Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)
Stopped early · Phase 4
Conditions studied: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
In brief
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
Key facts
- Study ID
- NCT02496039
- Run by
- Avanir Pharmaceuticals
- People needed
- 5
- Starts
- 2015-09-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2017-07-03
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Miami, Florida, United States
- Study site — Centerville, Ohio, United States
Full record on ClinicalTrials.gov
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