CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) +1 moredrug
Likely dose
Dextromethorphan/quinidine 20mg/10mg: one capsule once daily for 1 week, then twice daily for 4 weeks, then once daily for 7 daysAI-extracted
Key inclusion· 3
  • Verified HD mutation carriers
  • Irritability diagnosed by Irritability Scale with score >14
  • Stable concomitant medication with no changes in the last 30 days prior to inclusion
Key exclusion· 17
  • Hypersensitivity to dextromethorphan, quinine, quinidine, mefloquine, or dextromethorphan/quinidine with history of thrombocytopenia, hepatitis, bone marrow depression, or lupus-like syndrome
  • Active suicidality based on Columbia-Suicide Severity Rating Scale responses
  • Uncontrolled medical conditions such as uncontrolled arterial hypertension or diabetes mellitus
  • Clinically significant renal dysfunction with calculated creatinine clearance <30 ml/min or hepatic dysfunction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03854019
NCT03854019Phase 3Completed

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

The University of Texas Health Science Center, Houston·interventional·Posted Feb 26, 2019·Updated Jan 5, 2024

In Brief

A Phase 3 clinical trial evaluating Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) and Placebo for Huntington Disease and Irritability. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCures Within Reach

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 26, 2019
Enrollment StartAug 5, 2019
Primary CompletionNov 11, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.4 years ago

Interventions

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

DM/Q 20mg/10mg one capsule once daily for 1 week, followed by DM/Q 20mg /10 mg twice daily for subsequent 4 weeks, and finally DM/Q 20mg/10mg once daily for 7days.

Placebodrug

Placebo once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.