Pseudobulbar Affect (Involuntary Laughing and/or Crying)Phase 4NCT02496039
Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)
A Phase 4 study testing NUEDEXTA® in people with Pseudobulbar Affect (Involuntary Laughing and/or Crying), run by Avanir Pharmaceuticals at 2 sites in United States.
Trial summary
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pseudobulbar Affect (Involuntary Laughing and/or Crying)
- What is being tested?
- NUEDEXTA®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Centerville, Ohio, 45459
Study site
Miami, Florida, 33137
About this study
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
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
Read the detailed description
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.
- Being tested
- NUEDEXTA®
- Keywords
- PBA, involuntary crying, involuntary laughing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUEDEXTA®Drug
Also called dextromethorphan hydrobromide and quinidine
NUEDEXTA® only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: NUEDEXTA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: The study was terminated prematurely because of difficulty with recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pseudobulbar Affect (Involuntary Laughing and/or Crying)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496039
- Sponsor's protocol ID
- 15-AVR-404
- Status last verified
- Jun 2017
- First submitted
- 8 Jul 2015
- Last updated
- 3 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02496039
- Acronym / sponsor ID
- 15-AVR-404
- Keywords
- PBA, involuntary crying, involuntary laughing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because of difficulty with recruiting.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 3 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUEDEXTA® | Other | Drug: NUEDEXTA®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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUEDEXTA®Also: dextromethorphan hydrobromide and quinidineNUEDEXTA® only | Drug | NUEDEXTA® |
Primary outcome
Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)
Time frame: 180 days
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.
Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale
Time frame: 180 days
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.
Scores on the Clinical Global Impression of Change (CGIC) Scale
Time frame: 180 days
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.
Scores on the Patient Global Impression of Change (PGIC) Scale
Time frame: 180 days
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.
Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire
Time frame: 180 days
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.
Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale
Time frame: 180 days
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.
Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication
Time frame: 180 days
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.
Number of Participants Using Concomitant Psychotropic Medication
Time frame: 180 days
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.
Scores on the Impact of PBA on Informant Scale
Time frame: 180 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NUEDEXTA® in people with Pseudobulbar Affect (Involuntary Laughing and/or Crying), run by Avanir Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) (time frame: 180 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2017.