Migraine Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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