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The study was terminated prematurely because of difficulty with recruiting.
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Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment.
This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods.
Approximately 12 participants will be enrolled at approximately 2 centers in the United States.
Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo drug to be taken twice a day for 6 weeks |
|
| AVP-786 | Active Comparator | Participants randomized to AVP-786 will take one dose of AVP-786 once a day and one dose of placebo once a day for the first 7 days; from day 8, participants will receive AVP-786 twice a day for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-786 | Drug | d6-DM/Q |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI) | Baseline; Week 6, Week 8, and Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for the Total NPI Score | Baseline; Week 6, Week 8, and Week 14 | |
| Change From Baseline for the NPI Total Caregiver Distress | Baseline; Week 6, Week 8, and Week 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AVP-786; Placebo | In Period 1, participants were randomized to receive AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period. |
| FG001 | Placebo; AVP-786 | In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (6 Weeks) |
| |||||||||||||
| Period 2 (6 Weeks) |
|
A limited number of participants were enrolled prior to study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | AVP-786; Placebo | In Period 1, participants were randomized to receive AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) once a day (OD) in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 twice a day (BID) for 14 days. From Day 22, participants received a target dose of d6-DM 28 milligrams (mg)/Q 4.9 mg (AVP-786-28/4.9) BID for the remaining 3 weeks of Period 1. In Period 2, participants were randomized to receive matching placebo. The periods were separated by a 2-week washout period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI) | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
up to 22 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo for 6 weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
The study was terminated due to lack of enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Dubé, M.D. | Avanir Pharmaceuticals, Inc. | 949-389-6700 | sdube@avanir.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2015 | Sep 28, 2020 | Prot_SAP_000.pdf |
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| Placebo | Drug | matching placebo |
|
| Change From Baseline for the NPI Disinhibition Domain Caregiver Distress |
| Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 |
| Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 |
| Change From Baseline for the FBI Disinhibition Domain Score | Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14 |
| Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale | Week 3, Week 6, Week 11, and Week 14 |
| Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale | Week 3, Week 6, Week 11, and Week 14 |
| Change From Baseline for the Quality of Relationships (QoR) Scale | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Quality of Life (QoL) Scale | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Interpersonal Reactivity Index (IRI) | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS) | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Mini-Mental State Examination (MMSE) | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD) | Baseline; Week 6, Week 8, and Week 14 |
| Change From Baseline for the Stroop Color and Word Task | Baseline; Week 6, Week 8, and Week 14 |
| NOT COMPLETED |
|
| BG001 | Placebo; AVP-786 | In Period 1, participants were randomized to receive matching placebo. In Period 2, participants were randomized to receive AVP-786 OD in the morning and placebo in the evening for the first 7 days of the study. From Day 8, participants received AVP-786 BID for 14 days. From Day 22, participants received a target dose of AVP-786-28/4.9 BID for the remaining 3 weeks of Period 2. The periods were separated by a 2-week washout period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Change From Baseline for the Total NPI Score | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the NPI Total Caregiver Distress | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the NPI Disinhibition Domain Caregiver Distress | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 |
|
|
| Secondary | Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 |
|
|
| Secondary | Change From Baseline for the FBI Disinhibition Domain Score | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14 |
|
|
| Secondary | Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Week 3, Week 6, Week 11, and Week 14 |
|
|
| Secondary | Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Week 3, Week 6, Week 11, and Week 14 |
|
|
| Secondary | Change From Baseline for the Quality of Relationships (QoR) Scale | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Quality of Life (QoL) Scale | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Interpersonal Reactivity Index (IRI) | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS) | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Mini-Mental State Examination (MMSE) | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD) | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| Secondary | Change From Baseline for the Stroop Color and Word Task | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | Posted | Baseline; Week 6, Week 8, and Week 14 |
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | AVP-786 | Participants received AVP-786 (up to a target dose of d6-DM 28 milligrams [mg]/Q 4.9 mg [AVP-786-28/4.9] twice a day [BID]) for 6 weeks. | 0 | 1 | 0 | 1 | 1 | 1 |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
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