CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
ACER-801 50 mg BID +3 moredrug
Likely dose
ACER-801 50 mg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05325775
NCT05325775Phase 2Completed
CompareCT.gov

A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause

Acer Therapeutics Inc.·interventional·Posted Apr 13, 2022·Updated Aug 7, 2024

In Brief

A Phase 2 clinical trial evaluating ACER-801 50 mg BID, ACER-801 100 mg BID, and 2 other interventions for Post-menopausal Vasomotor Symptoms. Completed, enrolled 49 participants across 1 site.

Detailed Summary

In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes associated with menopause. Hot flashes are a change in your temperature that occurs due to changes in your hormones.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-menopausal Vasomotor Symptoms
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 13, 2022
Enrollment StartMar 30, 2022
Primary CompletionMar 4, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.2 years ago

Interventions

ACER-801 50 mg BIDdrug

50 mg BID (twice daily)

ACER-801 100 mg BIDdrug

100 mg BID (twice daily)

ACER-801 200 mg BIDdrug

200 mg BID (twice daily)

Placebodrug

Placebo