Pseudobulbar Affect (Involuntary Laughing and/or Crying) Clinical Trial
Official title:
A Study to Assess Effectiveness, Safety, and Health-related Outcomes of NUEDEXTA® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the Treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients
| Verified date | May 2016 |
| Source | Avanir Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration prior to baseline and which is not rapidly progressing - Diagnosis of Pseudobulbar Affect (PBA) - A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at Baseline - Minimum Data Set (MDS) information for patient available within 60 days prior to Baseline - Informant who is willing to comply with study procedures Exclusion Criteria: - Patients who have received NUEDEXTA® in the past 1 year - Patients with the diagnosis of Severe Depressive Disorder that would interfere with the conduct of the study - Patients who have a history of schizophrenia spectrum and other psychotic disorders - Patients with co-existent clinically significant or unstable systemic diseased that could confound the interpretation of the safety results of the study (e.g.,malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) - Patients with myasthenia gravis |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Avanir Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Center for Neurologic Study-Lability (CNS-LS) scale | to quantitavely measure the perceived frequency of PBA episodes | 180 days | No |
| Primary | Clinical Global Impression of Change (CGIC) scale | to assess treatment response by the clinician | 180 days | No |
| Primary | Patient Global Impression of Change (PGIC) scale | to assess treatment response by the patient or informant | 180 days | No |
| Primary | NPI-NH questionnaire | Neuropsychiatric Inventory - Nursing Home version | 180 days | No |
| Primary | Impact of PBA on Patient scale | This is a two-item scale that assesses the frequency and impact of Pseudbulbar Affect episodes on patient | 180 days | No |
| Primary | Impact of PBA on Informant scale | This is a three-items scale that assesses the time required to care for a patient and the burden on the informant | 180 days | No |