Completed PHASE4 INTERVENTIONAL 1-arm NCT01799941

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

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

Sponsor: Avanir Pharmaceuticals

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

Interventions Nuedexta (DM 20 mg/Q 10 mg)

Updated 7 times since 2017 Last updated: Jan 26, 2017 Started: Feb 28, 2013 Primary completion: May 31, 2015 Completion: May 31, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Dementia and Pseudobulbar Affect (PBA), this trial is completed. The trial is conducted by Avanir Pharmaceuticals and has accumulated 7 data snapshots since 2013. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
May 2017 — Jun 2018 [monthly]

Completed PHASE4

Status: Unknown Status → Completed

▶ Show 2 earlier versions

Feb 2017 — May 2017 [monthly]

Unknown Status PHASE4

Status: Active Not Recruiting → Unknown Status
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE4

First recorded

Feb 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Avanir Pharmaceuticals

Data source: Avanir Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Pensacola, United States