This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Melatonin for Adolescent Migraine Prevention Study (MAP)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by Amy Gelfand, University of California, San Francisco
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Amy Gelfand, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03150797
First received: May 10, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose
This will be a randomized, multi-site double-blind placebo-controlled trial of melatonin (2 different dosing arms) vs. placebo for migraine prevention in adolescents. We intend to enroll approximately 210 participants over 15 months at two sites: UCLA and UCSF. The duration of participation for each participant will be 4 months.

Condition Intervention Phase
Migraine Drug: Melatonin Drug: Placebo oral capsule Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Prevention
Official Title: Melatonin for Adolescent Migraine Prevention Study (The MAP Study).

Resource links provided by NLM:


Further study details as provided by Amy Gelfand, University of California, San Francisco:

Primary Outcome Measures:
  • Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin treated participants vs. placebo. [ Time Frame: weeks 5-8 of randomized treatment phase ]

Secondary Outcome Measures:
  • Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. placebo. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 3 mg vs. placebo. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Mean migraine/migrainous days in weeks 5-8 of randomized treatment phase in melatonin 6 mg vs. melatonin 3 mg. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Change in mean migraine/migrainous days from weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase for each group. [ Time Frame: Weeks 5-8 of single-blind treatment phase to weeks 5-8 of randomized treatment phase. ]
  • Mean PedMIDAS (headache related disability score) in weeks 5-8 of randomized treatment phase in each melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Mean CASQ score in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Number of days acute medication is used in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]
  • Number of headache days in weeks 5-8 of randomized treatment phase in melatonin treated group vs. placebo, and in each of the three pair-wise group comparisons. [ Time Frame: Weeks 5-8 of randomized treatment phase. ]

Estimated Enrollment: 210
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin 3mg
Melatonin 3mg
Drug: Melatonin
Melatonin
Experimental: Melatonin 6mg
Melatonin 6mg
Drug: Melatonin
Melatonin
Placebo Comparator: Placebo oral capsule
Placebo
Drug: Placebo oral capsule
Placebo
Other Name: placebo

Detailed Description:

Participation includes 16 weeks of daily headache diary recording and taking the study pill every night, 1-2 hours before bed. Aside from the initial 1 hour enrollment visit, all remaining study procedures will be completed from home.

During the enrollment visit, history of migraine, questionnaires, a neurologic and physical exam (including weight, blood pressure, pulse, and respiratory rate) will be performed. Girls who have had their first period will undergo a urine pregnancy test and will be instructed to use birth control if they are sexually active.

For the first 8 week phase, participants will be instructed to take one study pill every night, 1-2 hours before bedtime and complete a daily headache diary from a smartphone. Phone call check-ins will occur at week 4 and week 8.

After the first 8 weeks of the study, participants who are eligible for the second phase of the study will be notified by study staff and will be sent the next set of study pills. Again, participants will be instructed to take the study pill every night, 1-2 hours before bedtime and complete a diary entry every evening.

Phone call check-ins will occur at week 12 and week 16. At the final 16 week phone call, additional questionnaires and study completion feedback will be collected.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 10-17—inclusive
  2. Weight ≥40 kg, so as not to require mg/kg based dosing
  3. Meets International Classification of Headache Disorders III beta1 criteria for migraine in children/adolescents (international standard diagnostic criteria for research)
  4. Lives in the state of California- to allow shipping of study medication from our pharmacy
  5. Has at least one parent who speaks English—in order to ensure good communication with study team by phone
  6. Has daily access to a smartphone in order to provide daily headache diary data
  7. A Parent/Guardian consents and the adolescent is cognitively capable of giving assent to participate
  8. Either not on a migraine preventive medication, or if on one the dose has been stable for at least 4 weeks prior to enrollment, or are willing to wait to start the study until they have reached a stable dose for 4 weeks
  9. Willing to not use OTC melatonin or change migraine preventives during the trial
  10. Has ≥1 headache day per week, or 4-28 days of headache in a 28-day period Episodic headaches have been present for a minimum of 6 months—This lowers the likelihood of a secondary cause of headaches

Exclusion Criteria:

  1. Continuous headache
  2. History of seizures/epilepsy
  3. Pregnant/lactating
  4. Concomitant opioid or barbiturate overuse, wherein overuse is defined as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds as these may impact sleepiness scales
  5. If in the investigator's opinion there is a medical or psychiatric concern that makes them think the participant should not participate
  6. Inability to swallow pills after teaching and practice History of nocturnal asthma, as evidenced by a having a diagnosis of asthma and symptoms that manifest as nighttime awakening due to cough, wheeze, and/or shortness of breath

Randomization Criteria:

  1. Had 4-28 migraine/migrainous days in the 28-day period of weeks 5-8 of single-blind placebo treatment phase, but not continuous headache.
  2. At least 80% compliance with headache diary (i.e. at least 23 headache diary days) during weeks 5-8 of single-blind placebo treatment phase.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03150797

Contacts
Contact: Amy A Gelfand, MD 415-885-7832 Amy.Gelfand@ucsf.edu
Contact: Laura A Dapkus, NCPT 415-885-7832 Laura.Dapkus@ucsf.edu

Locations
United States, California
UCLA Headache Research and Treatment Program Not yet recruiting
Los Angeles, California, United States, 90077
Contact: Andrew Charles, M.D.    415-885-7832    ACharles@mednet.ucla.edu   
Contact: Laura Dapkus, NCPT    415-885-7832    Laura.Dapkus@ucsf.edu   
University of California, San Francisco, (UCSF) Pediatric Brain Center
San Francisco, California, United States, 94158
Sponsors and Collaborators
Amy Gelfand
University of California, Los Angeles
Investigators
Principal Investigator: Amy A Gelfand, MD University of California San Francisco UCSF
  More Information

Publications:

Responsible Party: Amy Gelfand, Director of Pediatric Headache UCSF Benioff Children's Hospital, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03150797     History of Changes
Other Study ID Numbers: 16-19623
Study First Received: May 10, 2017
Last Updated: May 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy Gelfand, University of California, San Francisco:
UCSF
UCLA
melatonin
migraine
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 22, 2017