Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
- Conditions
- Adolescent Migraine
- Interventions
- Drug: Alpha lipoic acid 300mg
- Registration Number
- NCT04064814
- Lead Sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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 who have not taken any prophylactic treatment within the last three months before their inclusion in the study.
- Patients and/or parents have given informed written consent/assent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alpha Lipoic Acid Flunarizine 5mg Alpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks Alpha Lipoic Acid Alpha lipoic acid 300mg Alpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks Flunarizine Flunarizine 5mg flunarizine will be prescribed at a dose of 5mg once daily , orally for 12 weeks
- Primary Outcome Measures
Name Time Method Mean monthly migraine attack rate 12 weeks Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
- Secondary Outcome Measures
Name Time Method Serum thiol levels 12 weeks Serum thiol levels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
The number of days with migraine headache 12 weeks The number of days with migraine headache from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
The mean severity of acute attacks 12 weeks The mean severity of acute attacks will be considered as severity basis where 3 will be severe and 1 will be mild attack (on a 3-point scale: 3, severe; 2, moderate; 1, mild) from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
The relapse rate among the responders after stoppage of prophylactic therapy . 12 weeks The relapse rate among the responders after stoppage of prophylactic therapy over the next 12 weeks.
Serum CGRP 12 weeks Serum CGRPlevels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
The number of days with nausea or vomiting 12 weeks The number of days with nausea or vomiting from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Responder rate 12 weeks percentage of patients having ≥50% reduction in migraine frequency from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score) 12 weeks The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score) scoring system (denotes 0 to 10 as little to no dyability and greater than 50 as severe disability) from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
Trial Locations
- Locations (1)
AIIMS
🇮🇳Bhubaneswar, Odisha, India