Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
1 other identifier
interventional
506
1 country
31
Brief Summary
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2004
CompletedFirst Submitted
Initial submission to the registry
March 15, 2005
CompletedFirst Posted
Study publicly available on registry
March 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2006
CompletedResults Posted
Study results publicly available
July 26, 2018
CompletedJuly 26, 2018
July 1, 2018
1.4 years
March 15, 2005
October 2, 2017
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Week 12
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Week 24
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.
Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.
Baseline, Week 24
Study Arms (2)
Sarizotan
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- The subject is an out-patient.
- The subject presents with a diagnosis of idiopathic Parkinson's disease.
- Prior therapy with all registered Parkinsonian medication is allowed.
You may not qualify if:
- (For female subjects) The subject is pregnant or lactating.
- The subject is participating in another clinical study or has done so within the past 30 days.
- The subject has received neurosurgical intervention related to PD.
- The subject has relevant renal impairment.
- The subject has relevant hepatic impairment.
- The subject is suffering from any dementia or psychiatric illness.
- The subject has a history of allergic asthma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (31)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Oxnard, California, 93030, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
Danbury, Connecticut, 06810, United States
Unknown Facility
Farmington, Connecticut, 06030-1840, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Maitland, Florida, 32751, United States
Unknown Facility
St. Petersburg, Florida, 33703, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Chicago, Illinois, 60611-3078, United States
Unknown Facility
Springfield, Illinois, 62702, United States
Unknown Facility
Des Moines, Iowa, 50309, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Scarborough, Maine, 04074, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Southfield, Michigan, 48034, United States
Unknown Facility
Edison, New Jersey, 08818, United States
Unknown Facility
New Hyde Park, New York, 11040, United States
Unknown Facility
New Hyde Park, New York, 12401, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Brentwood, Tennessee, 37027, United States
Unknown Facility
South Ogden, Utah, 84403, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Milwaukee, Wisconsin, 53233, United States
Related Publications (1)
Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.
PMID: 18175337RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Serono, a division of Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2005
First Posted
March 16, 2005
Study Start
September 30, 2004
Primary Completion
February 28, 2006
Study Completion
February 28, 2006
Last Updated
July 26, 2018
Results First Posted
July 26, 2018
Record last verified: 2018-07