Health Condition 1: G890- Central pain syndrome
Conditions
Interventions
Intervention1: Levetiracetam: Levetiracetam 500mg OD x 1 month
if there is no headache reduction by 50% in headache frequency it will be increased to 500mg BD for 1 month and then 500mg TDS for the 3
Sponsors
JIPMER, Puducherry
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients with episodic migraine [having fewer than 15 monthly attacks of unilateral, pulsating, moderate/severe headache lasting 4-72 hours that is aggravated by physical activity associated with nausea, and/or photophobia and phonophobia and in some cases preceded by fully reversible CNS symptoms (aura)] where prophylaxis is indicated. 2. Aged 18-50 years 3. Not receiving any other prophylactic medi- cation for past one month. 4. Episodic migraine should be present for at least 12 months prior to evaluation for study inclusion
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients who have chronic migraine (at least 15 headache days/month with a minimum of 8 migraine days/month for at least 3 months 2. Non Migraine headaches (trigeminal autonomic cephalalgias, neuralgias, secondary headache) 3. Pregnant and lactating female patients, or plans to become pregnant during the study period 4. Subjects who are overusing alcohol or using illicit drugs as per DSM V 5. Patients with other co-morbidities like epilepsy,and other major illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess efficacy of levetiracetam in patients with episodic migraine in terms of decrease in migraine days per month from baselineTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ-9 and GAD-7Timepoint: 12 weeks;The secondary outcome parameters including: (i) One grade or more improvement in function- al disability score (MIDAS) (ii) Reduction in number of rescue medication (iii) 50% respond- er rate (iv) Moderate to severe headache daysTimepoint: 12 weeks;To assess the safety of levetiracetam in patients with episodic migraine in terms of adverse eventsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactPushkar Pazhani
JIPMER, Puducherry
Outcome results
None listed