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MN-166 First

Phase 2

Opioid Abuse | Small molecule | Psychiatry |MediciNova, Inc.|Last Updated: Aug 17, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

MN-166 First · 1 trial · 2 indications

Phase 2 1
NCT01740414Effects of Ibudilast on Oxycodone Self-administration in Opioid AbusersOpioid Abuse
COMPLETED28 Analytics
PHASE2COMPLETED
Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Opioid AbuseUnlock trial analytics

Study Endpoints

Primary Endpoints

Drug Self-administration Breakpoint
42 days

Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.

Secondary Endpoints

Positive Subjective Effects to Oxycodone
42 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
MN-166 (formerly AV411) FirstACTIVE_COMPARATORParticipants who began 14-day maintenance on MN-166 (50 mg) first, before switching to Placebo maintenance.
Placebo FirstPLACEBO_COMPARATORParticipants who began 14-day maintenance on Placebo first, before switching to MN-166 (50 mg) maintenance.

Interventions

NameTypeDescription
MN-166 (50 mg) FirstDRUGIn this arm of the study participants were first maintained on 50 mg MN-166 BID for approximately 14 days, and were then switched onto placebo maintenance. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo \& MN-166).
Placebo FirstDRUGThis arm of the study participants were first maintained on placebo for approximately 14 days, and were then switched onto 50mg MN-166 BID maintenance. . The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo \& MN-166).
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adults between the ages of 21 and 55 * Current opioid dependence according to DSM-IV criteria * currently not seeking treatment Exclusion Criteria: * Female patients that are currently pregnant, or breastfeeding. Lack of effective birth control. * Participants who have a pos...

Countries:United States
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Frequently asked questions about MN-166 First

What is MN-166 First used for?

MN-166 First is an investigational small molecule being studied for the treatment of opioid abuse. It is in Phase 2 clinical development for this indication. The drug is being developed by MediciNova, Inc. and has received Orphan Drug and Fast Track designations from the FDA.

How does MN-166 First work?

MN-166 First is a small molecule being developed for opioid abuse. The specific molecular target or mechanism of action has not been disclosed in available information. It is currently in Phase 2 clinical trials to evaluate its effects on opioid self-administration in opioid abusers.

Who makes MN-166 First?

MN-166 First is being developed by MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNOV. The company is conducting clinical research on this drug for the treatment of opioid abuse.

What phase is MN-166 First in?

MN-166 First is in Phase 2 clinical development for opioid abuse. It is an investigational drug and has not been approved by the FDA. The drug has received Orphan Drug and Fast Track designations, which are intended to expedite its development and review.

What clinical trials is MN-166 First in?

MN-166 First has one completed Phase 2 clinical trial, NCT01740414, titled 'Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers.' This randomized, double-blind, placebo-controlled study enrolled 28 participants in the United States and investigated the drug's effects on opioid abuse and dependence.

Is MN-166 First the same as ibudilast?

MN-166 First is also known as ibudilast, as indicated by the clinical trial title referencing ibudilast. The drug is being studied under the name MN-166 First for opioid abuse, and it is in Phase 2 development by MediciNova, Inc.