CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
MAP0004 +3 moredrug
Likely dose
MAP0004 1.0 mgfrom 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/NCT01089062
NCT01089062Phase 1Completed
CompareCT.gov

A Randomized, Double Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of Intravenous Dihydroergotamine (DHE) and Orally Inhaled DHE (MAP0004) on Pulmonary Arterial Pressure and Tolerability in Healthy Adults

Allergan·interventional·Posted Mar 18, 2010·Updated Jan 9, 2014

In Brief

A Phase 1 clinical trial evaluating MAP0004, IV Placebo (Saline), and 2 other interventions for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2010
Enrollment StartMar 1, 2010
Primary CompletionSep 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.3 years ago

Interventions

MAP0004drug

1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol

IV Placebo (Saline)drug

IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol

Placebo Inhalerdrug

Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.

IV Dihydroergotamine Mesylate (DHE)drug

IV DHE administered in Treatment A as per protocol