NCT01019473

Brief Summary

This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.

Trial Health

40
At Risk

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

10 active sites

Status
terminated

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

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

November 19, 2009

Last Update Submit

September 22, 2011

Conditions

Huntington's DiseaseChorea

Keywords

Huntington's diseaseChoreaDyskinesia

Outcome Measures

Primary Outcomes (1)

  • Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.

    Baseline to day 28

Secondary Outcomes (2)

  • Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.

    Day 1 to day 46

  • Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients

    Day 1 to day 46

Study Arms (2)

AFQ056A

EXPERIMENTAL
Drug: AFQ056

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AFQ056DRUG
AFQ056A
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Huntington's disease (based on DNA testing polyQ \>36) with a UHDRS maximal chorea score of \>10
  • patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
  • female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception

You may not qualify if:

  • patients with marked cognitive impairment (MMSE less than 18), with presence of psychosis and/or confusional states

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Bochum, Germany

Location

Novartis Investigator Site

Münster, Germany

Location

Novartis Investigator Site

Taufkirchen, Germany

Location

Novartis Investigator Site

Tübingen, Germany

Location

Novartis Investigator Site

Ulm, Germany

Location

Novartis Investigator Site

Birmingham, United Kingdom

Location

Novartis Investigator Site

Cardiff, United Kingdom

Location

Novartis Investigator Site

Manchester, United Kingdom

Location

Novartis Investigator Site

Oxford, United Kingdom

Location

Related Publications (1)

  • Reilmann R, Rouzade-Dominguez ML, Saft C, Sussmuth SD, Priller J, Rosser A, Rickards H, Schols L, Pezous N, Gasparini F, Johns D, Landwehrmeyer GB, Gomez-Mancilla B. A randomized, placebo-controlled trial of AFQ056 for the treatment of chorea in Huntington's disease. Mov Disord. 2015 Mar;30(3):427-31. doi: 10.1002/mds.26174. Epub 2015 Feb 17.

    PMID: 25689146DERIVED

MeSH Terms

Conditions

Huntington DiseaseChoreaDyskinesias

Interventions

mavoglurant

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental DisordersNeurologic 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

November 19, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Last Updated

September 23, 2011

Record last verified: 2011-09

Locations

DE(6)GB(4)