Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Ariston Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ariston Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00285402
First received: January 31, 2006
Last updated: February 6, 2008
Last verified: February 2008

January 31, 2006
February 6, 2008
May 2007
June 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00285402 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 2 The number of migraine headache attacks in each treatment period [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 1. Number of subjects that respond with at least a 50% decrease in migraine days in each given 4-week Treatment Period
  • 2. The number of migraine headache attacks in each treatment period
Not Provided
Not Provided
 
Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine
Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • 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
  • Experimental: A
    Intervention: Drug: AST-726 Low dose
  • Experimental: B
    Intervention: Drug: AST-726 High dose
  • Placebo Comparator: C
    Intervention: Drug: AST-726 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
198
June 2008
June 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Netherlands,   Finland
 
NCT00285402
ARPH-Cl-03, Eudract no: 2005-003349-15
No
John A. McLane, Ariston Pharmaceuticals, Inc
Ariston Pharmaceuticals, Inc.
Not Provided
Principal Investigator: W. M. Mulleners Canisius-Wilhelmina Zeikenhuis
Ariston Pharmaceuticals, Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP