Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
Status:
Recruiting
Trial end date:
2021-10-30
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar