Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510419
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2007-08-01
Brief Title:
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector The last visit will be done by a telephone follow-up call
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector The last visit will be done by a telephone follow-up call
Detailed Description:
Investigational Plan
1 Screening Visit Visit 0 0-14 days prior to receipt of study drug
2 Baseline Visit Visit 1 Provision of study drug and subject training
3 Treatment Visit Visit 2 within 72 hours after study drug administration
4 Follow-up Visit Visit 3 Telephone follow-up 7-10 days after study drug administration
1 Screening Visit Visit 0 0-14 days prior to receipt of study drug
2 Baseline Visit Visit 1 Provision of study drug and subject training
3 Treatment Visit Visit 2 within 72 hours after study drug administration
4 Follow-up Visit Visit 3 Telephone follow-up 7-10 days after study drug administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None