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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease; Dyskinesia

Treatments: Drug: Placebo; Drug: Sarizotan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00105521

EMR 62225-019

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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398 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.

Treatment:

Drug: Placebo

Sarizotan 2 milligrams per day (mg/day)

Experimental group

Description:

Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.

Treatment:

Drug: Sarizotan

Sarizotan 4 mg/day

Experimental group

Description:

Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.

Treatment:

Drug: Sarizotan

Sarizotan 10 mg/day

Experimental group

Description:

Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.

Treatment:

Drug: Sarizotan