Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Novartis

Status and phase: Completed; Phase 2

Conditions: Parkinsonian Disorders; Movement Disorders; Parkinson Disease; Anti-Dyskinesia Agents; Dyskinesias

Treatments: Drug: AFQ056

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491932

2011-004378-27 (EudraCT Number)

CAFQ056A2299

Details and patient eligibility

About

This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

Enrollment: 129 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
• Outpatients
• Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements

Exclusion criteria

• Atypical or secondary form of Parkinson's disease
• History of surgical treatment for PD including deep brain stimulation
• Advanced, severe, or unstable disease (other than PD)
• History of malignancy
• Evidence of dementia
• Untreated/ineffectively treated mental disorders
• Treatment with certain prohibited medications
• Abnormal lab values or heart abnormalities
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

AFQ056

Experimental group

Description:

Patients entering the study will be titrated to target dose of AFQ056 twice daily or the highest tolerated dose at weekly intervals.

Treatment:

Drug: AFQ056