A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03287869|
Recruitment Status : Completed
First Posted : September 19, 2017
Results First Posted : August 17, 2020
Last Update Posted : August 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder Acute Mania||Drug: Brexpiprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder|
|Actual Study Start Date :||October 24, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Brexpiprazole was administered in participants orally with flexible dosing from 2 mg/day from Days 1 to 3 regardless of treatment assignment in the previous double-blind trial, followed by titration to 3 mg/day on Day 4. Participants may have been titrated (or re-titrated) to a higher dose of brexpiprazole, up to a maximum of 4 mg/day, based on treatment response and at the investigator's discretion anytime at Day 7 or thereafter. Participants who were unable to tolerate their current dose could have been titrated down to a minimum of 2 mg/day any time after Day 4.
Other Name: OPC-34712
- Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity [ Time Frame: From Day 1 (after dosing) through 29 weeks (26 weeks treatment, 3 weeks safety follow-up) ]An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs severity were graded on a 3-point scale as: 1 = mild; discomfort noticed, but no disruption to daily activity, 2 = moderate; discomfort sufficient to reduce or affect normal daily activity, and 3 = severe; inability to work or perform normal daily activity.
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): NCT03287869