
|
| 32 |
NCT02874911 |
Completed |
Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias |
|
|
Interventional |
Not Applicable |
- University Hospital Tuebingen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Gait
- Stance
- Sitting
- (and 7 more...)
|
10 |
All |
5 Years to 30 Years (Child, Adult) |
NCT02874911 |
Move'n Fun |
Move'n Fun |
September 2012 |
September 2014 |
March 2016 |
August 22, 2016 |
August 22, 2016 |
|
|
| 33 |
NCT02867969 |
Recruiting |
Slowing Down Disease Progression in Premanifest SCA: a Piloting Interventional Exergame Trial |
|
|
Interventional |
Not Applicable |
- University Hospital Tuebingen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Gait score
- Brain networks captured
- Quantitative movement parameters
- (and 3 more...)
|
26 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02867969 |
SlowSCA |
SlowSCA |
August 2016 |
February 2017 |
May 2017 |
August 16, 2016 |
August 16, 2016 |
|
- University Hospital
Tuebingen, Baden-Württemberg, Germany
|
| 34 |
NCT02175290 |
Recruiting |
Machado-Joseph Disease in Israel |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- clinical phenotype of SCA3 Yemenite Jews patients
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02175290 |
MMC140006CTIL |
|
June 2014 |
June 2017 |
June 2018 |
June 26, 2014 |
March 16, 2017 |
|
- Department of Neurology, Meir Medical Center
Kfar-saba, Israel
|
| 35 |
NCT01470729 |
Completed |
Biomarkers in Autosomal Dominant Cerebellar Ataxia |
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- Spinocerebellar Ataxia, Autosomal Recessive 3
- Episodic Ataxia, Type 7
|
- Other: metabolic and imaging biomarkers in SCA1,2,3 and 7 patients
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Time Perspective: Prospective
|
- metabolic biomarkers of SCA
- imaging biomarkers of SCA
|
102 |
All |
18 Years and older (Adult, Senior) |
NCT01470729 |
P100125 |
BIOSCA |
November 2011 |
December 2015 |
December 2015 |
November 11, 2011 |
December 16, 2015 |
|
- Groupe Hospitalier Pitié Salpêtrière
Paris, France
|
| 36 |
NCT03109626 |
Active, not recruiting |
Docosahexaenoic Acid (DHA) Replacement for Treatment in Spinocerebellar Ataxia 38 |
|
|
Interventional |
Not Applicable |
- Barbara Borroni
- Azienda Ospedaliera Spedali Civili di Brescia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline SARA score at 16 weeks and 40 weeks
- Change from Baseline ICARS score at 16 weeks and 40 weeks
- Brain FDG-PET
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03109626 |
CE NP1821 |
SCA38DHA |
June 17, 2015 |
September 17, 2015 |
August 30, 2018 |
April 12, 2017 |
May 22, 2017 |
|
- AO Spedali Civili
Brescia, BS, Italy
|
| 37 |
NCT02540655 |
Recruiting |
Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia |
|
- Biological: Stemchymal®
- Procedure: Excipients
|
Interventional |
Phase 2 |
- Steminent Biotherapeutics Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- To assess the changes from the baseline to all visits on Scale for the Assessment and Rating of Ataxia (SARA) score.
- To assess the safety by incidence of adverse events, changes of vital signs, blood biochemistry tests, complete blood count, immunoactivity assay, urinalysis and magnetic resonance imaging (MRI).
- To assess the changes from the baseline to all visits on SCA functional index (SCAFI)
- (and 4 more...)
|
60 |
All |
20 Years to 70 Years (Adult, Senior) |
NCT02540655 |
IB02 |
|
September 2015 |
November 2017 |
February 2018 |
September 4, 2015 |
November 1, 2016 |
|
- Taipei Veterans General Hospital
Taipei, Taiwan
|
| 38 |
NCT02147886 |
Completed |
Study To Assess Safety, Tolerability and Efficacy of Intravenous Cabaletta in Patients With Machado-Joseph Disease |
- Machado-Joseph Disease / Spinocerebellar Ataxia 3
|
- Drug: Cabaletta for IV infusion once weekly during 24 weeks
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Adverse events
- Physical examination
- Vital signs
- (and 3 more...)
