Evaluation of safety and efficacy of add-on Alpha-lipoic acid on migraine prophylaxis in an adolescent population: A randomized controlled trial.

Nutraceuticals like Alpha-lipoic Acid may have potential benefits as a prophylactic agent for adolescent migraine with fewer adverse events than existing medications. The present study was conducted to evaluate the safety and efficacy of add-on Alpha-lipoic Acid for prophylaxis in adolescent migraine. A randomized, open-labeled, add-on clinical trial was conducted on 60 adolescent migraineurs who were randomized to receive flunarizine or flunarizine with an add-on Alpha-lipoic Acid. Clinical evaluation of the frequency and severity of migraine, responder rate, PedMIDAS scoring, serum thiol, and serum calcitonin gene-related peptide were done both at baseline and following 12 weeks of treatment. The frequency of acute attacks of migraine decreased significantly (P = 0.001) in the test group compared to the control group. The responder rate was found to be significantly (P = 0.001) higher (80%) in the test group than in the control group (33.3%). Mean monthly migraine headache days in the test group (-7.7; 95% CI: -9.1 to -6.3; P = 0.010) showed a significant reduction. The severity of acute migraine attacks also showed a significant reduction in the test group (P = 0.001). PedMIDAS scores showed significant improvement in the test group (P = 0.021) in comparison to the control group. Serum thiol levels were significantly increased (18; 95% CI: 13.5 to 36.1, P = 0.001) in the test group. Serum Calcitonin gene-related peptide showed significant reduction (-122.4; 95% CI: -142.3 to -89.0, P = 0.006) with adjunctive Alpha-lipoic Acid therapy. Add-on Alpha-lipoic Acid with flunarizine as a prophylactic agent for migraine in adolescents can improve clinical outcomes by improving clinical and biochemical parameters. ClinicalTrial.gov Identifier: NCT04064814 This article is protected by copyright. All rights reserved.