Overview

This trial is active, not recruiting.

Conditions migraine, migraine headache, migraine disorders, migraine with aura, migraine without aura
Treatments ast-726 low dose, ast-726 high dose, ast-726 placebo
Phase phase 2
Sponsor Ariston Pharmaceuticals, Inc.
Start date May 2007
End date June 2008
Trial size 198 participants
Trial identifier NCT00285402, ARPH-Cl-03, Eudract no: 2005-003349-15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
ast-726 low dose
(Experimental)
ast-726 high dose
(Placebo Comparator)
ast-726 placebo

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 74 years old.

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

Additional Information

Official title Intranasal AST-726 Treatment for Prophylaxis of Migraine: A Placebo-Controlled Clinical Study
Principal investigator W. M. Mulleners
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Ariston Pharmaceuticals, Inc..