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Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (Meth-OD)

Primary Purpose

Methamphetamine Intoxication (Disorder)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IXT-m200
Lorazepam
Haloperidol
Sponsored by
InterveXion Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methamphetamine Intoxication (Disorder)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be aged 18 to 45 years, inclusive;
  2. Present to the ED with METH toxicity as defined in protocol;
  3. Have a PANSS-EC score of 14-28, inclusive;
  4. Have or agrees to have an intravenous (IV) line placed;
  5. Give a history of METH use in the past 24 hours, with participant or observer attribution of symptoms to METH, or have a positive METH drug screen;
  6. Be accompanied or readily represented by a legally authorized representative (surrogate) who can consent to participation on behalf of the participant; and
  7. Assent to participation in the study.

Exclusion Criteria:

  1. Present with concomitant opioid overdose requiring ventilatory support;
  2. Be self-reported to be pregnant or lactating;
  3. Be considered to have significant concomitant medical illness or trauma, or symptoms of severe METH toxicity including

    1. sepsis or febrile illness;
    2. myocardial infarction, cardiac decompensation or arrhythmias including tachycardia that is not sinus; severe hypertension (>180/110 mmHg); inadequately treated hypertension on chronic medication; history of vasculitis
    3. coma, stroke or severe head injury; new or ongoing seizure activity
    4. acute pulmonary decompensation or severe chronic obstructive pulmonary disease;
    5. any hepatic impairment and/or acute hepatitis or renal impairment due to concomitant medical illness; or
    6. current, or history of, neuroleptic malignant syndrome
  4. Be considered to be at imminent risk of suicide or have disqualifying answers to the following two questions. Disqualifying answers would be 1b2 or 2b. 1. In the past 30 days, have you considered killing yourself? a) No; b) Yes - if Yes, how often? b1) Not often (twice or less), b2) Somewhat often (more than twice). 2. In the past year, have you attempted to kill yourself? a) No; b) Yes;
  5. Be considered to be at imminent risk of injury or danger to self, others or property;
  6. Have a history of severe allergy (rash, hives, breathing difficulty, etc.), known hypersensitivity or infusion reaction to any antibody medications, lorazepam or haloperidol; or
  7. Be judged by the treating ED physician, investigator, or Sponsor (or designee) to be inappropriate for the study, including people whom the investigator determines cannot reasonably be consulted for assent to participation.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • University of New Mexico Hospital
  • Providence Regional Medical Center Everett
  • Sacred Heart Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IXT-m200

Treatment as Usual (TAU)

Arm Description

IXT-m200 is a high-affinity chimeric anti-METH monoclonal antibody that is well-tolerated in healthy volunteers and in non-intoxicated people with METH use disorder. The total dose will be given over 10 min for the 0.5-g dose and over 20 min for the 1-, 1.5-, and 2-g doses.

Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting. Haloperidol is commonly used to treat agitation due to psychosis.

Outcomes

Primary Outcome Measures

Number of patients with treatment-related adverse events (AEs) as measured by vital signs
Blood pressure, heart rate, and temperature
Number of patients with treatment-related AEs as measured by physical examinations
Physical examinations
Number of patients with treatment-related AEs as measured by clinical laboratory testing
Clinical laboratory testing
Number of patients with treatment-related AEs as measured by electrocardiogram
Electrocardiogram

Secondary Outcome Measures

Time course and degree of normalization of agitation
Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES)
Time course and degree of normalization of blood pressure
Blood pressure over time
Time course and degree of normalization of heart rate
Heart rate over time
Time course and degree of normalization of temperature
Temperature over time
Number of participants requiring rescue medications for psychiatric or cardiovascular manifestations of METH toxicity
Number of participants that need rescue medications to treat: agitation, dysphoria, or psychosis (CNS toxicity) hypertension, tachycardia, or other cardiovascular instability (CV toxicity)

