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Neurokinin Antagonist

ACER-801 50 mg BID for Hot Flashes

Phase 1 & 2
Waitlist Available
Led By Jennifer Boston, MSN, APNP
Research Sponsored by Acer Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 14
Awards & highlights

Study Summary

This trial is testing a new drug, ACER-801, to see if it can help treat hot flashes caused by menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accumulation ratio for AUC (ARcauc) of ACER-801
Accumulation ratio for AUC (ARcauc) of ACER-801 metabolite
Accumulation ratio for AUC (MRauc) of ACER-801 metabolite
+25 more
Secondary outcome measures
Change in frequency of vasomotor symptoms (hot flashes) from baseline
Change in severity of vasomotor symptoms (hot flashes) from baseline
Change in severity score vasomotor symptoms (hot flashes) from baseline

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ACER-801 50 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
Group II: ACER-801 200 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 200 mg BID (3 x 50 mg and 1 x placebo, twice daily)
Group III: ACER-801 100 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
Group IV: PlaceboPlacebo Group1 Intervention
Placebo (4 x Placebo of ACER-801 twice daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACER-801 50 mg BID
2022
Completed Phase 2
~50
ACER-801 100 mg BID
2022
Completed Phase 2
~50
ACER-801 200 mg BID
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Acer Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
174 Total Patients Enrolled
Jennifer Boston, MSN, APNPPrincipal InvestigatorSpaulding Clinical Research LLC
2 Previous Clinical Trials
206 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who might be a good candidate for this research project?

"This trial is looking for 56 female subjects aged 40-65 who have gone through menopause. Most notably, applicants are required to meet the following criteria:Post-menopausal female subjects 40-65 years of age, inclusive., At least 12 months of spontaneous, continuous amenorrhea, or At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL at screening, or At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy., With an average number of moderate to severe hot flashes/day for 2"

Answered by AI

Are patients being actively recruited for this clinical trial at this time?

"That is correct. The listing on clinicaltrials.gov clearly states that the study team is still recruiting patients for this trial. This particular trial was posted on 3/30/2022 and updated on 9/13/2022. They are currently looking to enroll 56 patients from 1 location."

Answered by AI

Does this experimental treatment have an age limit?

"This clinical trial requires that all participants are between 40 and 65 years old."

Answered by AI

What is the ceiling for the amount of people who can join this trial?

"The clinical trial is currently recruiting patients, as seen on clinicaltrials.gov. This specific study was posted on March 30th, 2020 and was last updated September 13th of the same year. The research team is looking for 56 individuals from a single location to participate."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
2022. "Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05325775.
~16 spots leftby Apr 2025
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