LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD)
Research type
Research Study
Full title
A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease
IRAS ID
151325
Contact name
Sarah Tabrizi
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2014-000418-75
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
Huntington's disease is a hereditary disorder causing degeneration of neurons in the brain leading to uncontrolled movements, progressive loss of controlled motor function, cognitive decline, and emotional disturbance. The onset and progression varies but the most common age of onset is between 30 and 40 years. The illness generally lasts 15-20 years, and has fatal outcome.
The aim of this clinical study is investigate the efficacy and safety of laquinimod as a potential treatment for patients with Huntington’s disease (HD).None of the drugs used today has an effect on disease progression.It is planned to randomize a total of 400 patients (100 patients within each study arm) in aproximately 30 centres. Patients will be treated with investigational product or matching placebo for 12 months, and efficacy and safety will be assessed after 1, 3, 6, 9 and 12 months of treatment and a follow-up period of 1 month after the last dose of study medication for safety reason.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1340
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion