Evaluation of the Efficacy and Safety of Modified Release 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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491529

CAFQ056A2223

2011-002074-23 (EudraCT Number)

Details and patient eligibility

About

This study will assess the efficacy and safety of modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Enrollment: 154 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and Females 30-80 years old
• Use of highly effective methods of contraception during study in women of childbearing potential
• Outpatients
• Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria
• Score of >/= 2 on UPDRS items 32 and 33
• Dyskinesias for at least 3 months before baseline
• On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline
• Demonstrate capacity to complete accurate diary ratings
• Patients who have a primary caregiver willing to assess the condition of the patient throughout the study in accordance with protocol requirements
• Group 2 only: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study

Exclusion criteria

• Atypical/secondary form of Parkinson's disease
• History of surgical treatment of PD, including deep brain stimulation
• A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
• Advanced, severe, or unstable disease other than PD
• Evidence of dementia
• Treatment with certain prohibited medications
• Amantadine within 2 weeks prior to BL1 visit (applies to Group 1 only)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 3 patient groups, including a placebo group

AFQ056 150 mg

Experimental group

Description:

Patients randomized to the AFQ056 150 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 150 mg twice daily.

Treatment:

Drug: AFQ056

AFQ056 200 mg

Experimental group

Description:

Patients randomized to the AFQ056 200 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 200 mg twice daily. Patients will be randomized in two groups by amantadine status. * Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit. * Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.)

Treatment:

Drug: AFQ056

Placebo

Placebo Comparator group

Description:

Patients randomized to the Placebo arm will receive oral AFQ056 Placebo twice daily

Treatment:

Drug: Placebo