Migraine Clinical Trial
Official title:
A Placebo-Controlled, Group Sequential, Adaptive Treatment Assignment Study of Intravenous COL-144 (LY573144) in the Acute Treatment of Migraine
This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.
This study is set up:
- to evaluate the efficacy (headache response at two hours) of a range of intravenous
doses of COL-144 in order to select a dose range for further evaluation,
- to explore the time course and effect of a range of dose levels of COL-144 on features
of the migraine including: headache response, proportion of participants pain-free,
headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue
medication, patient global impression and vomiting
- to explore the safety and tolerability of a range of doses of COL-144 in terms of
adverse events, physical exam, vital signs, laboratory evaluations, and ECGs
- to determine key PK parameters for COL-144 and to explore the relationship between the
PK of COL-144 and the time course and extent of clinical response
;
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