NCT00888004

Brief Summary

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

April 23, 2009

Last Update Submit

April 15, 2016

Conditions

Parkinson's DiseaseL-dopa Induced Dyskinesia

Keywords

Parkinson'sL-dopadyskinesia

Outcome Measures

Primary Outcomes (1)

  • Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa

    20 days

Secondary Outcomes (1)

  • Safety and tolerability of administration of AFQ056 in combination with L-dopa

    20 days

Study Arms (2)

Active

EXPERIMENTAL
Drug: AFQ056

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AFQ056DRUG
Active
PlaceboDRUG
Placebo

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Parkinson's Disease
  • Patients with L-dopa induced dyskinesia for at least 3 months
  • Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

You may not qualify if:

  • History of severe allergy to food or drugs
  • Very low or high body weight.
  • Prior surgery for Parkinson's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Dresden, Germany

Location

Novartis Investigative Site

Kassel, Germany

Location

Novartis Investigative Site

Leun-Biskirchen, Germany

Location

Novartis Investigative Site

Marburg, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Related Publications (1)

  • Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.

    PMID: 21484867DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

DE(5)