COMPLETED

Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if drug MTX101 works to treat acute migraine attacks in adults. It will also learn about the safety of the drug MTX101. The main questions it aims to answer are: Does the drug MTX101 lower headache pain for participants and the need to use a rescue medication? What side effects, if any, do participants have when taking the drug MTX101? Researchers will compare the drug MTX101 to a placebo (a look-alike substance that contains no drug) to see if the drug MTX101 works to treat acute migraine attacks. Participants will: Take the drug MTX101 or a placebo to treat 1 migraine attack with each treatment. Visit the clinic twice and have one phone call over a 4 week period for checkups and tests. Keep a diary of their symptoms and the number of times they use a rescue medication.

Official Title

A Pilot, Phase 2a, Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Study to Evaluate Safety and Efficacy of Sublingual MTX101 for the Acute Treatment of Migraine Headaches in Adults

Quick Facts

Study Start:2025-02-24
Study Completion:2025-07-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06728553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female aged 18 to 65 years at the time of consent.
  2. 2. Onset of migraine headache before age 50.
  3. 3. History of episodic migraine headache starting at least 1-year ago with or without aura.
  4. 4. Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
  5. 5. Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
  6. 6. Able to understand and provide signed informed consent.
  7. 7. Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
  1. 1. No more than a total of 15 headache days per month.
  2. 2. Use of more than 2 migraine preventive medications.
  3. 3. Current diagnosis of glaucoma.
  4. 4. Use of opioids or barbiturates more than 4 days/month, triptans or ergots 10 or more days/month, or simple analgesics (e.g., aspirin, NSAIDs, acetaminophen) 15 or more days/month in the 3 months prior to Visit 1.
  5. 5. Current diagnosis of any post-traumatic headaches, medication overuse headaches, new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), painful cranial neuropathy or daily headaches.
  6. 6. Vaccination within less than 7 days from the Screening or plans to get a vaccine during the study or within a week after final study dose.

Contacts and Locations

Principal Investigator

Chief Medical Officer
STUDY_DIRECTOR
Sponsor GmbH

Study Locations (Sites)

Kaizen Brain Center
La Jolla, California, 92037
United States
Clinical Research Institute, LLC
Santa Monica, California, 90048
United States
Brainstorm Research
Miami, Florida, 33176
United States
Synergy Clinical Research/Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32504
United States
DelRicht Research
New Orleans, Louisiana, 70115
United States
QUEST Research Institute
Farmington Hills, Michigan, 48334
United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Manistee Therapeutics

  • Chief Medical Officer, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2025-07-28

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2025-07-28

Terms related to this study

Keywords Provided by Researchers

  • acute treatment of migraine
  • nervous system diseases
  • central nervous system diseases
  • brain diseases
  • headache
  • migraine with or without aura

Additional Relevant MeSH Terms

  • Migraine