Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease, Dyskinesia

Intervention / Treatment
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* Drug: Sarizotan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: (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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12. | Drug: Placebo<br>* Placebo matching to sarizotan will be administered twice daily.<br>|
| Experimental: Sarizotan 2 milligrams per day (mg/day)<br>Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12. | Drug: Sarizotan<br>* Sarizotan will be administered twice daily.<br>|
| Experimental: Sarizotan 4 mg/day<br>Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12. | Drug: Sarizotan<br>* Sarizotan will be administered twice daily.<br>|
| Experimental: Sarizotan 10 mg/day<br>Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12. | Drug: Sarizotan<br>* Sarizotan will be administered twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12 | Modified AIMS was a 7-item investigator-assessed scale to assess severity of dyskinesia. Each item was rated on a 0 (none) to 4 (severe) scale. Modified AIMS score was sum of the all item scores and ranged from 0 to 28, where higher score indicated increased severity. Modified AIMS score in resting state as well as with activity is reported. | Baseline, Week 12 | 
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12 | 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. | Baseline, Week 12 | 
| Change From Baseline in UPDRS Part III Total Score at Week 12 | The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. UPDRS Part III total score was the sum of the 27 answers (rated on 0 to 4-point scale) related to motor examination, and ranged from 0-108. Higher scores indicated worse motor function. Change from baseline in UPDRS Part III total score, assessed during on-time (time when the participant has no parkinsonian symptoms) as well as off-time (time when the patient experiences increased parkinsonian symptoms), is reported. | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Dyskinesia, Dyskinesia associated with dopaminergic treatment