Trial · NCT03854019
Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
NCT03854019, Phase 3, Completed, The University of Texas Health Science Center, Houston; results first posted 2024-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease. Trials, record NCT03854019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03854019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease
- NCT number
- NCT03854019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Huntington Disease, Irritability
- Interventions
- Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg), Placebo
- First posted
- 2019-02-26
- Last updated
- 2024-01-05
- Results first posted
- 2024-01-05
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Irritability as Assessed by The Irritability Scale. | Baseline | The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability. |
| Primary | Irritability as Assessed by The Irritability Scale | 4 weeks | The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability. |
| Secondary | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | Baseline | The HADS is a self-report, 14-item scale (7 items relate to anxiety and 7 relate to depression) used to determine the levels of anxiety and depression that a person is experiencing. The total score ranges from 0 to 42 (21 per subscale), with higher scores signifying worse symptoms. |
| Secondary | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | 4 weeks | The HADS is a self-report, 14-item scale (7 items relate to anxiety and 7 relate to depression) used to determine the levels of anxiety and depression that a person is experiencing. The total score ranges from 0 to 42 (21 per subscale), with higher scores signifying worse symptoms. |
| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | Baseline | The NPI-Q is a 12-domain informant-based interview that assesses neuropsychiatric symptoms over the previous month.The total NPI-Q severity score ranges from 0 to 36, with higher scores indicate greater symptoms severity. |
| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | 4 weeks | The NPI-Q is a 12-domain informant-based interview that assesses neuropsychiatric symptoms over the previous month.The total NPI-Q severity score ranges from 0 to 36, with higher scores indicate greater symptoms severity. |
| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | Baseline | Caregiver distress associated with the symptom is rated on an anchored 0- to 5-point scale, which total sum ranges from 0 to 60. Higher scores indicate greater caregiver distress related to patient's neuropsychiatric symptoms. |
| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | 4 weeks | Caregiver distress associated with the symptom is rated on an anchored 0- to 5-point scale, which total sum ranges from 0 to 60. Higher scores indicate greater caregiver distress related to patient's neuropsychiatric symptoms. |
| Secondary | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s). - Irritability/Aggression Subscale | Baseline | The PBA-s is a semistructured interview to measure severity and frequency of behavioral problems in Huntington's disease. The PBA-s is an 11-item scale rating the frequency and severity of symptoms. The total score for irritability/aggression subscale ranges from 0 to 32, with higher scores indicating greater behavioral symptoms severity. |
| Secondary | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s) - Irritability/Aggression Subscale | 4 weeks | The PBA-s is a semistructured interview to measure severity and frequency of behavioral problems in Huntington's disease. The PBA-s is an 11-item scale rating the frequency and severity of symptoms. The total score for irritability/aggression subscale ranges from 0 to 32, with higher scores indicating greater behavioral symptoms severity. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Irritability as Assessed by The Irritability Scale. | Baseline | score on a scale | MEAN | |
| PRIMARY | Irritability as Assessed by The Irritability Scale | 4 weeks | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | Baseline | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | 4 weeks | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | Baseline | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | 4 weeks | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | Baseline | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | 4 weeks | Data were not collected for 1 participant in the Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) arm. Data were not collected for 1 participant in the Placebo arm | score on a scale | MEAN |
| SECONDARY | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s). - Irritability/Aggression Subscale | Baseline | score on a scale | MEAN | |
| SECONDARY | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s) - Irritability/Aggression Subscale | 4 weeks | score on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Irritability as Assessed by The Irritability Scale. | All Study Participants Pre-Randomization | 27.5 | Standard Deviation 5.8 | score on a scale | |
| Irritability as Assessed by The Irritability Scale | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 18.7 | Standard Deviation 10.1 | score on a scale | |
| Irritability as Assessed by The Irritability Scale | Placebo | 19.9 | Standard Deviation 9.4 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | All Study Participants Pre-Randomization | 16.7 | Standard Deviation 5.6 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 10.6 | Standard Deviation 6.7 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | Placebo | 11.1 | Standard Deviation 8.3 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | All Study Participants Pre-Randomization | 10.4 | Standard Deviation 4.2 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 8.2 | Standard Deviation 4.5 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | Placebo | 8.6 | Standard Deviation 6.2 | score on a scale | |
| Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | All Study Participants Pre-Randomization | 13.1 | Standard Deviation 6.5 | score on a scale |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (4 Weeks) | STARTED | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg), Then Placebo | 10 | |
| First Intervention (4 Weeks) | STARTED | Placebo, Then Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 10 | |
| First Intervention (4 Weeks) | COMPLETED | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg), Then Placebo | 9 | |
| First Intervention (4 Weeks) | COMPLETED | Placebo, Then Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 9 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg), Then Placebo | 1 | |
| First Intervention (4 Weeks) | NOT COMPLETED | Placebo, Then Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 1 | |
| Washout (1 Week) | STARTED | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg), Then Placebo | 9 | |
| Washout (1 Week) | STARTED | Placebo, Then Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 9 | |
| Washout (1 Week) | COMPLETED | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg), Then Placebo | 9 | |
| Washout (1 Week) | COMPLETED | Placebo, Then Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Insomnia | General disorders | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 1 | 20 | |
| other | Insomnia | General disorders | Placebo | 1 | 20 | |
| other | Headaches | General disorders | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 2 | 20 | |
| other | Headaches | General disorders | Placebo | 0 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 0 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 20 | |
| other | Fingernail infection | Infections and infestations | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 0 | 20 | |
| other | Fingernail infection | Infections and infestations | Placebo | 1 | 20 | |
| other | Nausea | General disorders | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 1 | 20 | |
| other | Nausea | General disorders | Placebo | 0 | 20 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 10 | 20 |
| Total, other adverse events | Placebo | 5 | 20 |
| Total, serious adverse events | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 0 | 20 |
| Total, serious adverse events | Placebo | 1 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41499296 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) vs Placebo: Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Behavior. | Trial comparisons |
| Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) vs Placebo: deaths from any cause | Trial comparisons |
Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) vs Placebo: Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation | Trial comparisons |
| Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) vs Placebo: serious adverse events | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03854019
GET https://conductscience.org/api/trials/v1/NCT03854019/registered?page=2