Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01832350|
Recruitment Status : Unknown
Verified July 2017 by St. Joseph's Hospital and Medical Center, Phoenix.
Recruitment status was: Active, not recruiting
First Posted : April 16, 2013
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Pseudobulbar Affect (PBA)||Drug: Nuedexta (20/10)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Protocol of a Prospective, Open-label Study to Assess the Safety and Efficacy of Nuedexta (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Alzheimer's Disease|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Nuedexta (20/10)
Drug: Nuedexta (20/10) administered orally, two times a day (every 12 hours), during a 26-week period.
Drug: Nuedexta (20/10)
Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.
Other Name: Dextromethorphan/Quinidine
- reduction of PBA frequency [ Time Frame: 1, 13, and 26 weeks after initiation of treatment ]
- reduction of PBA severity [ Time Frame: 1, 13, and 26 weeks after initiation of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832350
|United States, Arizona|
|Barrow Neurological Institute|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Jiong Shi, MD, PhD||Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix AZ|