Early Phase 1 Sleep Disorders Trial, Recruiting NCT06464367 Sponsor: Yale University Condition: Sleep Disorders
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Early Phase 1 Sleep Disorders Trial, Recruiting

NCT06464367
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 21 to 70 years old (inclusive)
  • People who have been diagnosed with migraine disease according to standard medical diagnostic guidelines (ICHD-3 criteria), or people who are generally healthy and do not have migraine (as a comparison group)

Who may not be able to join:

  • People with an unstable medical condition or a serious condition affecting the nervous system
  • People who are pregnant, breastfeeding, or do not have adequate birth control in place
  • People with a diagnosed psychotic or manic disorder
  • People who have used alcohol or other substances in a harmful or abusive way in the past 3 months
  • People who have used classic psychedelic substances (such as psilocybin, LSD, or mescaline) in the past 6 months
  • People who have used cannabis or THC-containing products in the past 2 weeks
  • People whose urine drug test comes back positive for drugs of abuse
  • People who have used triptan medications (such as sumatriptan) or ditan medications (such as lasmiditan) more than twice a week on average
  • People who have taken certain serotonin-affecting medications on a regular, ongoing basis (such as amitriptyline, fluoxetine, imipramine, or cyproheptadine) in the past 6 weeks
  • People who have used certain preventive or transitional migraine treatments that cause fluctuating symptom relief, such as botulinum toxin injections, certain antibody-based migraine prevention treatments, nerve block procedures, or chiropractic manipulation (confirm with trial site)
  • People with a history of a bleeding disorder or who are currently taking blood-thinning medications (such as warfarin, enoxaparin, dabigatran, or apixaban)
  • People who have taken anti-inflammatory pain medications such as ibuprofen or naproxen (NSAIDs) in the 7 days before or the 7 days after the PET scan procedure

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: 203-932-5711

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
19 May 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Baseline SV2A PET; Baseline RSFC; Change in SV2A PET after drug administration; Change in resting state functional connectivity (RSFC) after drug administration

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov