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

July 24, 2023 updated by: Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar

Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flunarizine
flunarizine will be prescribed at a dose of 5mg once daily , orally for 12 weeks
Drug: Flunarizine 5mg
Flunarizine 5mg once daily,orally for 12 weeks
Experimental: Alpha Lipoic Acid
Alpha Lipoic Acid will be prescribed at a dose of 300mg once daily,orally for 12 weeks
Drug: Flunarizine 5mg
Flunarizine 5mg once daily,orally for 12 weeks
Drug: Alpha lipoic acid 300mg
Alpha lipoic acid 300mg ,once daily ,orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean monthly migraine attack rate
Time Frame: 12 weeks
Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: 12 weeks
percentage of patients having ≥50% reduction in migraine frequency from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks
The number of days with migraine headache
Time Frame: 12 weeks
The number of days with migraine headache from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks
The mean severity of acute attacks
Time Frame: 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
12 weeks
The number of days with nausea or vomiting
Time Frame: 12 weeks
The number of days with nausea or vomiting from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks
The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score)
Time Frame: 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
12 weeks
The relapse rate among the responders after stoppage of prophylactic therapy .
Time Frame: 12 weeks
The relapse rate among the responders after stoppage of prophylactic therapy over the next 12 weeks.
12 weeks
Serum thiol levels
Time Frame: 12 weeks
Serum thiol levels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks
Serum CGRP
Time Frame: 12 weeks
Serum CGRPlevels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: Rituparna Maiti, MD, Additional Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMSBBSR/PGThesis/2019-20/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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