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COMPLETEDPHASE1

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

A Multi-Site, Prospective, Longitudinal, Cohort Study Measuring Cerebrospinal Fluid-Mutant Huntingtin Protein in Patients With Huntington's Disease

NCT03664804•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's Disease (HD).

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capacity to consent to participate in the study as assessed using the Evaluation to Sign Consent tool and investigator judgment
•Age 25 to 65 years, inclusive, at the time of signing Informed Consent Form
•Early manifest, Stage I or Stage II HD (defined as TFC of 7-13, inclusive)
•Genetically confirmed disease (CAG repeat length ≥ 36 in huntingtin gene by direct DNA testing)
•Body mass index ≥18 and ≤32 kg/m2; total body weight \>50 kg
•Ability to undergo and tolerate MRI scans
•Ability to tolerate blood draws and lumbar puncture
•Ability and willingness to comply with all aspects of the protocol, including completion of interviews and questionnaires and carrying/wearing of a digital monitoring device
•Stable medical, psychiatric, and neurological status for at least 12 weeks prior to screening and at the time of enrollment
•Signed study companion consent for participation, if a study companion is available
+1 more criteria

Exclusion Criteria

•Any condition, including severe chorea, that would prevent either writing or performing pen and paper or smartphone-based tasks
•History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening
•Current active psychosis, confusional state, or violent behavior
•Any serious medical condition or clinically significant laboratory, vital sign, or electrocardiogram abnormalities at screening that, in the investigator's judgement, precludes the participant's safe participation in and completion of the study
•Pregnant or breastfeeding, or intending to become pregnant during the study
•Positive for hepatitis C virus antibody or hepatitis B surface antigen at screening
•Known HIV infection
•Current or previous use of an antisense oligonucleotide (including small interfering RNA)
•Current use of antipsychotics prescribed for psychosis, cholinesterase inhibitors, memantine, amantadine, or riluzole including use within 12 weeks of enrollment
•Treatment with an investigational drug within 30 days prior to screening or 5 half-lives of the investigational drug, whichever is longer
+7 more criteria

Locations (15)

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Georgetown University; Research Division, Psychiatry

Washington D.C., District of Columbia, United States

Hereditary Neurological Disease Centre (HNDC)

Wichita, Kansas, United States

John Hopkins University School of Medicine

Baltimore, Maryland, United States

Columbia University

New York, New York, United States

The University of Texas Health Science Center at Houston; McGovern Medical School

Houston, Texas, United States

The University of British Columbia; The Centre for Huntington Disease

Vancouver, British Columbia, Canada

Centre for Movement Disorders (Neuropharm Consulting Inc.)

Markham, Ontario, Canada

Charité - Universitätsmedizin Berlin, Campus Charité Mitte; Klinik für Psychiatrie und Psychotherapi

Berlin, Germany

St. Josef and St. Elisabeth gGmbH ; St. Josef Hospital Bochum; Neurologisches Forschungszentrum

Bochum, Germany

Key Dates

Start Date

December 5, 2018

Primary Completion Date

May 7, 2021

Completion Date

May 7, 2022

Last Updated

January 3, 2025

Enrollment

ACTUAL participants

Conditions

Huntington's Disease

Interventions

No Study Drug was Administered in this Study

OTHER

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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: January 3, 2025Data 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

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

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)

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

A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease