The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.
This is a multi-center study to evaluate the effect of NOE-115, a monoamine modulator, in patients with moderate to severe vasomotor symptoms (hot flashes) due to menopause. Women will participate in the study for a total of approximately 12 weeks, comprising a screening period (4 weeks), treatment period (4 weeks), and a follow up period (4 weeks). The study is single arm but enrollment will occur in two cohorts. In Cohort, enrolled women will receive NOE-115 at a daily Dose A for the entire 4-week treatment period. Cohort 1 participants will return to the clinic on specified days per protocol for tolerability assessments. Cohort 2 will enroll participants after the acceptable safety/tolerability of NOE-115 Dose A has been determined from Cohort 1. Administration of NOE-115 will start on Study Day 1 and will continue daily for 4 weeks and will start at Dose A of NOE-115 as defined by the study protocol. Participants will receive NOE-115 up to a maximum- daily dose based on Investigator decision. Cohort 2 participants will return to the clinic on specified days per protocol for tolerability assessments and possible dose increases of NOE-115.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity.
Noema PMM-201 Site #104
San Diego, California, United States
Noema PMM-201 Site #102
Jacksonville, Florida, United States
Noema PMM-201 Site #101
Atlanta, Georgia, United States
Noema PMM-201 Site #106
Las Vegas, Nevada, United States
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason
Occurrence of withdrawal from the study by the participant due to adverse event. An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study
Time frame: 4 weeks
Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)
An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study
Time frame: 4 weeks
Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4
Severity of the hot flashes will be assessed by participants using a daily hot flash diary from baseline to Week 4 of the study
Time frame: 4 weeks
Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4
Hot flash frequency will be assessed by participants using a daily hot flash diary from baseline to Week 4
Time frame: 4 weeks
Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4
The CGI-S rating is based upon observed and reported symptoms, behavior, and function in the past seven days and asks the clinician one question: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" which is rated on the following seven-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients
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Noema PMM-201 Site #103
Seattle, Washington, United States
Time frame: 4 weeks