Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01089062

Run by

Allergan

People needed

24

Starts

2010-03-01

Expected to finish

2010-12-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide a signed, executed written informed consent
• Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
• Female subjects who are practicing adequate contraception
• Stable cardiac status
• Normal hemoglobin values
• Normal Echocardiogram
• Normal or not clinically significant 12-lead Electrocardiogram
• Demonstrated ability to properly use the Tempo® Inhaler
• Subject has not donated blood in the last 56 days

You may not qualify if…

• Contraindication to dihydroergotamine mesylate (DHE)
• Use of any excluded concomitant medications within the 10 days prior to Visit 1
• History of hemiplegic or basilar migraine
• Participation in another investigational trial during the 30 days prior to Visit 1

Where it is running

• Duke Clinical Research Unit — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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