Status:
COMPLETED
Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Adolescent Migraine
Eligibility:
All Genders
10-19 years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04064814
Start Date
September 14 2019
End Date
June 30 2021
Last Update
July 25 2023
Active Locations (1)
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1
AIIMS
Bhubaneswar, Odisha, India, 751019