Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population

NCT04064814 | Completed Phase 4

• 1 other identifier: AIIMSBBSR/PGThesis/2019-20/15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine causes a substantial impact on the physical and mental health of a child and it is a major cause for time-off school leading to impaired academic performance. Therefore prophylactic treatment is suggested for adolescents with frequent or disabling migraine, aiming at improving the function, quality of life and reducing disability. The most commonly used non-pharmacological agents for the prophylactic management of migraine in adolescents are nutraceuticals. Amongst all nutraceuticals, most commonly used agents for prophylaxis are coenzyme Q10, magnesium, riboflavin, feverfew and butterbur . Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism.ALA is a nutraceutical agent which also has neuroprotective and anti-inflammatory effects. It has been proved that the thiol level remains low in migraine patients. However, only one study has been done by Ali et al in the pediatric population where the combination of ALA and topiramate has shown promising results but the study result is not generalizable due to its inherent limitations. So, the study has been planned with an aim to evaluate the efficacy and safety of ALA as add-on therapy with flunarizine in the adolescent age group

Conditions

Adolescent Migraine

Keywords

Adolescent Migraine; Flunarizine; Alpha Lipoic Acid; Thiol Level; Calcitonin gene regulated peptide

Outcome Measures

Primary Outcomes (1)

• Mean monthly migraine attack rate

  Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid

  12 weeks

Secondary Outcomes (8)

• Responder rate

  12 weeks

• The number of days with migraine headache

  12 weeks

• The mean severity of acute attacks

  12 weeks

• The number of days with nausea or vomiting

  12 weeks

• The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score)

  12 weeks

Study Arms (2)

Flunarizine

ACTIVE COMPARATOR

flunarizine will be prescribed at a dose of 5mg once daily , orally for 12 weeks

Drug: Flunarizine 5mg

Alpha Lipoic Acid

EXPERIMENTAL

Alpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks

Drug: Flunarizine 5mg; Drug: Alpha lipoic acid 300mg

Interventions

Flunarizine 5mg DRUG

Flunarizine 5mg once daily,orally for 12 weeks

Alpha Lipoic Acid; Flunarizine

Alpha lipoic acid 300mg DRUG

Alpha lipoic acid 300mg ,once daily ,orally for 12 weeks

Alpha Lipoic Acid

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with "15 or more headache days per month with at least 8 days having migraine features for at least 3 months (according to the criteria of the International Classification of Headache Disorders, 3rd edition \[beta version\], or ICHD-3 beta)."
• Adolescent migraineurs aged 10 to 19 years of age of either sex.
• Patients and/or parents have given informed written consent/assent.

You may not qualify if:

• Patient with headache other than migraine.
• Patients who were on corticosteroids
• Treatment with any test drugs in the preceding three months from the start of the trial.
• If there is any history of interventions or devices used for the treatment of migraine, such as transcranial magnetic stimulation and nerve blocks during the 3 months before screening.
• Any other accompanying systemic illness; abnormalities revealed on neurologic examination.
• Psychiatric disturbances, history of epilepsy , learning disabilities, head trauma or use of other drugs acting on the central nervous system, including, smoking, alcohol consumption or any illicit drug abuse

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (11)

• Karsan N, Prabhakar P, Goadsby PJ. Premonitory Symptoms of Migraine in Childhood and Adolescence. Curr Pain Headache Rep. 2017 Jul;21(7):34. doi: 10.1007/s11916-017-0631-y.

  PMID: 28647791 BACKGROUND

• Eiland LS, Jenkins LS, Durham SH. Pediatric migraine: pharmacologic agents for prophylaxis. Ann Pharmacother. 2007 Jul;41(7):1181-90. doi: 10.1345/aph.1K049. Epub 2007 Jun 5.

  PMID: 17550953 BACKGROUND

• O'Brien HL, Kabbouche MA, Hershey AD. Treating pediatric migraine: an expert opinion. Expert Opin Pharmacother. 2012 May;13(7):959-66. doi: 10.1517/14656566.2012.677434. Epub 2012 Apr 14.

  PMID: 22500646 BACKGROUND

• D'Onofrio F, Raimo S, Spitaleri D, Casucci G, Bussone G. Usefulness of nutraceuticals in migraine prophylaxis. Neurol Sci. 2017 May;38(Suppl 1):117-120. doi: 10.1007/s10072-017-2901-1.

  PMID: 28527067 BACKGROUND

• Wang J, Tang J, Zhou X, Xia Q. Physicochemical characterization, identification and improved photo-stability of alpha-lipoic acid-loaded nanostructured lipid carrier. Drug Dev Ind Pharm. 2014 Feb;40(2):201-10. doi: 10.3109/03639045.2012.753901. Epub 2013 Jan 22.

  PMID: 23336811 BACKGROUND

• Magis D, Ambrosini A, Sandor P, Jacquy J, Laloux P, Schoenen J. A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis. Headache. 2007 Jan;47(1):52-7. doi: 10.1111/j.1526-4610.2006.00626.x.

  PMID: 17355494 BACKGROUND

• Sorge F, De Simone R, Marano E, Nolano M, Orefice G, Carrieri P. Flunarizine in prophylaxis of childhood migraine. A double-blind, placebo-controlled, crossover study. Cephalalgia. 1988 Mar;8(1):1-6. doi: 10.1046/j.1468-2982.1988.0801001.x.

  PMID: 3282670 BACKGROUND

• Abu-Arafeh I, Hershey AD, Diener HC, Tassorelli C; Clinical Trials Standing Committee and the Child and Adolescent Standing Committee of the International Headache Society. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition. Cephalalgia. 2019 Jun;39(7):803-816. doi: 10.1177/0333102419842188. Epub 2019 Apr 4.

  PMID: 30947525 BACKGROUND

• Sorge F, Marano E. Flunarizine v. placebo in childhood migraine. A double-blind study. Cephalalgia. 1985 May;5 Suppl 2:145-8. doi: 10.1177/03331024850050S227.

  PMID: 2861907 BACKGROUND

• Kenney D, Jenkins S, Youssef P, Kotagal S. Patient Use of Complementary and Alternative Medicines in an Outpatient Pediatric Neurology Clinic. Pediatr Neurol. 2016 May;58:48-52.e7. doi: 10.1016/j.pediatrneurol.2015.11.003. Epub 2016 Jan 11.

  PMID: 26923752 BACKGROUND

• Puliappadamb HM, Satpathy AK, Mishra BR, Maiti R, Jena M. Evaluation of Safety and Efficacy of Add-on Alpha-Lipoic Acid on Migraine Prophylaxis in an Adolescent Population: A Randomized Controlled Trial. J Clin Pharmacol. 2023 Dec;63(12):1398-1407. doi: 10.1002/jcph.2331. Epub 2023 Aug 24.

  PMID: 37563914 DERIVED

MeSH Terms

Interventions

Flunarizine; Thioctic Acid

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Rituparna Maiti, MD

  Additional Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized, open Label , active controlled study

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: September 14, 2019
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)