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Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

NCT01491529 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2020-12-23

No results posted yet for this study

Summary

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)

Conditions

  • Dyskinesias
  • Parkinson Disease
  • Movement Disorders
  • Parkinsonian Disorders
  • Anti-Dyskinesia Agents

Interventions

DRUG

AFQ056

AFQ056 will be supplied as oral modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. 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.)

DRUG

Placebo

Placebo for AFQ056 will be supplied as oral tablets.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491529 on ClinicalTrials.gov