Asimadoline for Hot Flashes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called asimadoline for women experiencing moderate to severe hot flashes during menopause. The study aims to determine if asimadoline can safely and effectively reduce these symptoms. Participants will receive either the medication or a placebo for eight weeks, followed by a period where all receive the actual treatment for four weeks. Women who have gone through menopause or are in the late stages of perimenopause and experience frequent intense hot flashes might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
Yes, you will need to stop taking certain medications before joining the trial. Specifically, you cannot use hormone therapy, certain non-hormonal medications like SSRIs, SNRIs, gabapentin, pregabalin, clonidine, marijuana, or certain supplements and herbal therapies for 4 to 8 weeks before the screening visit.
Is there any evidence suggesting that asimadoline is likely to be safe for humans?
Research shows that asimadoline is under investigation for its safety and effectiveness in treating hot flashes and night sweats. Earlier studies have examined its tolerability and potential side effects. Some information suggests that researchers are assessing whether asimadoline has manageable side effects and its efficacy for individuals with these symptoms.
Since this trial is in an early phase, researchers continue to collect data on its safety and tolerability. This phase typically focuses on determining the optimal dose and monitoring for side effects. Although data collection is ongoing, testing in humans indicates it is considered safe enough for further study.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Asimadoline for treating hot flashes because it represents a novel approach compared to traditional options like hormone replacement therapy (HRT) and certain antidepressants. Unlike these treatments, Asimadoline is a kappa-opioid receptor agonist, which means it works on a different pathway in the body to potentially reduce hot flash frequency and intensity. This unique mechanism of action might offer relief without the hormonal side effects associated with HRT. Additionally, Asimadoline's oral administration could provide a convenient alternative for those who cannot or prefer not to use hormone-based therapies.
What evidence suggests that asimadoline might be an effective treatment for menopausal vasomotor symptoms?
Research has shown that kappa agonists, such as asimadoline, can help reduce hot flashes. One study found they might lower the number of these episodes by about 20%. This is particularly important for women experiencing moderate to severe menopausal symptoms, where hot flashes are a major issue. In this trial, participants will receive either asimadoline or a placebo. Asimadoline targets specific parts of the body to lessen these symptoms. Early results suggest it could be a promising option for effectively managing hot flashes.12467
Who Is on the Research Team?
Anne Dunlop - Principal Investigator, MD
Principal Investigator
Emory University
Sergey Sikora, VP of Clinical Affairs, PhD
Principal Investigator
Tioga Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for midlife women experiencing moderate to severe menopausal symptoms, specifically hot flashes. Participants should have a consistent history of these symptoms and be willing to record them daily before starting treatment. Women currently on hormone therapy or with certain health conditions may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 8 weeks of double-blind treatment with asimadoline TP0052 or placebo
Follow-up
Safety follow-up conducted via telephone post-treatment
Open-label extension
All patients undergo treatment with Asimadoline in an open label format
What Are the Treatments Tested in This Trial?
Interventions
- Asimadoline
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tioga Pharmaceuticals
Lead Sponsor