| Primary | Irritability as Assessed by The Irritability Scale. | The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Primary | Irritability as Assessed by The Irritability Scale | The Irritability Scale total score ranges from 0 to 42, with higher scores indicating greater irritability. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Behavioral Symptoms, as Assessed by the Hospital Anxiety and Depression Scale (HADS). | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization. |
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| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Severity Score. | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Behavioral Symptoms, as Assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) - Caregiver Distress. | 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. | 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 | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s). - Irritability/Aggression Subscale | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Behavioral Symptoms, as Assessed by the Problem Behaviors Assessment - Short Version (PBA-s) - Irritability/Aggression Subscale | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Motor Symptoms, as Assessed by the Total Motor Score (TMS) From the UHDRS. | The TMS comprises the motor section of the UHDRS, a 31-item subscale that comprehensively evaluates motor aspects of HD. The overall 31 items are each rated from grade 0 (not affected) to grade 4 (most severely affected), resulting in a range of 0-124 points. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Motor Symptoms, as Assessed by the Total Motor Score (TMS) From the UHDRS. | The TMS comprises the motor section of the UHDRS, a 31-item subscale that comprehensively evaluates motor aspects of HD. The overall 31 items are each rated from grade 0 (not affected) to grade 4 (most severely affected), resulting in a range of 0-124 points. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Motor Symptoms, as Assessed by the Total Maximal Chorea (TMC). | The TMC comprises 7 of the 31 items in the TMS, which are related to chorea symptoms. The total TMC score ranges from 0 to 28, with higher scores indicating greater chorea severity. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Motor Symptoms, as Assessed by the Total Maximal Chorea (TMC). | The TMC comprises 7 of the 31 items in the TMS, which are related to chorea symptoms. The total TMC score ranges from 0 to 28, with higher scores indicating greater chorea severity. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Functional Independence, as Assessed by the UHDRS Total Functional Capacity Scale (TFC). | The TFC lists five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. The total TFC score ranges from 0 to 13, with higher scores signifying better functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Functional Independence, as Assessed by the UHDRS Total Functional Capacity Scale (TFC). | The TFC lists five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. The total TFC score ranges from 0 to 13, with higher scores signifying better functioning. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation. | The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual's degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation). | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation | The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual's degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation). | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Behavior. | The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS. | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Number of Participants With Behavioral Suicidal Events, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Behavior. | The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS. | | Posted | | Count of Participants | | Participants | | 4 Weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Cognitive Symptoms, as Assessed by the The Montreal Cognitive Assessment (MoCA). | The MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains with a total possible score of 0 to 30 points; a score of 26 or above is considered normal for the general population. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Cognitive Symptoms, as Assessed by the The Montreal Cognitive Assessment (MoCA). | The MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains with a total possible score of 0 to 30 points; a score of 26 or above is considered normal for the general population. | | Posted | | Mean | Standard Deviation | score on a scale | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Patient Progress and Treatment Response Over Time, as Assessed by the Clinical Global Impressions Severity Scale (CGI-S). | The CGI is a stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | All Study Participants Pre-Randomization | All Study Participants Pre-Randomization |
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| Secondary | Patient Progress and Treatment Response Over Time, as Assessed by the Clinical Global Impressions Severity Scale (CGI-S). | The CGI is a stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI is a 3-item observer-rated scale that measures illness severity (CGI-S), global improvement or change (CGI-I) and therapeutic response. The scale ranges from 1-7, with higher scores indicating worse outcomes. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Patient Progress and Treatment Response Over Time, as Assessed by the Clinical Global Impressions Improvement Scale (CGI-I). | The CGI is a stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Cognitive Symptoms, as Assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - Cognitive Domain. | The UHDRS - cognitive function assessment a phonetic verbal fluency test, the Symbol Digit Modalities Test, and the Stroop Interference Test. These tests do not have a predefined score range, but higher scores indicate better cognitive performance. | Data were not collected for this outcome measure | Posted | | | | | | Baseline | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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| Secondary | Cognitive Symptoms, as Assessed by the Unified Huntington's Disease Rating Scale (UHDRS) - Cognitive Domain. | The UHDRS - cognitive function assessment a phonetic verbal fluency test, the Symbol Digit Modalities Test, and the Stroop Interference Test. These tests do not have a predefined score range, but higher scores indicate better cognitive performance. | Data were not collected for this outcome measure | Posted | | | | | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Dextromethorphan/Quinidine 20mg/10mg (DM/Q 20mg/10mg) | 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. | | OG001 | Placebo | Placebo one capsule once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days. |
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