NCT01092065

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

4 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, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 23, 2020

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 22, 2010

Last Update Submit

December 15, 2020

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseDyskinesiaDrug-inducedLevodopaL-dopa

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary

    5 weeks

Secondary Outcomes (5)

  • Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.

    5 weeks

  • Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.

    5 weeks

  • Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.

    5 weeks

  • Change from baseline on patient's dyskinesia, disability caused by dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change.

    5 weeks

  • Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs

    5 weeks

Study Arms (2)

AFQ056 100 mg (Bid)

EXPERIMENTAL
Drug: AFQ056 with L-dopa

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AFQ056 with L-dopaDRUG

hard gelatin capsule to be taken bid for six weeks

AFQ056 100 mg (Bid)
PlaceboDRUG

hard gelatin capsule to be taken bid for six weeks

Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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 (4)

The Parkinsons Institute

Sunnyvale, California, 94085, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center

Kansas City, Kansas, 66160, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

mavoglurantLevodopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

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

March 22, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 23, 2020

Record last verified: 2013-03

Locations

US(4)