Health Condition 1: null- Migraine in adult patients
Conditions
Interventions
Intervention1: Eletriptan Hydrobromide equivalent to eletriptan 40mg oral conventional tablets: One tablet will be taken orally at the start of a migraine episode. Patients who do not adequately respo
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and female adult patients aged 18 to 65 years and having the diagnosis of migraine with or without aura according to International Headache Society criteria 2)May or may not be taking prophylactic treatments for migraine 3)Frequency of migraine episodes is 1 to 6 per month 4)Minimum duration of the illness is 1 year 5)Migraine onset is before the age of 50 years 6)Female patients who meet the above criteria must also meet the following additional criteria: - Post-menopausal - If of child-bearing potential, must be using medically acceptable contraception, and must consent to use barrier method of contraception before entry and throughout the study, or are surgically sterilised, or has a male partner who has undergone sterilization - Must have a negative result of serum pregnancy test at screening 7)Subjects fulfilling the above criteria and who are willing to provide their informed consent, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 8)Subjects must be willing to fill-up the migraine diary (provided to them) during each migraine attack and up to three times that they may suffer over the study period 9)Subjects must be compliant with self-administration of medication.
Exclusion criteria
Exclusion criteria: A patient is excluded from the study if he or she meets any of the following criteria: 1)Atypical migraine that has consistently failed to respond to migraine therapy 2)Concomitant frequent non-migrainous headache (e. g., more than 6 attacks per month on average) 3)Presence of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction 4)Any acute or unstable medical condition 5)Conditions associated with severely limited gastrointestinal absorption 6)Any medical condition (including documented hypersensitivity) that contraindicates the use of triptan drugs 7)Use of drugs that can interact with the triptans 8)History of misuse of analgesic drugs (defined as use of >50 g of aspirin or >100 tablets of analgesics in one week) or ergotamine (defined as use on >2 days per week) 9)Misuse or abuse of alcohol or other substances, based on the Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV) criteria 10)Clinically significant abnormal laboratory test values at baseline 11)Subjects whose baseline electrocardiogram (ECG) has been reported other than "within normal limits" 12)Use of investigational drugs within 1 month prior to screening 13)Unable or unwilling to provide written informed consent 14)Not willing to fill-up the migraine diary during an episode of migraine 15) Pregnant women and lactating mothers 16)Women of child-bearing potential not taking effective contraceptive precaution 17)Women of child-bearing potential not consenting to use barrier contraceptives 18)Have a history of repeated non-compliance with treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-h headache responseTimepoint: After 1st migraine episode | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Functional response (2)2-h pain-free response (3)Relief of migraine-associated symptoms (4)Overall patient acceptability of the study medication (5)Consistency of headache response at 2 hours Timepoint: After 1st , 2nd and 3rd migraine episodes | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
AGM Medical Services
Outcome results
None listed