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Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)

NCT01799941 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2017-03-15

Study results available
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Summary

The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Conditions

  • Pseudobulbar Affect (PBA)
  • Stroke
  • Dementia
  • Traumatic Brain Injury (TBI)

Interventions

DRUG

Nuedexta (DM 20 mg/Q 10 mg)

Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Sponsors & Collaborators

  • Avanir Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799941 on ClinicalTrials.gov