Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03623321|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : June 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuropsychiatric Symptoms Related to Neurodegenerative Disease||Drug: Pimavanserin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease|
|Actual Study Start Date :||July 17, 2018|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
Experimental: Drug - pimavanserin
Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
• Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
- • Treatment-emergent adverse events (TEAEs) [ Time Frame: Treatment period and Follow-up period: 56 weeks ]
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): NCT03623321
|Contact: Jason Do||858-261-2971||Jdo@acadia-pharm.com|
|Contact: Brian Raetherfirstname.lastname@example.org|