Completed

PRISM IIA Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)

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What is being tested

Nuedexta (DM 20 mg/Q 10 mg)

Drug
Who is being recruted

Mental Disorders+12

+ Brain Diseases

+ Brain Injuries

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorAvanir Pharmaceuticals
Last updated: March 15, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks. Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study. The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.

NCT01799941
Principal SponsorAvanir Pharmaceuticals
Last updated: March 15, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

367 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesBrain InjuriesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersCraniocerebral TraumaNervous System DiseasesVascular DiseasesWounds and InjuriesNeurocognitive DisordersTrauma, Nervous SystemBrain Injuries, TraumaticDementiaStroke

Criteria

3 inclusion criteria required to participate
Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater
Clinical diagnosis of Pseudobulbar Affect (PBA)
Documentation of Neurologic disease or brain injury
6 exclusion criteria prevent from participating
Contraindications to Nuedexta
Penetrating TBI
Severe Depressive Disorder
Severe dementia
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pensacola, United StatesOpen in Google Maps
CompletedOne Study Center