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The study was terminated prematurely because of difficulty with recruiting.
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6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
Eligible patients for this study must have a diagnosis of a neurological disorder affecting the brain of at least 3 months duration prior to baseline and which is not rapidly progressing and must have a diagnosis of Pseudobulbar affect (PBA).
This is a multicenter, open label study consisting of 6 months of treatment.
Approximately 125 patients will be enrolled at approximately 25 centers in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUEDEXTA® | Other | NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUEDEXTA® | Drug | NUEDEXTA® only |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Scores on the Clinical Global Impression of Change (CGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Scores on the Patient Global Impression of Change (PGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33137 | United States | |||
A total of 14 participants were screened for study enrollment; however, only 5 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate | Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate | Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180. |
| 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 | Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
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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 | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate | Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental status | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
The study was terminated prematurely because of difficulty with recruiting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadine Knowles; Executive Director, Research & Development Operations | Avanir Pharmaceuticals | 1-949-268-8972 | nknowles@avanir.com |
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| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
| D003915 | Dextromethorphan |
| D011802 | Quinidine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 180 days |
| Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Number of Participants Using Concomitant Psychotropic Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Scores on the Impact of PBA on Informant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days |
| Centerville |
| Ohio |
| 45459 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary | Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Scores on the Clinical Global Impression of Change (CGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Scores on the Patient Global Impression of Change (PGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Number of Participants Using Concomitant Psychotropic Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| Primary | Scores on the Impact of PBA on Informant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | Posted | 180 days |
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| 4 |
| 5 |
| Severe agitation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Worsening of urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Left leg tibia fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D011812 | Quinuclidines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |