Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Novartis

Status and phase: Completed; Phase 2

Conditions: Drug-induced; Dyskinesias

Treatments: Drug: AQW051; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474421

CAQW051A2209

2011-001092-39 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

Enrollment: 71 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Parkinson's disease
• Patients with dyskinesias for at least 3 months
• Patients with moderate to severe dyskinesias
• Patients on L-dopa treatment for at least 3 years

Exclusion criteria

• Patients with atypical Parkinson's disease
• Patients who have had prior surgery for Parkinson's disease
• Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate
• Patients who received neuroleptics or anti-psychotics within 2 months
• Women of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 3 patient groups, including a placebo group

AQW051 High Dose

Experimental group

Description:

AQW051 high dose daily given orally for 28 days.

Treatment:

Drug: AQW051

Drug: AQW051

AQW051 Low Dose

Experimental group

Description:

AQW051 low dose daily given orally for 28 days.

Treatment:

Drug: AQW051

Drug: AQW051

Placebo

Placebo Comparator group

Description:

Placebo daily given orally for 28 days.

Treatment:

Drug: Placebo