A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease

NCT01458470 | Completed Phase 2 DMC

• 1 other identifier: H11-01364
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Huntington disease is characterized by difficulties in movement and thinking. Psychological disturbances including irritability, aggression, loss of interest, depressed mood, obsessions and compulsions, also represent common symptoms of HD. These symptoms are distressing both for HD patients and their caregivers, contribute to the loss of ability to carry out activities of daily living, and present a major treatment challenge for physicians. The goal of this study is to determine the effect of memantine on movement, thinking and emotional difficulties in HD patients. Memantine is a medication originally approved for the treatment of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD), which has also recently been shown to improve the behavioural and neuropathological symptoms in a mouse model of Huntington Disease (HD).

Conditions

Huntington Disease

Keywords

huntington; huntingtin; memantine; ebixa; namenda

Outcome Measures

Primary Outcomes (1)

• Utility of TRACK-HD study endpoints in a clinical trial setting

  To examine the clinical utility of novel trial endpoints (such as Putaminal NAA measured by MRS) developed in the TRACK-HD study in the setting of a placebo-controlled therapeutic trial.

  24 weeks

Secondary Outcomes (1)

• Neuropsychiatric and Cognitive Test Scores

  24 weeks

Study Arms (2)

Memantine

ACTIVE COMPARATOR

NMDA Receptor Antagonist

Drug: Memantine

Sugar pill

PLACEBO COMPARATOR

Other: Placebo

Interventions

Memantine DRUG

oral tablet, 1 BID, 24 weeks

Also known as: Ebixa, DIN 02260638, Namenda

Memantine

Placebo OTHER

oral tablet, 1 BID, 24 weeks

Sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, a subject must be enrolled in the early HD cohort of the TRACK-HD study and:
• be at least 18 years of age and not older than 65
• able to provide written consent
• carry the abnormal HD gene and show early symptoms of HD
• be able and willing to comply with study requirements, including travel to study center
• have no metal implants to be suitable for MRI scans and able to tolerate them
• able to tolerate blood draws
• be of stable medical, psychiatric and neurological health at the time of enrollment
• not have a history of significant head injury
• not have a history of significant hand injury that would prevent either writing or performing rapid computer tasks
• not be abusing drugs and/or alcohol that may cause failure to comply with study procedures
• not be currently participating in PREDICT-HD or a clinical drug trial.

You may not qualify if:

• Prospective subjects will be excluded if:
• they are younger than 18 years of age and older than 65
• they are unable to provide written consent
• they show advanced symptoms of HD if they are HD gene carriers
• they are unwilling to comply with study requirements, including travel to study center
• they are unsuitable for MRI (e.g, claustrophobia, metal implants) or unable to tolerate them
• they are unable to tolerate blood draws; or,
• they have a major psychiatric disorder, concomitant significant neurological disorder or concomitant significant medical illness at the time of enrollment
• they have a history of CNS disease or significant head injury; or,
• they have a history of significant hand injury that would prevent either writing or performing rapid computer tasks; or,
• they are likely to be non-compliant with study procedures due to drug and/or alcohol abuse; or,
• they are participating in PREDICT-HD or a clinical drug trial at the time of enrollment.
• they are not sighted
• English is not their first language
• they are currently or treated within the last 6 months with antipsychotic medications, including the traditional neuroleptics such as haloperidol as well as the atypical antipsychotics risperidone, clozapine, quetiapine and olanzapine

Sponsors & Collaborators

• University of British Columbia: lead
• Huntington Society of Canada: collaborator
• Huntington Study Group: collaborator

Study Sites (1)

The Centre for Huntington Disease

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Links

• The Huntington Study Group
• The Huntington Society of Canada
• Health Canada

MeSH Terms

Conditions

Huntington Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Blair R. Leavitt, MD,CM,FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Michael R. Hayden, MD,ChB,PhD

  The University of British Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medical Genetics

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

CA (1)