LEGATO-HD is a Phase II clinical research trial that will look at the safety of an investigational drug called laquinimod and how it may affect movement, thinking and behaviour compared to placebo (a sugar pill) in people with Huntington’s disease (HD).

Laquinimod is an investigational drug being studied to see if it may have an effect on some of the symptoms of Huntington’s disease. Laquinimod has already been investigated for the treatment of multiple sclerosis (MS) as it acts both on the immune system and within the central nervous system. It has been suggested that day laquinimod may have an effect on the progression of HD. This trial is being conducted to determine if laquinimod helps with the signs and symptoms of HD.

LEGATO-HD is a joint collaboration between the Huntington Study Group (HSG), the European Huntington’s Disease Network (EHDN) and Teva Branded Pharmaceutical Products R&D Inc.
400 people are expected to take part in the LEGATO-HD Study at approximately 36 trial sites across North America and Europe.

Participants will receive laquinimod or placebo in the form of capsules, for 52 weeks (12 months). The trial will last approximately 14 months, which includes: 1 screening visit, 52 weeks of treatment (including 6 clinic visits and 1 telephone call) and 1 follow-up visit.

Click here for more detailed eligibility information and exclusion criteria.

The LEGATO-HD Study
A randomized, double blind research study to see what effect the investigational drug, laquinimod, has on movement, thinking, and behavior, compared to placebo (a sugar pill), in people with Huntington disease after 52 weeks of receiving either laquinimod or placebo.

What is the LEGATO-HD Study?
The purpose of the LEGATO-HD trial is to see what effect different doses of an investigational drug called laquinimod may have on people with HD. In addition, information will be collected about the safety and possible side effects of laquinimod in people with HD. This is a placebo-controlled trial, with participants randomly assigned to receive one of three different doses of laquinimod, or placebo (sugar pill). Everyone will receive the same number of capsules (3, taken together once a day), and neither participants nor their trial doctors will know to which group they are assigned.

Who is running the LEGATO-HD Trial?
LEGATO-HD is a joint collaboration between the Huntington Study Group (HSG), the European Huntington’s Disease Network (EHDN) and Teva Branded Pharmaceutical Products R&D Inc. 400 people are expected to take part in the LEGATO-HD Study at approximately 36 trial sites across North America and Europe. Participants will receive laquinimod or placebo in the form of capsules, for 52 weeks (12 months).
The trial is sponsored (financially supported) by Teva Branded Pharmaceutical Products R&D Inc.

Who is eligible to participate in the LEGATO -HD trial?
You may be eligible to participate in the study if you meet the following requirements:

• You are between the ages of 18 and 55
• You are able and willing to provide written informed consent prior to any trial-related procedure
• You are willing to provide a blood sample for genetic analyses
• You are willing and able to take medication by mouth and cooperate with trial procedures
• You are able to walk by yourself or with assistance and able to travel to the trial center, and judged by the trial physician as likely to be able to travel for the duration of the trial
• You have a caregiver willing to attend trial visits with you
• You not been treated with chemotherapy or drugs that affect your immune system
• You are not taking tetrabenazine (Xenazine)

How can I learn more about the LEGATO-HD trial?
Visit:www.clinicaltrials.gov