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MN-221

Phase 2

Asthma | Small molecule | Respiratory |MediciNova, Inc.|Trials Updated: May 13, 2015

MN-221 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since May 2008

MN-221 target and mechanism

ModalitySmall molecule

Also known as MN-221 (Dose Group 1), Bedoradrine Sulfate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment260

FDA Designations

No designations recorded

MN-221 clinical trials

MN-221 · 4 trials · 2 indications

Phase 2 2Phase 1 2
NCT00838591Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of AsthmaAsthma
COMPLETED176 Analytics
NCT00679263Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe AsthmaAsthma
COMPLETED17 Analytics
PHASE2COMPLETED
Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of Asthma
AsthmaUnlock trial analytics
PHASE2COMPLETED
Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint.
Hour 3
Number of Patients Reported to Have Adverse Events
Day 1 to Day 2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Treatment Days 1- 5

The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.

Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.
Hour 0 (treatment) through Hour 24 (follow-up)

Secondary Endpoints

Change from baseline FEV1 % of predicted (at time points other than Hour 3)
Hours 1, 2, 3, and 24
Change from baseline FEV1 (L)
Hours 1, 2, 3 and 24
Change from baseline PEFR (L/sec)
Hours 1, 2, 3 and 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMN-221 given i.v. 1-hour infusion a total dose of 1200 μg (40 μg/min for 15 min \[600 μg\] + 13.3 μg/min for 45 min \[600 μg\]) as an adjunct to the standard of care for acute exacerbation of asthma.
PlaceboPLACEBO_COMPARATORPlacebo (Lot #CLO-095) was packaged in identical vials containing only excipients and administered as an i.v. 1-hour infusion with a regimen as described for MN-221.
MN-221EXPERIMENTAL -
MN-221 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MN-221DRUGDose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
PlaceboDRUG -
MN-221 (Dose Group 1)DRUGi.v. infusion of MN-221 (300 mcg) or placebo over 1 hour
MN-221 (Dose Group 2)DRUGi.v. infusion of MN-221 (600 mcg) or placebo over 1 hour
MN-221 (Dose Group 3)DRUGi.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Subjects meeting all of the following criteria will be considered for admission to the study: 1. Male or female 18 to 65 years of age, inclusive; 2. Self-reported history of physician-diagnosed and treated asthma for ≥ 3 months prior to randomization; 3. A diagnosis of ...

Countries:United States
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Frequently asked questions about MN-221

What is MN-221 used for?

MN-221 is an investigational small molecule being studied for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It has been evaluated both as an adjunct to standard therapy during acute asthma exacerbations and for safety in patients with stable moderate to severe COPD.

Who is developing MN-221?

MN-221 is being developed by MediciNova, Inc., a biopharmaceutical company that trades under the ticker symbol MNOV. MediciNova has sponsored the clinical trial programs evaluating MN-221 in asthma and COPD patient populations in the United States.

What phase is MN-221 in?

MN-221 is in Phase 2 clinical development. It has completed Phase 2 trials in asthma and Phase 1 trials in COPD. MN-221 is investigational and has not been approved by the FDA for any indication.

What clinical trials is MN-221 in?

MN-221 has been studied in completed trials including NCT00838591 and NCT00679263 in asthma, and NCT01551316 and NCT01013142 in COPD. These trials enrolled a combined total of 260 participants across the asthma and COPD programs.

Is MN-221 the same as MN-221 (Dose Group 1)?

Yes, MN-221 (Dose Group 1) refers to a specific dose cohort within the MN-221 clinical development program. MN-221 is the base compound name, and Dose Group 1 identifies a particular dosing arm studied in its trials.