Trial Outcomes & Findings for Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA) (NCT NCT02496039)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

180 days

Results posted on

2017-07-03

Participant Flow

A total of 14 participants were screened for study enrollment; however, only 5 participants were enrolled.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	3
Overall Study Protocol Violation	1

Baseline Characteristics

Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate n=5 participants at risk 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.
Psychiatric disorders Altered mental status	20.0% 1/5
Psychiatric disorders Severe agitation	20.0% 1/5
Infections and infestations Worsening of urinary tract infection	20.0% 1/5
Injury, poisoning and procedural complications Left leg tibia fracture	20.0% 1/5

Other adverse events

Other adverse events
Measure	20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate n=5 participants at risk 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.
Infections and infestations Urinary tract infection	40.0% 2/5
Metabolism and nutrition disorders Hypoglycemia	20.0% 1/5
Injury, poisoning and procedural complications Fall	20.0% 1/5

Additional Information

Nadine Knowles; Executive Director, Research & Development Operations

Avanir Pharmaceuticals

Phone: 1-949-268-8972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER