An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
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ClinicalTrials.gov Identifier: NCT05645432 |
Recruitment Status :
Completed
First Posted : December 9, 2022
Last Update Posted : December 22, 2023
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Sponsor:
Sage Therapeutics
Information provided by (Responsible Party):
Sage Therapeutics
Tracking Information | |||||
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First Submitted Date ICMJE | December 1, 2022 | ||||
First Posted Date ICMJE | December 9, 2022 | ||||
Last Update Posted Date | December 22, 2023 | ||||
Actual Study Start Date ICMJE | May 10, 2023 | ||||
Actual Primary Completion Date | November 21, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to approximately 7 days ] An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of investigational product (IP), or any worsening of a pre-existing medical condition/adverse event with onset after the start of IP and throughout the study.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus | ||||
Official Title ICMJE | An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus | ||||
Brief Summary | The primary objective of this study is to evaluate the safety and tolerability of brexanolone in participants with tinnitus following a single 6-hour continuous intravenous (IV) infusion. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Tinnitus | ||||
Intervention ICMJE | Drug: Brexanolone
Brexanolone IV infusion
Other Names:
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Study Arms ICMJE | Experimental: Brexanolone
Participants will receive a continuous, 6-hour IV infusion of Brexanolone on Day 1 of the Treatment Period.
Intervention: Drug: Brexanolone
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | November 21, 2023 | ||||
Actual Primary Completion Date | November 21, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05645432 | ||||
Other Study ID Numbers ICMJE | 547-TRM-201 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sage Therapeutics | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Sage Therapeutics | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sage Therapeutics | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |