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Levetiracetam for prophylactic treatment of pediatric migraine: A randomized double-blind placebo-controlled trial
Hadi Montazerlotfelahi1, Man Amanat2, Ali Reza Tavasoli3
1Pediatrics Center of Excellence, Department of Pediatric Neurology, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.
Insights
Levetiracetam effectively reduced migraine frequency and intensity in children. This anti-seizure drug offers a promising option for pediatric migraine prevention, with manageable side effects.
Area of Science:
- Neurology
- Pediatrics
- Clinical Trials
Background:
- Limited pharmacologic options exist for pediatric migraine prophylaxis.
- Levetiracetam, an anti-seizure medication, shows potential for migraine reduction in adults.
- This study investigates levetiracetam for preventing migraines in children.
Purpose of the Study:
- To evaluate the safety and efficacy of levetiracetam in pediatric migraine prevention.
- To assess changes in migraine frequency and intensity.
- To monitor adverse events associated with levetiracetam use.
Main Methods:
- A randomized, double-blind, placebo-controlled trial.
- Inclusion criteria: children aged 4-17 with frequent or severe migraines.
- Primary outcomes: change in monthly headache frequency and intensity; secondary outcome: adverse effects.
Main Results:
- Sixty-one participants completed the study (31 levetiracetam, 30 placebo).
- Levetiracetam significantly reduced migraine frequency and intensity compared to placebo.
- 68% of levetiracetam recipients experienced >50% episode reduction vs. 30% in placebo (p=0.007).
- Reported adverse effects included irritability, daytime sedation, and mild tics.
Conclusions:
- Levetiracetam demonstrates potential utility in preventing pediatric migraines.
- The drug may decrease the frequency and severity of migraine episodes in children.
- Levetiracetam appears to be a viable option for migraine prophylaxis in pediatric patients.
Introduction:
Few drugs are available for migraine prophylaxis in children. Levetiracetam is a broad-spectrum anti-seizure drug that has been suggested to be effective in reducing adult migraine episodes. We assessed the safety and efficacy of levetiracetam in the prevention of pediatric migraine.
Methods:
A randomized double-blind placebo-controlled trial was performed. Eligible participants were aged 4-17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes. Primary endpoints were the mean changes in monthly frequency and intensity of headaches from the baseline phase to the last month of the double-blind phase. Safety endpoint was the adverse effects reported.
Results:
Sixty-one participants (31 taking levetiracetam and 30 taking placebo) completed the study. All had a significant reduction in frequency and intensity of episodes that was significantly greater in the levetiracetam arm. Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group (p-value: 0.007). Irritability, day-time sedation, and mild tic were reported.
Conclusion:
Levetiracetam may be useful in migraine prevention and may decrease migraine episodes and severity.
Trial Registration:
The study is prospectively registered with Iranian Registry of Clinical Trials; IRCT.ir, number IRCT2017021632603N1.
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