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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
Sponsor:
Information provided by:
Ariston Pharmaceuticals, Inc.

Study Description
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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 baseline period as measured by a reduction in the number of migraine days.

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

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: AST-726 Low dose
Experimental: B Drug: AST-726 High dose
Placebo Comparator: C Drug: AST-726 Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. 2 The number of migraine headache attacks in each treatment period [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  1. Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
  2. Has had migraines for at least 6 months prior to study enrollment period.
  3. Migraines began before age 50.
  4. 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.
  5. Has 2 to 10 attacks in 30 days during the Baseline Period.

Additional inclusion criteria in protocol

Primary Exclusion Criteria:

  1. Has headache equal to or greater than 18 days per month.
  2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
  3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine [DHE]) greater than 15 days per month.
  4. Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
  5. Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.

Additional exclusion criteria in protocol

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Ariston Pharmaceuticals, Inc.
Investigators
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Principal Investigator: W. M. Mulleners Canisius-Wilhelmina Zeikenhuis
More Information
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Responsible Party: John A. McLane, Ariston Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00285402    
Other Study ID Numbers: ARPH-Cl-03
Eudract no: 2005-003349-15
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: February 2008
Keywords provided by Ariston Pharmaceuticals, Inc.:
Migraine
Migraine prophylaxis
Migraine prevention
Chronic migraine treatment
Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations