Sarizotan in Participants 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 in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia
1 other identifier
interventional
398
1 country
32
Brief Summary
The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.
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
32 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
March 31, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2006
CompletedResults Posted
Study results publicly available
April 2, 2018
CompletedApril 2, 2018
September 1, 2017
1.5 years
March 15, 2005
September 4, 2017
September 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.
Baseline, Week 12
Secondary Outcomes (3)
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12
Baseline, Week 12
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12
Baseline, Week 12
Change From Baseline in UPDRS Part III Total Score at Week 12
Baseline, Week 12
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Sarizotan 2 milligrams per day (mg/day)
EXPERIMENTALParticipants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Sarizotan 4 mg/day
EXPERIMENTALParticipants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
Sarizotan 10 mg/day
EXPERIMENTALParticipants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Interventions
Eligibility Criteria
You may qualify if:
- The participant is an out-patient
- The participant 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 participants) The participant is pregnant or lactating
- The participant is participating in another clinical study or has done so within the past 30 days
- The participant has received neurosurgical intervention related to Parkinson's disease
- The participant has relevant renal impairment
- The participant has relevant hepatic impairment
- The participant is suffering from any dementia or psychiatric illness
- The participant has a history of allergic asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (32)
Unknown Facility
Phoenix, Arizona, 85004, United States
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Scottsdale, Arizona, 85259, United States
Unknown Facility
Fayetteville, Arkansas, 372703, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Port Charlotte, Florida, 33952, United States
Unknown Facility
St. Petersburg, Florida, 33703, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Chicago, Illinois, 60611-3078, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Hoffman Estates, Illinois, 60194, United States
Unknown Facility
Lexington, Kentucky, 40503, United States
Unknown Facility
Baltimore, Maryland, 21207, United States
Unknown Facility
Columbia, Maryland, 21044, United States
Unknown Facility
Boston, Massachusetts, 02118-2526, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Golden Valley, Minnesota, 55427, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Albany, New York, 12205, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
Toledo, Ohio, 43614-5811, United States
Unknown Facility
Allentown, Pennsylvania, 18103, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Upland, Pennsylvania, 19013, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Charlottesville, Virginia, 22903, United States
Related Publications (2)
Goetz CG, Damier P, Hicking C, Laska E, Muller T, Olanow CW, Rascol O, Russ H. Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Mov Disord. 2007 Jan 15;22(2):179-86. doi: 10.1002/mds.21226.
PMID: 17094088BACKGROUNDGoetz 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: 18175337BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For SAEs, due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.
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., an affiliate of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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
March 31, 2006
Study Completion
March 31, 2006
Last Updated
April 2, 2018
Results First Posted
April 2, 2018
Record last verified: 2017-09