Huntington’s Disease Trial of Laquinimod (LEGATO-HD)

  • Study Director: Michael Geschwind, MD, PhD
  • Sponsor: Teva Branded Pharmaceutical Products R&D, Inc
  • Recruiting? Yes
  • Official Study Title: A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5 and 1.0 mg/day) as Treatment in Patients with Huntington's Disease
  • ClinicalTrials.gov Identifier: NCT02215616
  • Conditions Studied: Huntington’s disease (HD)
  • Intervention: Laquinimod (doses of 0.5 and 1.0 milligrams) and placebo control. Study drug (laquinimod or placebo) is an oral drug taken daily.
  • Phase: Phase 2
  • Duration of Participation: Approximately 14 months

Purpose of the Study

Laquinimod is hypothesized to decrease inflammatory processes that occur in the brain in Huntington’s disease. The purpose of the study is to evaluate the efficacy, safety and tolerability of laquinimod, and the primary endpoint is a change from baseline in the Unified Huntington’s Disease Rating Scale-Total Motor Scale (UHDRS-TMS) as defined by the sum of the scores of all UHDRS-TMS sub-items after 12 months of treatment.

Eligibility

Inclusion Criteria: 

  • Between the ages of 21 and 55 years old (inclusive)
  • Previous genetic testing for HD indicating 40 to 49 CAG repeats in the huntingtin gene
  • Unified Huntington’s Disease Rating Scale Total Motor Score (UHDRS-TMS) of >5 (very mild or greater motor symptoms)
  • Unified Huntington’s Disease Rating Scale Total Functional Capacity (UHDRS-TFC) of ≥8 (relatively independent function)
  • Reliable caregiver who has at least a few hours of contact with subject 2–3 times per week and is willing to attend study visits

Exclusion Criteria: 

  • Treatment with antipsychotic medication or tetrabenazine within 30 days of screening
  • Treatment with investigational product within 12 weeks of screening
  • Alcohol or drug abuse within 12 months prior to screening
  • Pregnant or breastfeeding
  • Unable to have brain MRIs

What to Expect

Testing: Brain MRIs, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood specimen collection, vital signs, telephone calls

The Frequency of Visits:

  • One screening visit
  • Six visits over the course of 12 months on study treatment
  • One follow-up visit, 4 weeks after the end of the study treatment period

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and subjects will receive $45 per visit and travel expenses will be reimbursed, after applicable receipts are provided to UCSF.

Contact Information

Coordinator: Divya Krishnakumar – Divya.Krishnakumar@ucsf.edu, 415.476.2909