CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
MAP0004 +1 moredrug
Likely dose
MAP0004 1.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01199965
NCT01199965Phase 2Completed
CompareCT.gov

An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers

Allergan·interventional·Posted Sep 13, 2010·Updated Jan 9, 2014

In Brief

A Phase 2 clinical trial evaluating MAP0004 and IV DHE for Healthy Subjects. Completed, enrolled 47 participants across 1 site.

Detailed Summary

Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers. Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited Kingdom
CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.8 years ago

Interventions

MAP0004drug

1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol

IV DHEdrug

IV DHE administered at Visit 2 or 3 as per protocol