|
15 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02147886 |
BB-MJD-201 |
|
July 2014 |
October 2016 |
November 2016 |
May 28, 2014 |
November 22, 2016 |
|
- Meir Medical Center
Kfar Saba, Israel
|
| 39 |
NCT00004306 |
Completed |
Clinical and Molecular Correlations in Spinocerebellar Ataxia Type 10 (SCA10) |
|
|
Observational |
|
- Office of Rare Diseases (ORD)
- The University of Texas Medical Branch, Galveston
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
18 |
All |
3 Years and older (Child, Adult, Senior) |
NCT00004306 |
199/11796 |
|
November 1999 |
March 2009 |
March 2009 |
October 19, 1999 |
March 6, 2012 |
|
- University of Texas Medical Branch at Galveston
Galveston, Texas, United States
|
| 40 |
NCT00034242 |
Completed |
High-Dose Intravenous Immunoglobulin to Treat Cerebellar Degeneration |
- Spinocerebellar Degenerations
|
- Drug: high-dose intravenous immunoglobulin (IVIG)
|
Interventional |
Phase 2 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
20 |
All |
Child, Adult, Senior |
NCT00034242 |
020185
02-N-0185 |
|
April 2002 |
|
February 2004 |
April 24, 2002 |
March 4, 2008 |
|
- National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
|
| 41 |
NCT01983670 |
Completed |
The Investigation of the Pre-movement Facilitation of Agonist-antagonist Muscles and the Effect of the Feedforward Rehabilitation in Individuals With Hypermetria |
- Spinocerebellar Atrophy (SCA)
|
- Other: Temporal electrical stimulation
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Muscle evoked potential(MEP)
- Electromyography(EMG)
- Movement error
|
40 |
All |
20 Years and older (Adult, Senior) |
NCT01983670 |
98-0951B |
|
July 2009 |
June 2012 |
June 2012 |
November 14, 2013 |
November 14, 2013 |
|
- Chang Gung University
Taoyuan, Taiwan
|
| 42 |
NCT01384435 |
Completed |
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD) |
|
- Drug: KPS-0373
- Drug: Placebo
|
Interventional |
Phase 2 |
- Kissei Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change from baseline in Scale for the assessment and rating of ataxia (SARA)
- Change from baseline in patient improvement impression of activities of daily living
|
200 |
All |
20 Years and older (Adult, Senior) |
NCT01384435 |
KPS1203 |
|
|
|
|
June 29, 2011 |
December 3, 2012 |
|
- Japan
Tokyo and Other Japanese City, Japan
|
| 43 |
NCT02179333 |
Completed |
Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND) |
- Spinocerebellar Ataxia - All Sub-types
- Friedreich's Ataxia
|
- Other: Ataxia rating scale
|
Observational |
|
- University of South Florida
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Inter- and intra-rater agreement
|
30 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02179333 |
STAND2012 |
STAND |
October 2012 |
June 2016 |
|
July 1, 2014 |
June 29, 2016 |
|
- University of South Florida
Tampa, Florida, United States
|
| 44 |
NCT03408080 |
Active, not recruiting |
An Open Pilot Trial of BHV-4157 |
- Spinocerebellar Ataxias
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- (and 3 more...)
|
|
Interventional |
Phase 3 |
- University of California, Los Angeles
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scale for the Assessment and Rating of Ataxia
- 8-Meter Walk Test
- Sheehan Suicidality Tracking Scale
- (and 2 more...)
|
24 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03408080 |
17-001508 |
|
December 15, 2017 |
May 2018 |
January 2019 |
January 23, 2018 |
January 24, 2018 |
|
- University of California, Los Angeles
Los Angeles, California, United States
|
| 45 |
NCT03120013 |
Active, not recruiting |
Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia |
- Ataxia, Cerebellar
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- (and 8 more...)
|
- Device: Anodal cerebellar and cathodal spinal tDCS
- Device: Sham cerebellar and sham spinal tDCS
|
Interventional |
Not Applicable |
- Azienda Ospedaliera Spedali Civili di Brescia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in the ICARS score from baseline
- Change in the SARA score from baseline
- Change in the 9HPT score from baseline
- (and 2 more...)
