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

EMD Serono398 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

398

Conditions

Parkinson's Disease Dyskinesia

Interventions

SarizotanDRUG

Sarizotan will be administered twice daily.

PlaceboDRUG

Placebo matching to sarizotan will be administered twice daily.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (32)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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