Status:
UNKNOWN
Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
Lead Sponsor:
Ariston Pharmaceuticals, Inc.
Conditions:
Migraine
Migraine Headache
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The purpose of this migraine prevention study is to evaluate the efficacy and safety of AST-726 in moderate to severe migraine patients at one of two doses compared to placebo and compared to a baseli...
Detailed Description
Migraine patients may experience repeated migraine attacks, lasting from four hours to three days or more. Each attack is characterized by severe pain, typically on one side of the head and often invo...
Eligibility Criteria
Inclusion
- Primary
- Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
- Has had migraines for at least 6 months prior to study enrollment period.
- Migraines began before age 50.
- Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 months prior to study enrollment.
- Has 2 to 10 attacks in 30 days during the Baseline Period.
- Additional inclusion criteria in protocol
- Primary
Exclusion
- Has headache equal to or greater than 18 days per month.
- Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
- Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine \[DHE\]) greater than 15 days per month.
- Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
- Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.
- Additional exclusion criteria in protocol
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00285402
Start Date
May 1 2007
End Date
June 1 2008
Last Update
February 8 2008
Active Locations (19)
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1
Mediwest Research Centre Oy
Koskenalantie 16, Seinajoki, Finland, 60220
2
Turun Headache Center, Ltd. (Turun Paansarkykeskus Oy)
Brahenkatu 11D, Turku, Turku, Finland, 20100
3
Suomen Terveystalo Jyvaskyla
Jyväskylä, Vainonkatu 30, Finland, 40100
4
Headache Center, Tammertutka
Hameenkatu 18 6th Floor, Tampere, Finland, 33200