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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nuedexta (DM 20 mg/Q 10 mg)

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

Group Type OTHER

Nuedexta (DM 20 mg/Q 10 mg)

Intervention Type DRUG

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

Interventions

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Nuedexta (DM 20 mg/Q 10 mg)

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

Intervention Type DRUG

Other Intervention Names

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Nuedexta

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Unstable neurologic disease
* Severe dementia
* Stroke within 3 months
* Penetrating TBI
* Contraindications to Nuedexta
* Severe Depressive Disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No