Trial Outcomes & Findings for QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo (NCT NCT01191723)
NCT ID: NCT01191723
Last Updated: 2014-01-09
Results Overview
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
COMPLETED
PHASE1
54 participants
baseline and 30 minutes
2014-01-09
Participant Flow
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.
Participant milestones
| Measure |
Treatment A, Then B, Then C
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4.
|
Treatment A, Then C, Then B
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4.
|
Treatment B, Then A, Then C
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4.
|
Treatment B, Then C, Then A
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
|
Treatment C, Then A, Then B
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4.
|
Treatment C, Then B, Then A
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
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|---|---|---|---|---|---|---|
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Overall Study
STARTED
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9
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9
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9
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9
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9
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9
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Overall Study
COMPLETED
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9
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9
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9
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9
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9
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9
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Baseline characteristics by cohort
| Measure |
All Subjects
n=54 Participants
All subjects enrolled in the study.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 30 minutesPopulation: Patients with data available at required time point were included in the analysis population.
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Outcome measures
| Measure |
Treatment C (Placebo)
n=52 Participants
Treatment C = inhaler placebo and placebo capsules.
|
Treatment B (MAP0004 3.0mg)
n=54 Participants
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
Treatment A (Moxifloxacin)
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
|
|---|---|---|---|
|
Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
Change from Baseline at 30 mins
|
-4.7 milliseconds
Standard Deviation 6.2
|
-4.6 milliseconds
Standard Deviation 7.3
|
—
|
|
Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
Baseline
|
408.8 milliseconds
Standard Deviation 20.1
|
409.6 milliseconds
Standard Deviation 20.9
|
—
|
PRIMARY outcome
Timeframe: baseline and 2 hoursPopulation: Patients with data available at required time point were included in the analysis population.
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Outcome measures
| Measure |
Treatment C (Placebo)
n=52 Participants
Treatment C = inhaler placebo and placebo capsules.
|
Treatment B (MAP0004 3.0mg)
n=54 Participants
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
Treatment A (Moxifloxacin)
n=54 Participants
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
|
|---|---|---|---|
|
Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Baseline
|
408.8 milliseconds
Standard Deviation 20.1
|
409.6 milliseconds
Standard Deviation 20.9
|
408.6 milliseconds
Standard Deviation 20.0
|
|
Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Change from Baseline at 2 hours
|
-2.3 milliseconds
Standard Deviation 7.0
|
-5.1 milliseconds
Standard Deviation 6.7
|
9.0 milliseconds
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: baseline and 30 minutesPopulation: Patients with data available at required time point were included in the analysis population.
The Fridericia corrected QT interval(QTcF) 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.
Outcome measures
| Measure |
Treatment C (Placebo)
n=52 Participants
Treatment C = inhaler placebo and placebo capsules.
|
Treatment B (MAP0004 3.0mg)
n=54 Participants
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
Treatment A (Moxifloxacin)
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
|
|---|---|---|---|
|
Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes
Baseline
|
406.8 milliseconds
Standard Deviation 18.4
|
407.7 milliseconds
Standard Deviation 20.0
|
—
|
|
Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes
Change from Baseline at 30 mins
|
-5.0 milliseconds
Standard Deviation 6.4
|
-4.7 milliseconds
Standard Deviation 6.7
|
—
|
SECONDARY outcome
Timeframe: baseline and 2 hoursPopulation: Patients with data available at required time point were included in the analysis population.
The Fridericia corrected QT interval(QTcF) 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.
Outcome measures
| Measure |
Treatment C (Placebo)
n=52 Participants
Treatment C = inhaler placebo and placebo capsules.
|
Treatment B (MAP0004 3.0mg)
n=54 Participants
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
Treatment A (Moxifloxacin)
n=54 Participants
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
|
|---|---|---|---|
|
Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Baseline
|
406.8 milliseconds
Standard Deviation 18.4
|
407.7 milliseconds
Standard Deviation 20.0
|
407.0 milliseconds
Standard Deviation 18.7
|
|
Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Change from Baseline at 2 hours
|
-1.8 milliseconds
Standard Deviation 6.9
|
-3.9 milliseconds
Standard Deviation 6.0
|
8.5 milliseconds
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: baseline, 30 minutes, and 2 hoursPopulation: Patients with data available at required time point were included in the analysis population.
The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.
Outcome measures
| Measure |
Treatment C (Placebo)
n=52 Participants
Treatment C = inhaler placebo and placebo capsules.
|
Treatment B (MAP0004 3.0mg)
n=54 Participants
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
Treatment A (Moxifloxacin)
n=54 Participants
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
Baseline
|
64.1 beats per minute (bpm)
Standard Deviation 9.1
|
64.6 beats per minute (bpm)
Standard Deviation 9.5
|
63.8 beats per minute (bpm)
Standard Deviation 9.5
|
|
Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
Change from Baseline at 30 minutes
|
1.0 beats per minute (bpm)
Standard Deviation 4.2
|
-0.2 beats per minute (bpm)
Standard Deviation 5.8
|
2.4 beats per minute (bpm)
Standard Deviation 4.1
|
|
Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
Change from Baseline at 2 hours
|
-2.1 beats per minute (bpm)
Standard Deviation 4.3
|
-4.4 beats per minute (bpm)
Standard Deviation 6.7
|
0.3 beats per minute (bpm)
Standard Deviation 5.2
|
Adverse Events
Treatment C (Placebo)
Treatment B (MAP0004 3.0mg)
Treatment A (Moxifloxacin)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment C (Placebo)
n=54 participants at risk
Treatment C = inhaler placebo and placebo capsules
|
Treatment B (MAP0004 3.0mg)
n=54 participants at risk
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
|
Treatment A (Moxifloxacin)
n=54 participants at risk
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
27.8%
15/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
3.7%
2/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
7.4%
4/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
9.3%
5/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
7.4%
4/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Headache
|
3.7%
2/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
18.5%
10/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
3.7%
2/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.6%
3/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/54
Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
Additional Information
VP, Scientific Affairs
MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER