NCT00582673

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
31

participants targeted

Target at P25-P50 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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

December 21, 2007

Last Update Submit

May 13, 2010

Conditions

Parkinson's Disease

Keywords

Parkinson's, L-dopa, dyskinesia

Outcome Measures

Primary Outcomes (1)

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

    throughout the study

Secondary Outcomes (1)

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

    throughout the study

Study Arms (2)

1

EXPERIMENTAL
Drug: AFQ056

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AFQ056DRUG
1
PlaceboDRUG
2

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
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigator Site

Dresden, Germany

Location

Novartis Investigator Site

Kassel, Germany

Location

Novartis Investigator Site

Leun, Germany

Location

Novartis Investigator Site

Marburg, Germany

Location

Novartis Investigator 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

    Novartis investigative site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

DE(5)