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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02215616
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The primary objective of this study is to assess the efficacy of laquinimod (1.0 mg qd) in patients with HD after 12 months of treatment using the UHDRS-TMS.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Laquinimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Laquinimod 0.5 Drug: Laquinimod
Laquinimod 0.5, 1.0, 1.5 mg

Experimental: Laquinimod 1.0 Drug: Laquinimod
Laquinimod 0.5, 1.0, 1.5 mg

Experimental: Laquinimod 1.5
NOTE- As of January 2016, this arm has been discontinued.
Drug: Laquinimod
Laquinimod 0.5, 1.0, 1.5 mg

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in UHDRS TMS (1.0 mg qd) [ Time Frame: Baseline and Months 1, 3, 6 and 12) ]
    Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS TMS)

Secondary Outcome Measures :
  1. Percent atrophy from baseline in caudate volume in patients treated with laquinimod (1.0 mg qd) [ Time Frame: Baseline and Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documentation of prior positive genetic testing for HD, or a clinical diagnosis of symptomatic HD
  • 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
  • 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 >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. Patients with a legal guardian should be consented according to local requirements
  • Willing to provide a blood sample 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 centre, 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. A caregiver is recommended to be someone who attends to the patient 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
  • For patients taking allowed antidepressant medication, the dosing of medication must have been kept constant for at least 30 days before baseline and must be kept constant during the study

    • Additional criteria may apply, please contact the investigator for more information

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
  • Subjects with a clinically significant or unstable medical or surgical condition that may put the patient at risk when participating in the study or may influence the results of the study or affect the patient's ability to take part in the study, as determined by medical history, physical examinations, ECG, or laboratory tests. Such conditions may include:

    • A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, de-compensated congestive heart failure, pulmonary embolism, coronary revascularization) that occurred during the past 6 months prior to randomization
    • Any acute pulmonary disorder
    • A central nervous system (CNS) disorder other than HD that may jeopardize the subject's participation in the study, including such disorders that are demonstrated on the baseline magnetic resonance imaging (MRI) (based on local read)
    • A gastrointestinal disorder that may affect the absorption of study medication
    • Renal disease
    • Cirrhotic patients with moderate or severe hepatic impairment
    • Known human immunodeficiency virus (HIV) positive status. Patients will undergo an HIV test at screening per local requirements, if applicable
    • Any malignancies, excluding basal cell carcinoma, in the 5 years prior to randomization
  • Any clinically significant, abnormal, screening laboratory result which in the opinion of the investigator, affects the patients' suitability for the study or puts the patient at risk if he/she enters the study
  • Unsuitable for MRI (e.g, claustrophobia, metal implants)
  • Alcohol and/or drug abuse within the 6 months prior to screening, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition Text Revision (DSM IV TR) criteria for substance abuse
  • Patients with active suicidal ideation during the past month as measured by a most severe suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the baseline screening Columbia-Suicide Severity Rating Scale (C-SSRS) or subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) if the attempt or acts were performed within 1 year of screening, or subjects who, in the opinion of the investigator, present a serious risk of suicide
  • Patients with known intracranial neoplasms, vascular malformations, or intracranial hemorrhage
  • Known drug hypersensitivity that would preclude administration of laquinimod or placebo, such as hypersensitivity to mannitol, meglumine or sodium stearyl fumarate
  • Swallowing difficulties that would preclude administration of laquinimod or placebo capsules
  • Treatment with any investigational product within 12 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study.

    - Patients in noninterventional and/or observational studies will not be excluded from participating in this study

  • Treatment with tetrabenazine within 30 days of the study baseline visit
  • Treatment with antipsychotic medication within 30 days of the study baseline visit

    • Additional criteria may apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02215616

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Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc. Identifier: NCT02215616     History of Changes
Other Study ID Numbers: TV5600-CNS-20007
2014-000418-75 ( EudraCT Number )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders