Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
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|ClinicalTrials.gov Identifier: NCT00285402|
Recruitment Status : Unknown
Verified February 2008 by Ariston Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : February 2, 2006
Last Update Posted : February 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Migraine Migraine Headache Migraine Disorders Migraine With Aura Migraine Without Aura||Drug: AST-726 Low dose Drug: AST-726 High dose Drug: AST-726 Placebo||Phase 2|
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 involves a number of other symptoms, including pain with a pulsating or throbbing quality, nausea or vomiting, sensitivity to light and sound, visual disturbances or aura. Currently the management of migraine may be either acute treatment or prophylaxis. Acute migraine treatment aims at aborting or reversing already present migraine symptoms with acute administration of medicine such as with triptans, whereas migraine prophylaxis aims to reduce the frequency and severity of migraine attacks over time through chronic medication.
The overall protocol design and outcome measurements of this study follow the guidelines and durations recommended by the International Headache Society for prophylaxis studies of migraine medications.
The study ARPH-CL-03 is a multicenter, randomized, double-blind, three parallel group design with moderate to severe migraine patients to assess the ability of daily administration of AST-726 at one of two doses to reduce the number of headache days in a 4 week period more than in patients that receive a placebo. AST-726 and the placebo will be self-administered by intranasal spray daily for 12 weeks. Among other efficacy and safety assessments, patients will have be asked to collect information on a daily migraine diary.
Patients will be instructed on the allowed use of acute migraine medications during this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||June 2008|
|Estimated Study Completion Date :||June 2008|
Drug: AST-726 Low dose
Drug: AST-726 High dose
|Placebo Comparator: C||
Drug: AST-726 Placebo
- The primary outcome variable will be change in number of migraine headache days during standardized 30-day observation periods during treatment period and baseline period. The number of headache days reported in the patient diary will be standardized. [ Time Frame: 30 days ]
- 1 Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period [ Time Frame: 4 weeks ]
- 2 The number of migraine headache attacks in each treatment period [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285402
|Principal Investigator:||W. M. Mulleners||Canisius-Wilhelmina Zeikenhuis|