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Randomized Controlled Trial
. 2023 Dec;63(12):1398-1407.
doi: 10.1002/jcph.2331. Epub 2023 Aug 24.

Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial

Haridas Mundot Puliappadamb  1 , Amit Kumar Satpathy  2 , Biswa Ranjan Mishra  3 , Rituparna Maiti  1 , Monalisa Jena  1
Affiliations
Randomized Controlled Trial

Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial

Haridas Mundot Puliappadamb et al. J Clin Pharmacol. 2023 Dec.

Abstract

Nutraceuticals like alpha-lipoic acid (ALA) may have potential benefits as prophylactic agents for adolescent migraine, with fewer adverse events than existing medications. The present study was conducted to evaluate the safety and efficacy of add-on ALA for prophylaxis in adolescent migraine. A randomized, open-label, add-on clinical trial was conducted with 60 adolescent migraineurs, who were randomized to receive flunarizine or flunarizine with an add-on ALA. A clinical evaluation of the frequency and severity of migraine, responder rate, Pediatric Migraine Disability Assessment (PedMIDAS) scoring, serum thiol, and serum calcitonin gene-related peptide (CGRP) was performed both at baseline and following 12 weeks of treatment. The frequency of acute attacks of migraine decreased significantly (P = .001) in the test group compared with the control group. The responder rate was found to be significantly higher (80%) in the test group than in the control group (33.3%) (P = .001). The mean monthly migraine headache days in the test group showed a significant reduction (-7.7 days, 95%CI -9.1 to -6.3 days; P = .010). The severity of acute migraine attacks (mild, moderate, severe) also showed a significant reduction in the test group (P = .001). PedMIDAS scores showed significant improvement in the test group (P = .021), in comparison with the control group. Serum thiol levels were significantly increased in the test group (18 mmol/L, 95%CI 13.5 to 36.1 mmol/L; P = .001). Serum CGRP levels showed a significant reduction with adjunctive ALA therapy (-122.4 pg/mL, 95%CI -142.3 to -89.0 pg/mL; P = .006). Add-on ALA with flunarizine as a prophylactic agent for migraine in adolescents can improve clinical outcomes by improving clinical and biochemical parameters.

Trial registration: ClinicalTrials.gov NCT04064814.

Keywords: CGRP; PedMIDAS; adolescent migraine; alpha-lipoic acid; flunarizine; thiol.

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References

    1. Karsan N, Prabhakar P, Goadsby PJ. Premonitory symptoms of migraine in childhood and adolescence. Curr Pain Headache Rep. 2017;21(7):34.
    1. Eiland LS, Jenkins LS, Durham SH. Pediatric migraine: pharmacologic agents for prophylaxis. Ann Pharmacother. 2007;41(7):1181-1190.
    1. Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche M. Effectiveness of topiramate in the prevention of childhood headaches. Headache. 2002;42(8):810-818.
    1. O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother. 2012;13(7):959-966.
    1. Reiter PD, Nickisch J, Merritt G. Efficacy and tolerability of intravenous valproic acid in acute adolescent migraine. Headache. 2005;45(7):899-903.

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