Last updated: 11/04/2018 12:30:18
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Imigran STATdose - Japan clinical experience study for self-injection
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of participants with headache Relief at 60 minutes post dose(Migraine) or 30 minutes Post dose(Cluster Headache)
Timeframe: 30 minutes or 60 Minutes after each administration
Secondary outcomes:
Number of participants with subject-rated acceptability of the sumatriptan 3mg kit product
Timeframe: Up to 2 months
Percentage of participants with investigator/sub investigator-rated successful self-injection rate
Timeframe: Up to 2 months
Interventions:
Drug: Sumatriptan Succinate
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
2006-07-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
June 2006 to August 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
- History of migraine or cluster headache persisting for at least 6 months
- History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
- History of serious adverse event attributable to treatment with Imigran® Injection 3
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
- History of migraine or cluster headache persisting for at least 6 months
- Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
- Cluster Headache: Each attack persisting for at least 45 minutes
- Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.
Exclusion criteria:
- History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
- History of serious adverse event attributable to treatment with Imigran® Injection 3
- History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
- Previous history of cerebrovascular disorder or transient cerebral ischemic attack
- Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
- Systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >95 mmHg at the start of treatment period
- Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine
- Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans
- Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures.
- Epilepsy or organic cerebral disorder which may lead to convulsion
- Previous history of hypersensitivity to sulfonamides
- Known drug allergy or idiosyncrasies
- Known drug dependency or alcoholism
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-07-08
Actual study completion date
2006-07-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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