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NMDA receptor antagonist
Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
Phase 3
Waitlist Available
Led By Erin L Furr Stimming, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new drug to see if it helps with irritability in Huntington's disease patients.
Eligible Conditions
- Huntington's Disease
- Irritability
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Irritability as Assessed by The Irritability Scale
Irritability as Assessed by The Irritability Scale.
Secondary study objectives
Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS).
Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress.
Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score.
+12 moreSide effects data
From 2022 Phase 3 trial • 20 Patients • NCT0385401910%
Headaches
5%
Primary care physician (PCP) prescribed medication for high blood pressure
5%
Insomnia
5%
Nausea
5%
Loss weight/decreased appetite
5%
Dizziness
5%
Increased libido
5%
Increased apathy
5%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), then PlaceboExperimental Treatment2 Interventions
Dextromethorphan/quinidine (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.
Group II: Placebo, then Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)Placebo Group2 Interventions
Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
2019
Completed Phase 3
~20
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Cures Within ReachOTHER
23 Previous Clinical Trials
2,139 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,832 Total Patients Enrolled
Erin L Furr Stimming, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston