Sarizotan HC1 in Patients 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

NCT00105508

EMR 62225-018

Details and patient eligibility

About

The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).

Enrollment: 506 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is an out-patient.
• The subject presents with a diagnosis of idiopathic Parkinson's disease.
• Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion criteria

• (For female subjects) The subject is pregnant or lactating.
• The subject is participating in another clinical study or has done so within the past 30 days.
• The subject has received neurosurgical intervention related to PD.
• The subject has relevant renal impairment.
• The subject has relevant hepatic impairment.
• The subject is suffering from any dementia or psychiatric illness.
• The subject has a history of allergic asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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506 participants in 2 patient groups, including a placebo group

Sarizotan

Experimental group

Treatment:

Drug: Sarizotan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo