Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: Tablet Rizatriptan: One 5 mg tablet orally single dose for an acute attack of migraine of moderate to severe intensity
Control Intervention1: Tablet Lasmiditan: One 100 mg tablet orally
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must have a history of migraine with or without aura, as defined by the International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria 2. History of migraine attacks for more than 6 months 3. Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours 4. Participant must be able to swallow a tablet 5. For participants taking migraine preventive medication, the treatment regimen is stable and has been taken for at least 3 months before screening 6. Participants must weigh at least 15 kilograms
Exclusion criteria
Exclusion criteria: 1. Patient diagnosed with another co-existent headache disorder 2. Chronic renal, gastrointestinal diseases, acid-peptic disease, hepatic, pulmonary or cardiac diseases 3. History of allergy to either of the study medications 4. Caregiver not providing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from pain of headache (pain intensity 0 on Numerical Rating Scale)Timepoint: At 2 hours after receiving the study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief, defined as at least a 2-point reduction in headache intensity from the baseline headache intensity on the Numerical Rating ScaleTimepoint: At 2 hours after receiving the study medication;Freedom from pain of headache (pain intensity 0 on Numerical Rating Scale)Timepoint: At 24 hours after receiving the study medication | — |
Countries
India
Contacts
Public ContactDr Prateek Kumar Panda
AIIMS, Rishikesh
Outcome results
None listed