NCT04064814

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

Completed Phase 4 Last updated 25 July 2023

What this trial tests

Phase 4 trial testing Flunarizine 5mg in Adolescent Migraine in 60 participants. Completed in 30 June 2021.

Timeline

14 September 2019

Primary endpoint
30 April 2021

30 June 2021

Quick facts

Lead sponsor	All India Institute of Medical Sciences, Bhubaneswar
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	14 September 2019
Primary completion	30 April 2021
Estimated completion	30 June 2021
Sites	1 location across India

Drugs / interventions tested

• Flunarizine 5mg — full drug profile →
• Alpha lipoic acid 300mg — full drug profile →

Conditions studied

• Adolescent Migraine — all drugs for Adolescent Migraine →

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Who can join

Adults 10 to 19, any sex, with Adolescent Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging Pharmacological Treatments for Migraine in the Pediatric Population.
   Iannone LF, De Cesaris F, Geppetti P. · · 2022 · cited 10× · PMID 35455026 · DOI 10.3390/life12040536