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MN-166 First

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

MN-166 First clinical trials

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 being studied for opioid abuse and opioid dependence. It was evaluated in a Phase 2 trial of 28 participants that examined oxycodone self-administration in people with opioid abuse. The drug is a small molecule developed by MediciNova, Inc. and has not been approved for this use.

Who makes MN-166 First?

MN-166 First is developed by MediciNova, Inc., which trades on the Nasdaq under the ticker MNOV. The company is the sponsor of the clinical program evaluating the drug in opioid abuse and opioid dependence.

What phase is MN-166 First in?

MN-166 First is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study enrolled 28 participants and was randomized, double-blind, and placebo-controlled.

What clinical trials is MN-166 First in?

MN-166 First has been studied in one completed Phase 2 trial, NCT01740414, titled Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers. The trial enrolled 28 adults aged 21 and older in the United States and included participants with opioid abuse or opioid dependence.