Abstract Details

Title Double-Blind, Placebo Controlled, Randomized Clinical Trial Comparing Melatonin 3 mg, Amitriptyline 25 mg and Placebo for Migraine Prevention

Topic Headache

Presentation(s) S40 - (-)

Poster/Presentation
Number 005

Background Melatonin has been linked to migraine mechanisms in several ways. Previous reports have shown therapeutic effects on migraine and other headache disorders. Amitriptyline has been widely used for migraine prevention, but its unfavorable side effect profile limits its use. Better tolerable options in migraine prophylaxis are necessary.

Objective

Design/Methods A randomized, double-blind, placebo-controlled multicentric study was carried out. Men and women, aged 18-65 years, with migraine with or without aura, experiencing 2-8 attacks per month, were recruited from the general population. After a 4-week baseline phase, 196 subjects were randomized to receive either placebo, amitriptylne 25 mg or melatonin 3 mg for 3 months. The primary outcome was migraine frequency in number of headache days per month. Secondary endpoints were migraine intensity, duration, and analgesic use. Tolerability were also measured in the three groups.

Results One hundred seventy nine subjects completed the study. Mean reduction in headache frequency was 2.7 in the melatonin group, 2.18 for amitriptyline, and 1.18 for placebo. Melatonin significantly reduced headache frequency compared to placebo (p=0,009), but not to amitriptyline (p=0,19). Melatonin was as tolerable as placebo and better tolerable when compared to amitriptyline.

Conclusions This study showed that melatonin 3 mg is better than placebo for migraine prevention, and better tolerable than amitriptyline 25 mg.

Authors/Disclosures
Mario F. Peres, MD (Sao Paulo Headache Center) PRESENTER	Dr. Peres has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eurofarma. Dr. Peres has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Peres has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Libbs. Dr. Peres has received research support from CNPq. Dr. Peres has received research support from Allergan.
Tomas Uher	Tomas Uher has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Tomas Uher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol myers. Tomas Uher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Tomas Uher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. The institution of Tomas Uher has received research support from Novartis.
	No disclosure on file

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