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

Phase 3

Completed

• Conditions: Parkinson's Disease; Dyskinesia
• Interventions: Drug: Placebo; Drug: Sarizotan

• Registration Number: NCT00105521
• Lead Sponsor: EMD Serono

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-30
• Study First Submitted: 2005-03-15
• Study First Submitted QC: 2005-03-15
• Study First Posted: 2005-03-16
• Primary Completion: 2006-03-31
• Study Completion: 2006-03-31
• Status Verified: 2017-09
• Results First Submitted: 2017-09-04
• Results First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-04
• Results First Posted: 2018-04-02
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
Sarizotan 2 milligrams per day (mg/day)	Sarizotan	Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
Sarizotan 10 mg/day	Sarizotan	Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Sarizotan 4 mg/day	Sarizotan	Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12	Baseline, 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.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12	Baseline, 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.
Change From Baseline in UPDRS Part III Total Score at Week 12	Baseline, 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.