Study the effects of two drugs, amitriptyline and levetiracetam in migraine headache prevention

Efficacy and safety of amitriptyline and levetiracetam in episodic migraine prophylaxis: randomized double blinded placebo controlled double dummy trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023406

Enrollment

147

Registered

2020-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G430- Migraine without aura

Interventions

Intervention1: AMITRIPTYLINE, LEVETIRACETAM: Patient will be divided into 2 groups who will get intervention/ drug : one will receive amitriptyline (Oral tablets of 25 mg OD/BD or TDS for 3 months) an

Eligibility

Inclusion criteria

Inclusion criteria: 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 4.Patients should not have received any prophylactic medication for migraine during last 3 months

Exclusion criteria

Exclusion criteria: 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 )

Design outcomes

Primary

Measure	Time frame
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 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 Timepoint: 3 months	—

Secondary

Measure	Time frame
1.To compare the efficacy of amitriptyline and levetiracetam on reducing the severity of headache using VAS score.. 2.To compare improvement in functional disability score following treatment between amitriptyline and levetiracetam 3.To compare adverse drug reactions between amitriptyline and levetiracetam 4.To investigate Blink Reflex in episodic migraine patients 5.To see for depression and anxiety prevalence in patients with migraine Timepoint: 3 months	—

Measure

Time frame

1.To compare the efficacy of amitriptyline and levetiracetam on reducing the severity of headache using VAS score.. 2.To compare improvement in functional disability score following treatment between amitriptyline and levetiracetam 3.To compare adverse drug reactions between amitriptyline and levetiracetam 4.To investigate Blink Reflex in episodic migraine patients 5.To see for depression and anxiety prevalence in patients with migraine Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr VAIBHAV WADWEKAR

JIPMER

vaibhavwadwekar@yahoo.co.in7598566985

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026