Phase 2
N=84
CHOCOlate MeLatonin for AdolescenT MigrainE
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03597529 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Mean Visual Analog Scale (VAS) Score — -2.3; -2.7 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Melatonin (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Amy Gelfand
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Visual Analog Scale (VAS) Score |
-2.3; -2.7 | — |
Summary
Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.
Eligibility Criteria
Inclusion Criteria
- Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
- Age 3-17 years
- Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
- If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.
Exclusion Criteria
- Allergy or intolerance to melatonin, or to chocolate.
- Opioid or barbiturate overuse as defined in ICHD
- Pregnant/lactating
Data sourced from ClinicalTrials.gov (NCT03597529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.