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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03854019
Date of registration: 22/02/2019
Prospective Registration: Yes
Primary sponsor: The University of Texas Health Science Center, Houston
Public title: Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
Scientific title: Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
Date of first enrolment: August 5, 2019
Target sample size: 22
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03854019
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Erin Furr Stimming, MD
Address: 
Telephone: 713-500-7033
Email: Erin.E.Furr@uth.tmc.edu
Affiliation: 
Name:     Erin Furr Stimming, MD
Address: 
Telephone: (713) 500-7033
Email: Erin.E.Furr@uth.tmc.edu
Affiliation: 
Name:     Erin L Furr Stimming, MD
Address: 
Telephone:
Email:
Affiliation:  The University of Texas Health Science Center, Houston
Key inclusion & exclusion criteria

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;

- History of unexplained syncope within the past year;

- Use of drugs containing quinidine, quinine, or mefloquine;

- Individuals currently taking strong CYP3A4 inhibitors or tetrabenazine;

- Use of certain antidepressants--amitriptyline, clomipramine, desipramine, fluoxetine,
paroxetine, sertraline, venlafaxine;

- Use of certain heart rhythm medications--amiodarone, flecainide, procainamide,
propafenone;

- Use of certain medicines to treat psychiatric disorders--chlorpromazine, haloperidol,
perphenazine, pimozide, quetiapine, risperidone, thioridazine.

- Use of tamoxifen;

- Presence or history of seizures or diagnosed epilepsy;

- Severe cognitive disorders defined as a score < 18 on the MOCA;

- Clinically relevant abnormal findings in the ECG, the vitals, in the physical
examination or laboratory values at screening that could interfere with the objectives
of the study or the safety of the subject as judged by the investigator;

- Participation in another investigative drug trial within 2 months;

- Subjects who are unlikely to be compliant and attend scheduled clinic visits as
required as determined by the Investigator.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Huntington Disease
Irritability
Intervention(s)
Drug: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
Drug: Placebo
Primary Outcome(s)
Irritability as assessed by The Irritability Scale [Time Frame: Week 6.]
Irritability as assessed by The Irritability Scale. [Time Frame: Baseline.]
Irritability as assessed by The Irritability Scale. [Time Frame: Week 13.]
Secondary Outcome(s)
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Behavior. [Time Frame: Baseline.]
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal ideation [Time Frame: Week 6.]
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal ideation. [Time Frame: Baseline.]
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation. [Time Frame: Week 13.]
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). [Time Frame: Week 3.]
Behavioral suicidal events, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). [Time Frame: Week 6.]
Behavioral symptoms, as assessed by the Hospital Anxiety and Depression Scale (HADS). [Time Frame: Baseline.]
Behavioral symptoms, as assessed by the Hospital Anxiety and Depression Scale (HADS). [Time Frame: Week 13.]
Behavioral symptoms, as assessed by the Hospital Anxiety and Depression Scale (HADS). [Time Frame: Week 6.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - caregiver distress. [Time Frame: Baseline.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - caregiver distress. [Time Frame: Week 13.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - caregiver distress. [Time Frame: Week 6.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - severity score. [Time Frame: Baseline.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - severity score. [Time Frame: Week 13.]
Behavioral symptoms, as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - severity score. [Time Frame: Week 6.]
Behavioral symptoms, as assessed by the Problem Behaviors Assessment - short version (PBA-s). [Time Frame: Baseline.]
Behavioral symptoms, as assessed by the Problem Behaviors Assessment - short version (PBA-s). [Time Frame: Week 13.]
Behavioral symptoms, as assessed by the Problem Behaviors Assessment - short version (PBA-s). [Time Frame: Week 6.]
Cognitive symptoms, as assessed by the The Montreal Cognitive Assessment (MoCA). [Time Frame: Baseline.]
Cognitive symptoms, as assessed by the The Montreal Cognitive Assessment (MoCA). [Time Frame: Week 13.]
Cognitive symptoms, as assessed by the The Montreal Cognitive Assessment (MoCA). [Time Frame: Week 6.]
Cognitive symptoms, as assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - cognitive domain. [Time Frame: Baseline.]
Cognitive symptoms, as assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - cognitive domain. [Time Frame: Week 13.]
Cognitive symptoms, as assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - cognitive domain. [Time Frame: Week 6.]
Functional independence, as assessed by the UHDRS Total Functional Capacity Scale (TFC). [Time Frame: Baseline.]
Functional independence, as assessed by the UHDRS Total Functional Capacity Scale (TFC). [Time Frame: Week 13.]
Functional independence, as assessed by the UHDRS Total Functional Capacity Scale (TFC). [Time Frame: Week 6.]
Motor symptoms, as assessed by the total maximal chorea (TMC). [Time Frame: Baseline.]
Motor symptoms, as assessed by the total maximal chorea (TMC). [Time Frame: Week 13.]
Motor symptoms, as assessed by the total maximal chorea (TMC). [Time Frame: Week 6.]
Motor symptoms, as assessed by the total motor score (TMS) from the UHDRS. [Time Frame: Baseline.]
Motor symptoms, as assessed by the total motor score (TMS) from the UHDRS. [Time Frame: Week 13.]
Motor symptoms, as assessed by the total motor score (TMS) from the UHDRS. [Time Frame: Week 6.]
Patient progress and treatment response over time, as assessed by the Clinical Global Impressions Scale (CGI). [Time Frame: Baseline.]
Patient progress and treatment response over time, as assessed by the Clinical Global Impressions Scale (CGI). [Time Frame: Week 13.]
Patient progress and treatment response over time, as assessed by the Clinical Global Impressions Scale (CGI). [Time Frame: Week 6.]
Secondary ID(s)
HSC-MS-18-1049
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Cures Within Reach
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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