Study the effects of two drugs, amitriptyline and levetiracetam in migraine headache preventio
- Conditions
- Health Condition 1: G430- Migraine without aura
- Registration Number
- CTRI/2020/02/023406
- Lead Sponsor
- SAURABH NANDWANI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Other Inclusion criteria
1.Migraine without aura criteria according to the International Classification of Headache Disorders third edition for at least 1 year
2. Age of onset of migraine before 50 years,
3. At least three migraine headache per month and headache( migraine or non migraine) attacks <15 days per month during each of the 3 months prior to the screening visit and the reference period
4.Patients should not have received any prophylactic medication for migraine during last 3 months
1.Patients with history of drug allergy.
2.Severe psychiatric disease
3.Uncontrolled hypertension, coronary artery disease.
4.Pregnant and lactating women.
5.Liver or kidney dysfunction.
6.History of Malignancy.
7.Those who abuse alcohol or other drugs ( according to DSM IV criteria )
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To compare the effect of prophylaxis with amitriptyline and levetiracetam compared to placebo on frequency of migraine days among patients with episodic migraine over 3 months period <br/ ><br> <br/ ><br>â?¢To compare the effect of prophyaxis with levetiracetam vs amitriptyline on frequency of migraine days among patients with episodic migraine over 3 months period <br/ ><br>Timepoint: 3 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To compare the efficacy of amitriptyline and levetiracetam on reducing the severity of headache using VAS score.. <br/ ><br>2.To compare improvement in functional disability score following treatment between amitriptyline and levetiracetam <br/ ><br>3.To compare adverse drug reactions between amitriptyline and levetiracetam <br/ ><br>4.To investigate Blink Reflex in episodic migraine patients <br/ ><br>5.To see for depression and anxiety prevalence in patients with migraine <br/ ><br>Timepoint: 3 months