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A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod

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

NCT02215616•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the efficacy of laquinimod as treatment in participants with HD after 52 weeks using the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS or TMS).

Eligibility

Age

21 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documentation of prior positive genetic testing for HD, or a clinical diagnosis of symptomatic HD.
•Presence of 36-49 cytosine-adenosine-guanine (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.
•Women of child-bearing potential (women who are not post menopausal or who have undergone surgical sterilization) must practice an acceptable method of birth control for 30 days before taking the study treatment, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment was administered.
•A sum of greater than (\>) 5 points on the UHDRS-TMS at the screening visit.
•Able and willing to provide written informed consent prior to any study related procedure being performed at the screening visit. Participants with a legal guardian should be consented according to local requirements.
•Willing to provide a blood sample for genomic CAG analysis at the screening visit.
•Willing and able to take oral medication and able to comply with the study specific procedures.
•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 Clinician's Interview-Based Impression of Change (CIBIC)-Plus, Clinical Dementia Rating - Sum of Boxes (CDR-SB), Problem Behaviors Assessment-Short form (PBA-s) and Huntington's Disease Quality of Life (HD-QoL). A caregiver is recommended to be someone who attends to the participant at least 2 to 3 times per week for at least 3 hours per occasion, and the suitability of the caregiver should be judged by the investigator.
+2 more criteria

Exclusion Criteria

•Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azatioprine within 12 months prior to screening.
•Previous use of laquinimod.
•Use of moderate/strong inhibitors of cytochrome P450 (CYP)3A4 within 2 weeks prior to randomization.
•Use of inducers of CYP3A4 within 2 weeks prior to randomization.
•Pregnant or breastfeeding.
•Participants with a clinically significant or unstable medical or surgical condition that may put the participant at risk when participating in the study or may influence the results of the study or affect the participant's ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests. Such conditions may include:
•* A major cardiovascular event (for example; myocardial infarction, acute coronary syndrome, de-compensated congestive heart failure, pulmonary embolism, coronary revascularization) that occurred prior to randomization.
•* Any acute pulmonary disorder.
•* A central nervous system (CNS) disorder other than HD that may jeopardize the participant's participation in the study, including such disorders that are demonstrated on the baseline MRI (based on local read).
•* A gastrointestinal disorder that may affect the absorption of study medication.
+15 more criteria

Locations (53)

Teva Investigational Site 12566

La Jolla, California, United States

Teva Investigational Site 12565

Los Angeles, California, United States

Teva Investigational Site 12567

San Francisco, California, United States

Teva Investigational Site 12575

Englewood, Colorado, United States

Teva Investigational Site 13490

Tampa, Florida, United States

Teva Investigational Site 13326

Iowa City, Iowa, United States

Teva Investigational Site 12568

Wichita, Kansas, United States

Teva Investigational Site 12574

Baltimore, Maryland, United States

Teva Investigational Site 12571

Golden Valley, Minnesota, United States

Teva Investigational Site 12572

St Louis, Missouri, United States

Key Dates

Start Date

October 28, 2014

Primary Completion Date

June 19, 2018

Completion Date

June 19, 2018

Last Updated

May 4, 2020

Enrollment

352

ACTUAL participants

Conditions

Huntington's Disease

Interventions

Laquinimod

DRUG

Placebo

DRUG

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Huntington's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease