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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts 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; - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), then Placebo 		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.
  • Drug: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
    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.
    Other names:
    • Nuedexta
  • Drug: Placebo
    Placebo once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
Placebo Comparator
Placebo, then Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) 		Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
  • Drug: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)
    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.
    Other names:
    • Nuedexta
  • Drug: Placebo
    Placebo once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.