Adolescent Migraine Clinical Trial
Official title:
Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population: A Randomized Controlled Trial
Verified date | July 2023 |
Source | All India Institute of Medical Sciences, Bhubaneswar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | AIIMS | Bhubaneswar | Odisha |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, Bhubaneswar |
India,
Abu-Arafeh I, Hershey AD, Diener HC, Tassorelli C; Clinical Trials Standing Committee and the Child and Adolescent Standing Committee of the International Headache Society. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition. Cephalalgia. 2019 Jun;39(7):803-816. doi: 10.1177/0333102419842188. Epub 2019 Apr 4. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean monthly migraine attack rate | Change in the mean monthly migraine attack rate from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks | |
Secondary | Responder rate | percentage of patients having =50% reduction in migraine frequency from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks | |
Secondary | The number of days with migraine headache | The number of days with migraine headache from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks | |
Secondary | The mean severity of acute attacks | 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 | |
Secondary | The number of days with nausea or vomiting | The number of days with nausea or vomiting from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks | |
Secondary | The headache disability will be assessed by pedMIDAS (pediatric migraine disability assessment score) | 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 | |
Secondary | The relapse rate among the responders after stoppage of prophylactic therapy . | The relapse rate among the responders after stoppage of prophylactic therapy over the next 12 weeks. | 12 weeks | |
Secondary | Serum thiol levels | Serum thiol levels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks | |
Secondary | Serum CGRP | Serum CGRPlevels from baseline after treatment with Flunarizine vs Alpha Lipoic Acid | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01016678 -
Treximet Early Intervention Adolescent Migraine
|
Phase 2/Phase 3 |