Health Condition 1: G437- Chronic migraine without aura Health Condition 2: G438- Other migraine
Conditions
Interventions
Intervention1: Propranolol 160mg: Propranolol will be given while raising the dose from 40 mg to 160 mg in weekly increments and then administerd for 20 weeks and finally tapered over next 4 weeks to
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18-65 years, either male or female who fulfills the diagnostic criteria laid down by ICHD 3 for Chronic migraine and not on any prophylactic treatment.
Exclusion criteria
Exclusion criteria: All patients with a clinical phenotype of CM but on further investigation, found to have a secondary cause for their headaches will be excluded. Pregnant women, patient with known allergies against propranolol and/or topiramate, patients with history of bronchial asthma, Chronic obstructive pulmonary disease (COPD), diabetes, bradycardia or heart blocks, congestive heart failure (CHF), glaucoma, renal stones, dementia, psychosis and severe depression shall be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints 1. Change in migraine days per 28 days (Migraine day is defined as a calendar day when the patient reported â?¥4 continuous hours of headache meeting ICHD 3 criteria for migraine)Timepoint: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Frequency parameters 1. Change in headache days per 28 days (Headache day is defined as a calendar day [00:00 to 23:59] when the patient reported â?¥4 continuous hours of headache episode in the diary) 2. More than 50% reduction in headache days compared to baseline. 3. Migraine free days per month. 4. Number of days and dosage of drug taken to abort the acute attacks (analgesics/triptans/ergotamines)Timepoint: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.;B. Severity parameters 1. Change in average Visual analogue scale (VAS) score at the end of each month.Timepoint: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.;C. Adverse eventsTimepoint: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial.;D. Impact on headache disorder and associated disability 1. Headache Impact Test (HIT) 2. Migraine Disability Assessment (MIDAS) 3. Change in migraine specific quality of life (MSQOL) 4. Global impression of changeTimepoint: It will be assessed at the baseline and then after 20 weeks of drug administration i.e at week 24 of trial. | — |
Countries
India
Contacts
Public ContactLUV BANSAL
GIPMER
Outcome results
None listed