Efficacy, Safety and Tolerability of AFQ056 in Patients With Huntington's Disease in Reducing Chorea

NCT ID: NCT01019473

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington's Disease Chorea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AFQ056A

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AFQ056

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Berlin, , Germany

Site Status

Novartis Investigator Site

Bochum, , Germany

Site Status

Novartis Investigator Site

Münster, , Germany

Site Status

Novartis Investigator Site

Taufkirchen, , Germany

Site Status

Novartis Investigator Site

Tübingen, , Germany

Site Status

Novartis Investigator Site

Ulm, , Germany

Site Status

Novartis Investigator Site

Birmingham, , United Kingdom

Site Status

Novartis Investigator Site

Cardiff, , United Kingdom

Site Status

Novartis Investigator Site

Manchester, , United Kingdom

Site Status

Novartis Investigator Site

Oxford, , United Kingdom

Site Status

Countries

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Germany United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25689146 (View on PubMed)

Other Identifiers

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2009-011743-39

Identifier Type: -

Identifier Source: secondary_id

CAFQ056A2207

Identifier Type: -

Identifier Source: org_study_id