At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
Sumatriptan Succinatedrug
Likely dose
Sumatriptan Succinate via self-injectionAI-extracted
Key inclusion· 4
- ✓Diagnosis of migraine (with or without aura) or cluster headache per ICHD-II criteria
- ✓Migraine history persisting for at least 6 months
- ✓1 to 6 moderate or severe migraine attacks per month in the 2 months prior to enrollment
- ✓Cluster headache attacks lasting at least 45 minutes each
Key exclusion· 10
- ✕History of hypersensitivity to triptans or serious adverse event from triptan use
- ✕History of myocardial infarction, ischemic heart disease, or coronary vasospasm (atypical variant angina)
- ✕Cerebrovascular disorder or transient cerebral ischemic attack
- ✕Peripheral angiopathy including Raynaud's syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Imigran STATdose - Japan Clinical Experience Study for Self-injection
In Brief
A Phase 3 clinical trial evaluating Sumatriptan Succinate for Migraine Disorders. Completed, enrolled 75 participants across 4 sites.
Detailed Summary
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJul 2006
Primary CompletionAug 2006
TodayJul 2026
First PostedJul 26, 2006
Enrollment StartJun 20, 2006
Primary CompletionAug 7, 2006
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 19.9 years ago
Interventions
Sumatriptan Succinatedrug
Sumatriptan Succinate