Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
NCT ID: NCT01089062
Last Updated: 2014-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Treatment A, then Treatment B, then Treatment C
The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Treatment A, then Treatment C, then Treatment B
The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Treatment B, then Treatment A, then Treatment C
The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Treatment B, then Treatment C, then Treatment A
The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Treatment C, then Treatment A, then Treatment B
The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Treatment C, then Treatment B, then Treatment A
The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.
MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Interventions
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MAP0004
1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
IV Placebo (Saline)
IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
Placebo Inhaler
Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
IV Dihydroergotamine Mesylate (DHE)
IV DHE administered in Treatment A as per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception
4. Stable cardiac status
5. Normal hemoglobin values
6. Normal Echocardiogram
7. Normal or not clinically significant 12-lead Electrocardiogram
8. Demonstrated ability to properly use the Tempo® Inhaler
9. Subject has not donated blood in the last 56 days
Exclusion Criteria
2. Use of any excluded concomitant medications within the 10 days prior to Visit 1
3. History of hemiplegic or basilar migraine
4. Participation in another investigational trial during the 30 days prior to Visit 1
18 Years
45 Years
ALL
Yes
Sponsors
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MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
INDUSTRY
Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J Noveck, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Unit
Locations
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Duke Clinical Research Unit
Durham, North Carolina, United States
Countries
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References
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Noveck RJ, Douglas PS, Chow SC, Mangum B, Kori S, Kellerman DJ. Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine. Drug Des Devel Ther. 2013 Jul 24;7:619-25. doi: 10.2147/DDDT.S44093. Print 2013.
Other Identifiers
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MAP0004-CL-P102
Identifier Type: -
Identifier Source: org_study_id
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