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Trial record 26 of 36 for:    "Status Asthmaticus"

Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00683449
Recruitment Status : Terminated (Data from Dose Groups 1,2 and other MN-221 studies resulted in the determination of a more appropriate dosing scheme for MN-221 in subjects with asthma.)
First Posted : May 23, 2008
Results First Posted : July 29, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
MediciNova

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Asthma
Status Asthmaticus
Interventions Drug: Dose Group 1
Drug: MN-221 placebo
Drug: Dose Group 2
Drug: Dose Group 3
Enrollment 29
Recruitment Details Upon presentation to the Emergency Department (ED) at a hospital participating in the study with an acute exacerbation of asthma, the Principal Investigator (ED physician) discussed the study with the potential subject.
Pre-assignment Details Some subjects were consented for the study, but upon screening, failed to meet the inclusion and exclusion criteria, had an FEV1 > 50%, or refused to participate.
Arm/Group Title 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Hide Arm/Group Description

Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:

  • Assessment of subject’s signs and symptoms
  • Completion of a dyspnea index scale
  • Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
  • Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subj

MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.

  • Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group. 30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v. Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
Period Title: Overall Study
Started 5 13 3 6 2
Completed 5 12 3 6 2
Not Completed 0 1 0 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0             0
Arm/Group Title 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes Total
Hide Arm/Group Description

Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:

  • Assessment of subject’s signs and symptoms
  • Completion of a dyspnea index scale
  • Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
  • Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subj

MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.

  • Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group. 30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v. Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion. Total of all reporting groups
Overall Number of Baseline Participants 5 13 3 6 2 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 3 participants 6 participants 2 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
13
 100.0%
3
 100.0%
6
 100.0%
2
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 13 participants 3 participants 6 participants 2 participants 29 participants
30.2  (11.56) 42.6  (9.7) 22.3  (3.21) 39.2  (9.77) 45  (0.0) 37.83  (11.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 3 participants 6 participants 2 participants 29 participants
Female
3
  60.0%
7
  53.8%
3
 100.0%
6
 100.0%
2
 100.0%
21
  72.4%
Male
2
  40.0%
6
  46.2%
0
   0.0%
0
   0.0%
0
   0.0%
8
  27.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 13 participants 3 participants 6 participants 2 participants 29 participants
5 13 3 6 2 29
1.Primary Outcome
Title Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.
Hide Description The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.
Time Frame Baseline and Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.
Arm/Group Title 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Hide Arm/Group Description:

Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:

  • Assessment of subject’s signs and symptoms
  • Completion of a dyspnea index scale
  • Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
  • Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subj

MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.

  • Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
Overall Number of Participants Analyzed 5 13 3 6 2
Mean (Full Range)
Unit of Measure: FEV1 (percent of predicted)
16.57
(4.8 to 44.7)
3.88
(-13.2 to 19.9)
3.03
(-0.4 to 6.0)
4.27
(-3.3 to 11.9)
-0.82
(-2.4 to 0.8)
2.Secondary Outcome
Title FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.
Hide Description FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.
Time Frame Baseline to Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.
Arm/Group Title MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg) Placebo Administered Intravenously 450 μg MN-221 Given i.v. 1,000-1,080 μg MN-221 Given i.v. for 15 Minutes 1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes
Hide Arm/Group Description:
The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
Overall Number of Participants Analyzed 5 13 6 3 2
Mean (Full Range)
Unit of Measure: liters per second
0.60
(0.14 to 1.67)
0.10
(-0.51 to 0.54)
0.12
(-0.09 to 0.33)
0.10
(-0.02 to 0.22)
-0.02
(-0.07 to 0.02)
3.Secondary Outcome
Title Hospital Admission Rate During Visit 1
Hide Description After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.
Time Frame Hour -1.5 through Hour 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Hide Arm/Group Description:

Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:

  • Assessment of subject’s signs and symptoms
  • Completion of a dyspnea index scale
  • Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
  • Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subj

MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.

  • Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
Overall Number of Participants Analyzed 5 13 3 6 2
Measure Type: Number
Unit of Measure: participants
0 7 0 3 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Hide Arm/Group Description

Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:

  • Assessment of subject’s signs and symptoms
  • Completion of a dyspnea index scale
  • Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
  • Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subj

MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.

  • Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
  • Spirometry completed within 10 minutes of nebulizer treatments, followed by
  • Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group. 30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v. Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
All-Cause Mortality
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      4/13 (30.77%)      0/3 (0.00%)      1/6 (16.67%)      1/2 (50.00%)    
Respiratory, thoracic and mediastinal disorders           
Exacerbation of asthma * 1  0/5 (0.00%)  0 4/13 (30.77%)  4 0/3 (0.00%)  0 1/6 (16.67%)  1 1/2 (50.00%)  1
Pneumonia  [1]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
[1]
Laboratory results were significant for elevated white blood cell count of 28,000 cells/microliter.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes MN-221 Placebo i.v. Infusion 1,000-1,080 μg MN-221 i.v. 450 μg MN-221 i.v. for 15 Minutes 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      6/13 (46.15%)      0/3 (0.00%)      1/6 (16.67%)      2/2 (100.00%)    
Blood and lymphatic system disorders           
Monocyte count decreased  1  2/5 (40.00%)  2 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Cardiac disorders           
Tachycardia  1  0/5 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorders           
Abdominal Distention  1  0/5 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Abdominal Pain  1  0/5 (0.00%)  0 0/13 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Abdominal pain upper  1  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations           
Pneumonia  1  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Nasopharyngitis  1  1/5 (20.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Investigations           
Lymphocyte count decreased  1  2/5 (40.00%)  4 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Blood lactic acid increased  1  2/5 (40.00%)  2 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Blood potassium decreased  1  3/5 (60.00%)  3 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Blood bicarbonate decreased  1  1/5 (20.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders           
Hypercalcemia  2  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Hyperglycemia  1  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Muscle spasms  1  1/5 (20.00%)  1 0/13 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders           
Headache  1  0/5 (0.00%)  0 1/13 (7.69%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  3/5 (60.00%)  19 6/13 (46.15%)  12 0/3 (0.00%)  0 1/6 (16.67%)  3 2/2 (100.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
2
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kazuko Matsuda, MD PhD MPH, Vice President, Clinical Development
Organization: MediciNova, Inc.
Phone: 858-373-1500 ext 132
Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT00683449     History of Changes
Other Study ID Numbers: MN-221-CL-006
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: February 16, 2011
Results First Posted: July 29, 2011
Last Update Posted: October 7, 2011