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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01019473
• Collaborator: (none)
• Enrollment: 44
• Locations: 10
• Arms: 2
• Patients Per Site: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Huntington's Disease; Chorea	Drug: AFQ056; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AFQ056A	Drug: AFQ056
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS. [Day 1 to day 46]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	Berlin		Germany
2	Novartis Investigator Site	Bochum		Germany
3	Novartis Investigator Site	Munster		Germany
4	Novartis Investigator Site	Taufkirchen		Germany
5	Novartis Investigator Site	Tubingen		Germany
6	Novartis Investigator Site	Ulm		Germany
7	Novartis Investigator Site	Birmingham		United Kingdom
8	Novartis Investigator Site	Cardiff		United Kingdom
9	Novartis Investigator Site	Manchester		United Kingdom
10	Novartis Investigator Site	Oxford		United Kingdom

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01019473
• Other Study ID Numbers: CAFQ056A2207; 2009-011743-39
• First Posted: Nov 25, 2009
• Last Update Posted: Sep 23, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Novartis Pharmaceuticals: Huntington's disease; Chorea; Dyskinesia
• Additional relevant MeSH terms: Huntington Disease; Chorea

Study Results

No Results Posted as of Sep 23, 2011