Trial Outcomes & Findings for Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma (NCT NCT00679263)
NCT ID: NCT00679263
Last Updated: 2011-12-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Day 1 to Day 2
Results posted on
2011-12-19
Participant Flow
Subjects diagnosed with moderate to severe asthma in stable status were recruited at clinic
Subjects were screened for eligibility and must have demonstrated an improvement in forced expiratory volume in 1 second (FEV1) of at least 12% and 200 cc at the Screen Visit after bronchodilator treatment compared to pre-bronchodilator use. Continued eligibility was determined for each subject prior to administering each dose.
Participant milestones
| Measure |
MN-221 1-hour Infusion
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
|---|---|---|---|
|
Visit 3/Dose 2
STARTED
|
10
|
11
|
11
|
|
Visit 3/Dose 2
COMPLETED
|
9
|
6
|
11
|
|
Visit 3/Dose 2
NOT COMPLETED
|
1
|
5
|
0
|
|
Visit 2/Dose 1
STARTED
|
11
|
6
|
11
|
|
Visit 2/Dose 1
COMPLETED
|
9
|
5
|
11
|
|
Visit 2/Dose 1
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
MN-221 1-hour Infusion
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
|---|---|---|---|
|
Visit 2/Dose 1
Adverse Event
|
1
|
0
|
0
|
|
Visit 2/Dose 1
subject not compliance
|
1
|
1
|
0
|
Baseline Characteristics
Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
Baseline characteristics by cohort
| Measure |
MN-221 1-hour Infusion
n=11 Participants
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
n=6 Participants
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
n=11 Participants
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
30.5 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 10.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 2Outcome measures
| Measure |
MN-221 1-hour Infusion
n=11 Participants
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
n=6 Participants
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
n=11 Participants
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
|---|---|---|---|
|
Number of Patients Reported to Have Adverse Events
|
11 participants
|
6 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 2The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.
Outcome measures
| Measure |
MN-221 1-hour Infusion
n=11 Participants
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
n=6 Participants
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
n=11 Participants
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
|---|---|---|---|
|
FEV1 Percent Predicted Changes From Base Line
|
17.48 FEV1 percent predicted
Standard Deviation 10.19
|
1.85 FEV1 percent predicted
Standard Deviation 9.45
|
8.95 FEV1 percent predicted
Standard Deviation 9.2
|
Adverse Events
MN-221 1-hour Infusion
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MN-221 2-hour Infusion
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MN-221 1-hour Infusion
n=11 participants at risk
30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
|
Placebo
n=6 participants at risk
MN-221 Placebo continuous infusion
|
MN-221 2-hour Infusion
n=11 participants at risk
16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
|
|---|---|---|---|
|
Nervous system disorders
headache
|
27.3%
3/11 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
18.2%
2/11 • Number of events 3
|
|
Nervous system disorders
tremor
|
45.5%
5/11 • Number of events 5
|
0.00%
0/6
|
54.5%
6/11 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.2%
2/11 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
36.4%
4/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/11
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
|
Vascular disorders
Flushing
|
0.00%
0/11
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Vision Blurred
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/11
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
0.00%
0/6
|
18.2%
2/11 • Number of events 2
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/11
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Sinus Tachycardia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
|
Cardiac disorders
Electrocardiogram T wave inversion
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Electrocardiogram T wave amplitude decreased
|
0.00%
0/11
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Electrocardiogram ST segment depression
|
0.00%
0/11
|
16.7%
1/6 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Electrocardiogram QT prolonged
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
9.1%
1/11 • Number of events 2
|
Additional Information
Kazuko Matsuda, MD, Vice President Clinical Development
Medicinova Inc
Phone: 858-373-1500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60