Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
Condition: Adolescent Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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
    

Detailed 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. Pharmacological
      agents commonly used for migraine prophylaxis in adolescents are topiramate, cyproheptadine,
      amitriptyline, valproate, propranolol and flunarizine. These preventive medications are
      effective first-line treatment but the associated adverse effects have limited their use
      amongst the adolescent population. In this clinical scenario nutraceuticals may be an
      alternative option.

      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 . Despite being
      largely used for prophylaxis of adolescent migraine, sufficient evidences are lacking which
      support the safety and efficacy of these agents. The findings from the previous studies on
      riboflavin and coenzyme Q10 are conflicting and inconclusive. Thus there is a need for a
      clinically effective nutraceutical in migraine prophylaxis.

      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. In some recent studies, ALA has been found to be beneficial in migraine prophylaxis
      in adults. 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.

      From the literature search, it is evident that there is a lack of data on the efficacy and
      safety of ALA as a prophylactic agent in migraine. 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. The choice of flunarizine as standard prophylactic therapy in the
      present study is supported by the fact that flunarizine is efficacious and safer in the
      adolescent population due to its fewer adverse effects in comparison to topiramate and
      propranolol.
    

Intervention name(s): Flunarizine 5mg; Alpha lipoic acid 300mg
Intervention type(s): Drug; Drug
Intervention description(s): Flunarizine 5mg once daily,orally for 12 weeks; Alpha lipoic acid 300mg ,once daily ,orally for 12 weeks
Intervention MeSH terms: Thioctic Acid; Flunarizine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open Label , active controlled study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent Migraine; Flunarizine; Alpha Lipoic Acid; Thiol Level; Calcitonin gene regulated peptide