Preventive management of headache due to migraine.

Phase 4

• Conditions: Health Condition 1: null- (l) Patients diagnosed with migraine by ICHDIII criteria. (2) Presence of an indication for prophylactic treatment.(3) Adult and adolescent(more than 12 yrs).(4) Drug naive patients of migraine

• Registration Number: CTRI/2017/07/009074
• Lead Sponsor: Ratul Banerjee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

l. Patients diagnosed with migraine, according to the 3rd edition of International Classification of Headache Disorders III criteria of International Headache Society .

2. Presence of an indication for prophylactic treatment that is intolerable headache attacks that were either debilitating or resulted in significant loss of daily function, frequent attacks that is more than 4 attacks per month.

3. Adult and adolescent of age more than 12 years.

4. Drug naive patients that is no history of proper anti-migraine treatment.

Exclusion Criteria

l. Patients with headache causes other than migraine such as cluster headache, headache caused by space occupying lesions, etc will be excluded.

2. Patients having migraine with other comorbidities.

3. Patients having baseline ECG changes, having dyslipidemia. Creatinine level more

thanl.5mg/dl, and SGOT &SGPT level more than thrice the normal, FPG more than l26mgldl and PPG more than 2OOmg/dl.

4. Patients with concomitant major medical or psychiatric disorder on first evaluation e.g. major

depression, psychosis, dementia, etc.

5. Pregnant and lactating mother.

6. Any known allergy or contraindications to the study drug or drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy among Sodium Valporate, Topiramate and Flunarizine plus Propranolol combination in prophylaxis of migraine as measured by MIDAS Score.Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
1.To assess the safety profile of the study drugs --cardiac, renal and hepatic along with treatment emergent adverse effects with each of the medications. <br/ ><br>2.To assess the impact on general health related quality of life by the aforesaid treatment by <br/ ><br>the EQ-5 D-5L QuestionnaireTimepoint: At 12 and 24 weeks interval.