Clinical Trial Details

Overview

Research Study Summary

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

Purpose

The aim of this clinical study is to investigate the efficacy and safety of laquinimod as a potential treatment for patients with Huntington’s disease. This study is being conducted to determine if laquinimod helps with the signs and symptoms of Huntington’s disease after 12 months of treatment.

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CW ID: 213450
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
21 to 55 Years
Overall Status
Recruiting
Lead Sponsor
Teva
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Positive genetic testing for HD, or a clinical diagnosis of symptomatic HD (Diagnostic Confidence Level 4)
  • Presence of 36-49 CAG repeats, inclusive, in the huntingtin gene based on centralized CAG testing during screening
  • Male or female between 21-55 years of age, inclusive, with an onset of HD at or after 18 years of age
  • A sum of >5 points on the UHDRS-TMS at the screening visit
  • UHDRS-TFC ≥ 8 at the screening visit
  • Ambulatory, being able to travel to the study center, and judged by the investigator as likely to be able to continue to travel for the duration of the study
  • Availability and willingness of a caregiver, informant, or family member to provide input at study visits assessing CIBIC-Plus, CDR-SB, PBA-s and HD-QoL

Exclusion Criteria:

  • Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azathioprine within 12 months prior to screening
  • Previous use of laquinimod
  • Pregnant or breastfeeding
  • Subjects with a clinically significant or unstable medical or surgical condition

Contact

Kelly Elliott
University of South Florida -Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: 813-974-6022

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