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Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

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Novartis

Status and phase

Completed
Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: AFQ056 with L-dopa
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092065
CAFQ056A2216

Details and patient eligibility

About

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Enrollment

23 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months

Exclusion criteria

  • Surgical treatment for PD
  • Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
  • Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

23 participants in 2 patient groups, including a placebo group

AFQ056 100 mg (Bid)
Experimental group
Treatment:
Drug: AFQ056 with L-dopa
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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