Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (OUTLAST)

September 24, 2024 updated by: InterveXion Therapeutics, LLC

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 in Treatment-Seeking Individuals With Methamphetamine Use Disorder

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research
      • Little Rock, Arkansas, United States, 72211
        • Woodlands International Research Group
    • California
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Illinois
      • Lincolnwood, Illinois, United States, 60712
        • Pillar Clinical Research
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Texas
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77008
        • HD Research
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research
    • Utah
      • Clinton, Utah, United States, 84015
        • Alpine Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Eligible participants will:

  1. Be at least 18 years of age at the time of study consent;
  2. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Substance Use Disorder associated with methamphetamine;
  3. Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period;
  4. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
  5. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
  6. Agree to use protocol-specified method(s) of birth control throughout study participation;
  7. Agree to adhere to Lifestyle Considerations throughout study duration;
  8. Have access to a smartphone or other device capable of supporting the study app;
  9. Successfully complete app-based training program as evidenced by completion of at least 75% of daily drug use surveys and assigned saliva drug screens (two of which must be valid) in ≤30 days from the screening visit during the screening period.

Eligible participants will NOT:

  1. Have current dependence, defined by DSM-5 criteria, on any psychoactive substance (i.e., opioids or benzodiazepines), other than methamphetamine or nicotine (any severity). Mild severity dependence on alcohol or marijuana is allowed;
  2. Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);
  3. Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other monoclonal antibodies, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
  4. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;
  5. Have a history of allergic or environmental bronchial asthma within the past 3 years;
  6. Have a current diagnosis of anorexia nervosa or bulimia disorder;
  7. Have a history of unstable cardiovascular disease that is not adequately controlled at the time of eligibility determination;
  8. Be mandated by the court to obtain treatment for methamphetamine-dependence where such mandate required the results of methamphetamine testing to be reported to the court;
  9. Have positive saliva drug screens for psychoactive substances other than amphetamines at the screening visit;
  10. Be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area, or any clinically significant mental or physical illness within a 1-year prior, that would impact compliance with trial requirements;

  11. Have clinically significant laboratory values (outside of normal limits). The following specified ranges are allowable:

    1. Liver function tests (total, direct, and indirect bilirubin, aspartate transaminase, alanine aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase, and alkaline phosphatase) <3 times the upper limit of normal, and
    2. Kidney function tests (creatinine and BUN) <2 times the upper limit of normal;
  12. Be considered to be at imminent risk of suicide or have a past-year history of a serious suicide attempt (defined as an attempt that results in or requires medical treatment) based on response to queries within eligibility screening about suicidal ideation and attempts;
  13. Have an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results;
  14. Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;
  15. Be pregnant or lactating;
  16. In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study, including those believed to be attempting to enter the study primarily for financial gain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Saline
Other: Placebo
Saline
Experimental: IXT-m200
Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g
Drug: IXT-m200
IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period
Time Frame: 20 weeks
The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.
Time Frame: Weeks 13, 25, and 33
Treatment Effectiveness Assessment (TEA) asks questions in four domains with results ranging from 4-40 with higher scores representing a better outcome.
Weeks 13, 25, and 33
Proportion of Responders in Early Remission at Week 25 as Measured by DSM-5 Criteria
Time Frame: 25 weeks
A responder is defined as a participant who meets the definition of early remission, i.e., at least 3 months and <12 months without meeting DSM-5 criteria other than craving.
25 weeks
Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33
Time Frame: Weeks 13, 25, and 33
The CGIC asks clinicians to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
Weeks 13, 25, and 33
Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33
Time Frame: Weeks 13, 25, and 33
The PGIC asks patients to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
Weeks 13, 25, and 33

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of sequential weeks of abstinence from the end of treatment
Time Frame: 25 weeks
Saliva screens and by self-report
25 weeks
Point prevalence abstinence (last 7 days)
Time Frame: 33 weeks
Saliva screens and by self-report
33 weeks
Weekly abstinence from stimulants following a 4-week grace period
Time Frame: 25 weeks
Saliva screens
25 weeks
Proportion of responders with reduced DSM-5 criteria at Week 33 as measured by DSM-5 criteria
Time Frame: 33 weeks
A responder is defined as a participant who meets a reduced number of DSM-5 criteria for MUD over the past month compared to Screening
33 weeks
Proportion of responders in early remission at Week 33 as measured by DSM-5 criteria
Time Frame: 33 weeks
A responder is defined as a participant who meets the definition of early remission, i.e., at least 3 months and <12 months without meeting DSM-5 criteria other than craving.
33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InterveXion Therapeutics, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chief Medical Officer, InterveXion Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M200C-2201
  • U01DA055481 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Final datasets are expected to contain IXT-m200 concentrations and immunogenicity results, METH use frequencies, Treatment Effectiveness Assessment scores, and safety data over time. No individually identifiable private information will be distributed.

IPD Sharing Time Frame

These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.

IPD Sharing Access Criteria

These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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