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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, then Treatment B, then Treatment C | Other | 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. |
|
| Treatment A, then Treatment C, then Treatment B | Other | 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. |
|
| Treatment B, then Treatment A, then Treatment C | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP0004 | Drug | 1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose | AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery. | 2 hours from time of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose | Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery. | baseline and 2 hours from the time of first dose |
| Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Noveck, M.D., Ph.D. | Duke Clinical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23926420 | Derived | 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. |
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This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then B, Then 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 Intravenous (IV) Dihydroergotamine (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. |
| FG001 | Treatment A, Then C, Then 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. |
| FG002 | Treatment B, Then A, Then 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. |
| FG003 | Treatment B, Then C, Then 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. |
| FG004 | Treatment C, Then A, Then 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. |
| FG005 | Treatment C, Then B, Then 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 2 (Randomization) |
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| Visit 3 |
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| Visit 4 |
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| Follow-up Visit (Final Visit) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A, Then B, Then C | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose | AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery. | Patients with available data at the required time point were included in the analysis population. | Posted | Mean | Standard Deviation | mmHg*min | 2 hours from time of first dose |
|
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All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Scientific Affairs | MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan | 650-386-3100 | dkellerman@mappharma.com |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D004087 | Dihydroergotamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Treatment B, then Treatment C, then Treatment A | Other | 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. |
|
| Treatment C, then Treatment A, then Treatment B | Other | 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. |
|
| Treatment C, then Treatment B, then Treatment A | Other | 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. |
|
| IV Placebo (Saline) | Drug | IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol |
|
| Placebo Inhaler | Drug | 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 |
|
|
Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery. |
| baseline and 2 hours from the time of first dose |
| AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose | AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery. | 4 hours from the time of first dose |
| Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods | Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure. | baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose |
| Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose | The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment A, Then C, Then B |
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG002 | Treatment B, Then A, Then C | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG003 | Treatment B, Then C, Then A | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG004 | Treatment C, Then A, Then B | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG005 | Treatment C, Then B, Then A | Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose. Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Treatment C | Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. |
|
|
| Secondary | Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose | Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery. | Patients with available data at the required time point were included in the analysis population. | Posted | Number | percentage of participants | baseline and 2 hours from the time of first dose |
|
|
|
| Secondary | Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose | Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery. | Patients with available data at the required time point were included in the analysis population. | Posted | Mean | Standard Deviation | mmHg | baseline and 2 hours from the time of first dose |
|
|
|
| Secondary | AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose | AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery. | Patients with available data at the required time point were included in the analysis population. | Posted | Mean | Standard Deviation | mmHg*min | 4 hours from the time of first dose |
|
|
|
| Secondary | Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods | Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure. | Patients with available data at the required time point were included in the analysis population. | Posted | Mean | Standard Deviation | mmHg | baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose |
|
|
|
| Secondary | Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose | The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | Patients with available data at the required time point were included in the analysis population. | Posted | Mean | Standard Deviation | milliseconds | baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose |
|
|
|
| 0 |
| 20 |
| 19 |
| 20 |
| EG001 | Treatment B | Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose. | 0 | 20 | 10 | 20 |
| EG002 | Treatment C | Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose. | 0 | 20 | 6 | 20 |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sensory Disturbance | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sensation of pressure | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pharmaceutical product complaint | Social circumstances | MedDRA (11.1) | Systematic Assessment | Medication Aftertaste |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D017670 |
| Sodium Compounds |
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
|
| Change at 10 min in Systolic after 2nd dose |
|
| Baseline Diastolic |
|
| Change at 10 min in Diastolic after 1st dose |
|
| Change at 10 min in Diastolic after 2nd dose |
|
|
| Change from baseline at 14 mins post 2nd dose |
|