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Trial record 1 of 1 for:    NCT04715230
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Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (Meth-OD)

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ClinicalTrials.gov Identifier: NCT04715230
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
InterveXion Therapeutics, LLC

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.


Condition or disease Intervention/treatment Phase
Methamphetamine Intoxication (Disorder) Biological: IXT-m200 Drug: Lorazepam Drug: Haloperidol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: IXT-m200
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.
Biological: 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.

Active Comparator: Treatment as Usual (TAU)
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.
Drug: Lorazepam
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.

Drug: Haloperidol
Haloperidol is commonly used to treat agitation due to psychosis.




Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events (AEs) as measured by vital signs [ Time Frame: 28 days ]
    Blood pressure, heart rate, and temperature

  2. Number of patients with treatment-related AEs as measured by physical examinations [ Time Frame: 28 days ]
    Physical examinations

  3. Number of patients with treatment-related AEs as measured by clinical laboratory testing [ Time Frame: 3 days ]
    Clinical laboratory testing

  4. Number of patients with treatment-related AEs as measured by electrocardiogram [ Time Frame: 4 hours ]
    Electrocardiogram


Secondary Outcome Measures :
  1. Time course and degree of normalization of agitation [ Time Frame: 8 hours ]
    Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES)

  2. Time course and degree of normalization of blood pressure [ Time Frame: 8 hours ]
    Blood pressure over time

  3. Time course and degree of normalization of heart rate [ Time Frame: 8 hours ]
    Heart rate over time

  4. Time course and degree of normalization of temperature [ Time Frame: 8 hours ]
    Temperature over time

  5. Number of participants requiring rescue medications for psychiatric or cardiovascular manifestations of METH toxicity [ Time Frame: 8 hours ]

    Number of participants that need rescue medications to treat:

    • agitation, dysphoria, or psychosis (CNS toxicity)
    • hypertension, tachycardia, or other cardiovascular instability (CV toxicity)


Other Outcome Measures:
  1. Length of patient stay in the ED [ Time Frame: 8 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715230


Contacts
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Contact: Chief Operating Officer 5015542377 misty.stevens@intervexion.com

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Quidusiyyah Gaffoor    501-214-2193    QRGaffoor@uams.edu   
Principal Investigator: Michael Wilson, MD         
United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Cameron Crandall, MD    505-272-5062    ccrandall@salud.unm.edu   
Principal Investigator: Cameron Crandall, MD         
United States, Washington
Providence Regional Medical Center Everett Recruiting
Everett, Washington, United States, 98201
Contact: Katie Sanders    425-261-4069      
Principal Investigator: Thomas Robey, MD, PhD         
Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: David McClellan, MD    509-474-4345      
Principal Investigator: David McClellan, MD         
Sponsors and Collaborators
InterveXion Therapeutics, LLC
National Institute on Drug Abuse (NIDA)
Investigators
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Study Director: Chief Medical Officer InterveXion Therapeutics
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Responsible Party: InterveXion Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04715230    
Other Study ID Numbers: M200C-2101
U01DA053043 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Lorazepam
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Anticonvulsants
Hypnotics and Sedatives
Anti-Anxiety Agents
GABA Modulators
GABA Agents