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Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease | Clinical Trials | Clareo Health

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Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease

NCT03854019•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess efficacy and safety of dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) in patients with irritability due to Huntington's disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Verified HD mutation carriers;
•Irritable as diagnosed by the Irritability Scale with a score \> 14;
•Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
•Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study.

Exclusion Criteria

•Hypersensitivity to dextromethorphan (e.g., rash, hives), quinine, mefloquine, quinidine, or dextromethorphan/quinidine with a history of thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome induced by these drugs;
•Pregnant or nursing women;
•Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version);
•Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovarectomy or bilateral tubal ligation) or not at least one year post-menopausal;
•Male not using an acceptable barrier method for contraception;
•Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
•Clinically significant renal (calculated creatinine clearance \< 30 ml/min) or hepatic dysfunction;
•Patients with pre-existing hepatic disease;
•Individuals with a history or complete heart block, QTc prolongation or tornadoes de pointes, or at high risk of complete AV block;
•Family history of congenital QT prolongation;
+12 more criteria

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

August 5, 2019

Primary Completion Date

November 11, 2022

Completion Date

November 11, 2022

Last Updated

January 5, 2024

Enrollment

ACTUAL participants

Conditions

Huntington DiseaseIrritability

Interventions

Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)

DRUG

Placebo

DRUG

Psychological Treatments for Youth With Severe Irritability.

NCT02531893

Irritability

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RECRUITINGNA

Fluoxetine on Emotional Experience (FLEX) Study

NCT07424781

Depression - Major Depressive DisorderIrritability+1 more

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RECRUITINGNA

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 5, 2024Data 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.

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Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease

Inclusion Criteria

Exclusion Criteria

Psychological Treatments for Youth With Severe Irritability.

Fluoxetine on Emotional Experience (FLEX) Study

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