A Phase 4 interventional study of NUEDEXTA® in Pseudobulbar Affect (Involuntary Laughing and/or Crying), sponsored by Avanir Pharmaceuticals. Terminated at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-07-03.
Sponsored by Avanir Pharmaceuticals (part of Otsuka Holdings Co., Ltd.) · Phase 4, Interventional, and Other
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.
39 studies on the registry are indexed under Crying; 8 are open to participants now.
This study's enrollment of 5 is below the median of 90 across 34 interventional studies indexed under Crying.
Browse Crying studies →Avanir Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted after Avanir Pharmaceuticals became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: NUEDEXTA®
NUEDEXTA® only
Also known as: dextromethorphan hydrobromide and quinidine
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 days
| Milestone | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| Started | 5 |
| Completed | 1 |
| Not completed | 4 |
| Withdrew: Adverse event | 3 |
| Withdrew: Protocol violation | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate | 0/5 (0%) | 3/5 (60%) | 4/5 (80%) |
| Event | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| Altered mental statusPsychiatric disorders | 1/5 |
| Severe agitationPsychiatric disorders | 1/5 |
| Worsening of urinary tract infectionInfections and infestations | 1/5 |
| Left leg tibia fractureInjury, poisoning and procedural complications | 1/5 |
| Event | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| Urinary tract infectionInfections and infestations | 2/5 |
| HypoglycemiaMetabolism and nutrition disorders | 1/5 |
| FallInjury, poisoning and procedural complications | 1/5 |
| Age, Categorical(Participants) | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| Female | 4 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dextromethorphan