Comparing amitriptyline and gabapentin in migraine preventio
Phase 4
- Conditions
- Health Condition 1: null- Migraine patients with headache frequency more than 4 per month
- Registration Number
- CTRI/2017/01/007743
- Lead Sponsor
- JIPMER Intramural fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
1. Migraine patients with headache frequency >4/month (diagnosed based on International Headache Society Criteria 3).
2. Migraine patients between 18 and 60 years of age, either gender.
Exclusion Criteria
A. Patients who have received any prophylactic medication for migraine during last 1 month.
B. Patients with history of drug allergy.
C. Uncontrolled hypertension, coronary artery disease.
D. Pregnancy, menstrual irregularity.
E. Liver or kidney dysfunction.
F. Systemic or psychiatric disease.
G. Malignancy.
H. Those unwilling to participate in study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess and compare the prophylactic effect of gabapentin and amitriptyline on frequency and intensity of headache among migraine patients. <br/ ><br>2. To compare the efficacy of amitriptyline and gabapentin on reducing the severity of headache using VAS score. <br/ ><br>Timepoint: 1.Patient will be initially assessed on Day 0 for headache frequency and severity and then will be assessed on Day 30,60,90 for assessing the change in headache frequency following starting amitriptyline and gabapentin. <br/ ><br>2.Pt will also be assessed on Day 30,60,90 for change in headache severity which will be assessed by change in Visual analogue scale (VAS) score <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To evaluate the effect of drug response on vascular biomarkers (Adiponectin & Leptin) in migraine prophylaxis. <br/ ><br>2. To compare improvement in functional disability score following treatment between amitriptyline and gabapentin. <br/ ><br>3. To compare the reduction in the number of rescue medications used between amitriptyline and gabapentin. <br/ ><br>4. To compare adverse drug reactions between amitriptyline and gabapentin <br/ ><br>Timepoint: 1. Serum adiponectin and leptin levels will be evaluated at baseline and at end of 3 months. <br/ ><br>2. Assessment of functional disability, reduction in use of number of rescue medication, adverse effects will be assessed on monthly basis till 3 months