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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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.
- Number of patients with treatment-related adverse events (AEs) as measured by vital signs [ Time Frame: 28 days ]Blood pressure, heart rate, and temperature
- Number of patients with treatment-related AEs as measured by physical examinations [ Time Frame: 28 days ]Physical examinations
- Number of patients with treatment-related AEs as measured by clinical laboratory testing [ Time Frame: 3 days ]Clinical laboratory testing
- Number of patients with treatment-related AEs as measured by electrocardiogram [ Time Frame: 4 hours ]Electrocardiogram
- 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)
- Time course and degree of normalization of blood pressure [ Time Frame: 8 hours ]Blood pressure over time
- Time course and degree of normalization of heart rate [ Time Frame: 8 hours ]Heart rate over time
- Time course and degree of normalization of temperature [ Time Frame: 8 hours ]Temperature over time
- 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)
- 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
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
|Contact: Chief Operating Officerfirstname.lastname@example.org|
|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 email@example.com|
|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|
|Study Director:||Chief Medical Officer||InterveXion Therapeutics|