Full Information

First Posted
January 13, 2021
Last Updated
January 5, 2023
Sponsor
InterveXion Therapeutics, LLC
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04715230
Brief Title
Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Acronym
Meth-OD
Official Title
Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InterveXion Therapeutics, LLC
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis of this multisite Phase 2a study is that IXT-m200 will be well-tolerated in patients with acute mild to moderate METH toxicity. A randomized, open label design will be used in which one dose of IXT-m200 will be compared to treatment-as-usual (TAU). Approximately 40 participants will be enrolled in 4 cohorts. A dose escalation approach will be used so that progressively higher IXT-m200 doses will be evaluated in each cohort. In conjunction with safety monitoring, this design assures the opportunity to observe early safety findings before any participants are exposed to the next higher dose. The randomization ratio for IXT-m200 versus TAU is defined as 4:1 for each cohort so that the number of participants receiving TAU equals the number receiving each dose of IXT-m200 at the end of the study. Agitation scales and vital signs will be recorded to track effect of the antibody treatment versus TAU over time on agitation associated with METH use. While in the emergency department (ED), detailed and pertinent medical and psychiatric histories, and physical exam will be obtained, along with laboratory assessments and ECGs. In the ED, participants will give blood samples for analysis of METH and IXT-m200 concentrations and followed for development of adverse events. Participants will be evaluated at 2 days and 4 weeks after discharge from the ED for adverse events and drug use history. Cohort escalation reviews will be performed by the Sponsor, Medical Monitor, and Data and Safety Monitoring Board (DSMB) between cohorts and the next group will not start until after completion of this review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine Intoxication (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IXT-m200
Arm Type
Experimental
Arm Description
IXT-m200 is a high-affinity chimeric anti-METH monoclonal antibody that is well-tolerated in healthy volunteers and in non-intoxicated people with METH use disorder. The total dose will be given over 10 min for the 0.5-g dose and over 20 min for the 1-, 1.5-, and 2-g doses.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting. Haloperidol is commonly used to treat agitation due to psychosis.
Intervention Type
Biological
Intervention Name(s)
IXT-m200
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Intervention Description
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Haloperidol is commonly used to treat agitation due to psychosis.
Primary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events (AEs) as measured by vital signs
Description
Blood pressure, heart rate, and temperature
Time Frame
28 days
Title
Number of patients with treatment-related AEs as measured by physical examinations
Description
Physical examinations
Time Frame
28 days
Title
Number of patients with treatment-related AEs as measured by clinical laboratory testing
Description
Clinical laboratory testing
Time Frame
3 days
Title
Number of patients with treatment-related AEs as measured by electrocardiogram
Description
Electrocardiogram
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Time course and degree of normalization of agitation
Description
Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES)
Time Frame
8 hours
Title
Time course and degree of normalization of blood pressure
Description
Blood pressure over time
Time Frame
8 hours
Title
Time course and degree of normalization of heart rate
Description
Heart rate over time
Time Frame
8 hours
Title
Time course and degree of normalization of temperature
Description
Temperature over time
Time Frame
8 hours
Title
Number of participants requiring rescue medications for psychiatric or cardiovascular manifestations of METH toxicity
Description
Number of participants that need rescue medications to treat: agitation, dysphoria, or psychosis (CNS toxicity) hypertension, tachycardia, or other cardiovascular instability (CV toxicity)
Time Frame
8 hours
Other Pre-specified Outcome Measures:
Title
Length of patient stay in the ED
Description
ED length of stay as measured by disposition order time minus triage time, and as measured by disposition order time minus start of treatment time, with log transformation
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be aged 18 to 45 years, inclusive; Present to the ED with METH toxicity as defined in protocol; Have a PANSS-EC score of 14-28, inclusive; Have or agrees to have an intravenous (IV) line placed; Give a history of METH use in the past 24 hours, with participant or observer attribution of symptoms to METH, or have a positive METH drug screen; Be accompanied or readily represented by a legally authorized representative (surrogate) who can consent to participation on behalf of the participant; and Assent to participation in the study. Exclusion Criteria: Present with concomitant opioid overdose requiring ventilatory support; Be self-reported to be pregnant or lactating; Be considered to have significant concomitant medical illness or trauma, or symptoms of severe METH toxicity including sepsis or febrile illness; myocardial infarction, cardiac decompensation or arrhythmias including tachycardia that is not sinus; severe hypertension (>180/110 mmHg); inadequately treated hypertension on chronic medication; history of vasculitis coma, stroke or severe head injury; new or ongoing seizure activity acute pulmonary decompensation or severe chronic obstructive pulmonary disease; any hepatic impairment and/or acute hepatitis or renal impairment due to concomitant medical illness; or current, or history of, neuroleptic malignant syndrome Be considered to be at imminent risk of suicide or have disqualifying answers to the following two questions. Disqualifying answers would be 1b2 or 2b. 1. In the past 30 days, have you considered killing yourself? a) No; b) Yes - if Yes, how often? b1) Not often (twice or less), b2) Somewhat often (more than twice). 2. In the past year, have you attempted to kill yourself? a) No; b) Yes; Be considered to be at imminent risk of injury or danger to self, others or property; Have a history of severe allergy (rash, hives, breathing difficulty, etc.), known hypersensitivity or infusion reaction to any antibody medications, lorazepam or haloperidol; or Be judged by the treating ED physician, investigator, or Sponsor (or designee) to be inappropriate for the study, including people whom the investigator determines cannot reasonably be consulted for assent to participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
InterveXion Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose

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