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Randomized Trial for Comparison between amitriptyline alone and amitriptyline with topiramate combination in chronic migraine ,whether single drug is better or combination of these 2 drugs

A comparison of efficacy and safety of topiramate and amitriptyline Vs amitriptyline alone in chronic migraine : A randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033356
Enrollment
100
Registered
2021-05-04
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: G437- Chronic migraine without aura Health Condition 2: G438- Other migraine

Interventions

Intervention1: group 1 -amitriptyline and topiramate combination: topiramate will be prescribed 25 mg daily in ist week then increased to 25 mg weekly upto 100 mg daily .amitriptyline will be started

Sponsors

Principal Investigator Prof Jayantee Kalita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients with chronic migraine attending neurology service will be included diagnosis of chronic migraine will be based on ICHD-3 beta criteria (2013)- adults >18 to h/o at least 8 attacks of migraine (with or without aura )per month in last 3 months h/o >15 headache days per month for >3 months history of migraine (with or without aura)for >12 months prior to enrollment

Exclusion criteria

Exclusion criteria: patients with uncontrolled diabeties/hypertension ,heart diseases,psychiatric disease,seizures,hearing deficit,ear disease,visual deficit,stroke like illness,infection,organ failure,malignancy,asthamatics,immunosuppressant,systemic disease,age 55 years ,migraine onset after 50 years of age ,on prophylactic treatment in past one month ,abortive medication with opioid drugs,pregnancy,and unwilling for consent

Design outcomes

Primary

MeasureTime frame
primary outcome-more than 50% reduction in headache days secondary outcome- severity in vas score number of abortive medication mMIDAS SCORE Migraine physical function impact diary severe adverse eventsTimepoint: base line ,ist and 3rd month

Secondary

MeasureTime frame
severity in vas score number of abortive medication mMIDAS SCORE Migraine physical function impact diary severe adverse eventsTimepoint: baseline ,ist and 3rd month

Countries

India

Contacts

Public ContactABHISHEK

SGPGIMS

jayanteek@yahoo.com09450411673

Outcome results

None listed

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