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

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ClinicalTrials.gov Identifier: NCT04064814
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Monalisa Jena, M.D., 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


Condition or disease Intervention/treatment Phase
Adolescent Migraine Drug: Flunarizine 5mg Drug: Alpha lipoic acid 300mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open Label , active controlled study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population: A Randomized Controlled Trial
Actual Study Start Date : September 14, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Serum thiol levels [ Time Frame: 12 weeks ]
    Serum thiol levels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid

  8. Serum CGRP [ Time Frame: 12 weeks ]
    Serum CGRPlevels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064814


Contacts
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Contact: Monalisa Jena, MD 9438884193 pharm_monalisa@aiimsbhubaneswar.edu.in
Contact: Biswa Ranjan Mishra, MD 9438884220 brm1678@gmail.com

Locations
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India
AIIMS Recruiting
Bhubaneswar, Odisha, India, 751019
Contact: Monalisa Jena, MD    9438884193    pharm_monalisa@aiimsbhubaneswar.edu.in   
Sub-Investigator: Biswa Ranjan Mishra, MD         
Sub-Investigator: Amit Kumar Satpathy, MD         
Sub-Investigator: Haridas M P, MBBS         
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Study Director: Rituparna Maiti, MD Additional Professor
Publications:

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Responsible Party: Dr. Monalisa Jena, M.D., Assistant professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT04064814    
Other Study ID Numbers: AIIMSBBSR/PGThesis/2019-20/15
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar:
Adolescent Migraine
Flunarizine
Alpha Lipoic Acid
Thiol Level
Calcitonin gene regulated peptide
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thioctic Acid
Flunarizine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Vasodilator Agents