Migraine Trial, Recruiting NCT06077838 Sponsor: NYU Langone Health Condition: Migraine
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Migraine Trial, Recruiting

NCT06077838
Recruiting Not Applicable

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 who speak English (the app used in this trial is currently only available in English)
  • People aged 16 or older
  • People whose headaches meet a recognised medical definition of migraine, based on information assessed during the study screening process
  • People who have had headaches for at least 1 year, with a consistent pattern over the past 3 or more months
  • People who are willing to avoid making any changes to their migraine prevention medications for 3 months before the trial starts and throughout the 6-week treatment part of the study
  • People who experience between 4 and 29 headache days per month
  • People whose quality of life is affected enough by migraine to potentially benefit from the treatment, based on a specific questionnaire score (the MSQv2 score must be below 75 for the "role restrictive" section)

Who may not be able to join:

  • People who have had Cognitive Behavioural Therapy (CBT), Biofeedback, or other relaxation therapy for migraine in the past year
  • People with a history of alcohol or substance misuse, identified through self-reporting or medical records
  • People who have been diagnosed with medication overuse headache, or who use opioid or barbiturate medications
  • People whose depression symptom score on a questionnaire (PHQ-8) is greater than 15, which indicates moderately severe depressive symptoms
  • People who are unwilling or unable to follow a treatment program that uses written materials and audio recordings
  • People who do not own a smartphone
  • People who are pregnant

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Mia T Minen, MD, NYU Langone Health

Phone: 212-263-7744

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 November 2023
Est. completion
31 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score

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