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT03120013 |
NP1576 |
CStDCSAtaxia |
February 6, 2017 |
December 1, 2018 |
December 23, 2018 |
April 19, 2017 |
September 6, 2017 |
|
- AO Spedali Civili
Brescia, BS, Italy
|
| 46 |
NCT01793168 |
Recruiting |
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford |
- Rare Disorders
- Undiagnosed Disorders
- Disorders of Unknown Prevalence
- (and 260 more...)
|
|
Observational |
|
- Sanford Health
- National Ataxia Foundation
- International WAGR Syndrome Association
- (and 23 more...)
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- To accelerate research into rare disorders by connecting individuals who are interested in research and who have been diagnosed with a rare disorder (or a disorder of unknown prevalence, or who are undiagnosed) with researchers who study rare diseases.
|
20000 |
All |
Child, Adult, Senior |
NCT01793168 |
03-10-014
Hypersomnia Foundation
National Ataxia Foundation
4p- Support Group
CdLS Foundation
Hyperacusis Research Limited
Kabuki Syndrome Network
Kawasaki Disease Foundation
Klippel-Feil Syndrome Freedom
Leiomyosarcoma Direct Research
MSS Support Group
ML4 Foundation
Stickler Involved People
IWSA
Soft Bones
PWN4PWN
aHUS
Klippel-Feil Syndrome Alliance
American MEN Support
Kleine-Levin Syndrome
All Things Kabuki
WSS Foundation
BIVA
ABDA
PROS Foundation (HLH) |
CoRDS |
July 2010 |
December 2100 |
December 2100 |
February 15, 2013 |
October 2, 2017 |
|
- Sanford Health
Sioux Falls, South Dakota, United States
|
| 47 |
NCT02039206 |
Completed |
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease |
- Machado Joseph Disease (SCA3)
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Scale for the Assessment and Rating of Ataxia (SARA)
|
20 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02039206 |
MJD MEIR dTMS
0059-13-MMC |
|
February 2014 |
February 2015 |
June 2016 |
January 17, 2014 |
January 25, 2018 |
|
- Meir Medical Center
Kfar Saba, Israel
|
| 48 |
NCT00957216 |
Completed |
Coenzyme Q10 in Adult-Onset Ataxia |
|
- Drug: Placebo (sugar pill)
- Drug: Coenzyme Q10
|
Interventional |
Phase 1 |
- The University of Texas Medical Branch, Galveston
- University of Florida
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Supportive Care
|
- Measure cerebellar functions by a validated scale (SARA)
|
1 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00957216 |
08-129
08-SAOA-001 |
CoQATAX |
April 2008 |
August 2009 |
August 2009 |
August 12, 2009 |
April 16, 2010 |
|
- The Universtity of Texas, Galveston
Galveston, Texas, United States
|
| 49 |
NCT01104649 |
Completed |
Efficacy of Riluzole in Hereditary Cerebellar Ataxia |
|
- Drug: riluzole
- Drug: Placebo comparator
|
Interventional |
Phase 2
Phase 3 |
- S. Andrea Hospital
- Agenzia Italiana del Farmaco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Scale for the assessment and rating of ataxia (SARA)
- Baropodometric parameters
- Quality of life
- Depression
|
60 |
All |
14 Years to 70 Years (Child, Adult, Senior) |
NCT01104649 |
FARM7KAJM7 |
|
April 2010 |
February 2014 |
March 2014 |
April 15, 2010 |
April 21, 2015 |
|
- Center for Experimental Neurological Therapies (CENTERS), S. Andrea Hospital, II Faculty of Medicine, "Sapienza" University of Rome
Rome, Italy
|
| 50 |
NCT01488461 |
Completed |
Phenotypic and Genotypic Studies in Congenital and Early Onset Ataxias |
- Congenital Cerebellar Ataxias
- Early-onset Cerebellar Ataxias
|
|
Observational |
|
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Observational Model: Family-Based
|
- Percentage of the patients with a mutation in one of the analysed genes.
- Percentage of patients with severe/moderate/mild/absent intellectual deficiency
- Percentage of patients with/without epilepsy/spasticity/extraneurological features and nature and frequency of MRI anomalies
|
165 |
All |
Child, Adult, Senior |
NCT01488461 |
NI 08034
AOM 09178 |
ATAXIC |
January 2012 |
October 2014 |
October 2014 |
December 8, 2011 |
June 15, 2015 |
|
- Hôpital Trousseau, Service de Génétique
Paris, France
|
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