NCT01173731

Brief Summary

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Oct 2010

Typical duration for phase_2 parkinson-disease

Geographic Reach
6 countries

22 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

First Submitted

Initial submission to the registry

July 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 23, 2020

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

July 28, 2010

Last Update Submit

December 15, 2020

Conditions

Parkinson DiseaseDyskinesia, Drug-InducedLevodopa

Keywords

Parkinson DiseaseL-dopaLevodopaDyskinesiainvoluntary movementmotor complication

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC).

    3.5 years

Secondary Outcomes (2)

  • Assessment of dyskinetic symptoms by change from baseline in mAIMS total score

    3.5 years

  • Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively

    3.5 years

Study Arms (1)

AFQ056

EXPERIMENTAL
Drug: AFQ056

Interventions

AFQ056DRUG
AFQ056

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Novartis Investigative Site

Sunnyvale, California, 94089, United States

Location

Novartis Investigative Site

Englewood, Colorado, 80113, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46202, United States

Location

Novartis Investigative Site

Heidelberg, Victoria, 3081, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

Novartis Investigative Site

Ottawa, Ontario, K1G 4G3, Canada

Location

Novartis Investigative Site

Gatineau, Quebec, J9J 0A5, Canada

Location

Novartis Investigative Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Novartis Investigative Site

Clermont-Ferrand, 63003, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Kassel, 34128, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

München, 80804, Germany

Location

Novartis Investigative Site

Stadtroda, 07646, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Lido di Camaiore, LU, 55041, Italy

Location

Novartis Investigative Site

Roma, RM, 00163, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseDyskinesia, Drug-InducedDyskinesias

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

August 2, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 23, 2020

Record last verified: 2017-03

Locations

AU(3)IT(3)FR(3)CA(3)US(3)DE(7)