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

Huntington's Disease Clinical Trial

Official title:

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Titration Proof of Concept Study in Patients With Huntington's Disease to Assess the Efficacy, Safety and Tolerability of AFQ056 in Reducing Chorea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01019473
• Other study ID #: CAFQ056A2207
• Secondary ID: 2009-011743-39
• Status: Terminated
• Phase: Phase 2
• First received: November 19, 2009
• Last updated: September 22, 2011
• Start date: November 2009

Study information

• Verified date: September 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

• patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chorea
• Huntington Disease
• Huntington's Disease

Intervention

Drug:
• AFQ056

• Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator Site	Bochum
Germany	Novartis Investigator Site	Munster
Germany	Novartis Investigator Site	Taufkirchen
Germany	Novartis Investigator Site	Tubingen
Germany	Novartis Investigator Site	Ulm
United Kingdom	Novartis Investigator Site	Birmingham
United Kingdom	Novartis Investigator Site	Cardiff
United Kingdom	Novartis Investigator Site	Manchester
United Kingdom	Novartis Investigator Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.		Day 1 to day 46	No
Secondary	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	No