Methamphetamine Intoxication (Disorder)Phase 2Meth-ODNCT04715230
Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
A Phase 2 study testing IXT-m200, Lorazepam and Haloperidol in people with Methamphetamine Intoxication (Disorder), run by InterveXion Therapeutics, LLC at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Methamphetamine Intoxication (Disorder)
- What is being tested?
- IXT-m200, Lorazepam and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jun 2021to 14 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
Providence Regional Medical Center Everett
Everett, Washington, 98201
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
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.
- Conditions
- Methamphetamine Intoxication (Disorder)
- Being tested
- IXT-m200, Lorazepam, Haloperidol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXT-m200Biological
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.
LorazepamDrug
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
HaloperidolDrug
Haloperidol is commonly used to treat agitation due to psychosis.
| Study group | Role | What they receive |
|---|---|---|
| IXT-m200 | Experimental | 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. Receives: Biological: IXT-m200 |
| Treatment as Usual (TAU) | Active comparator | 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. Receives: Drug: Lorazepam; Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment-related Adverse Events (AEs) as Measured by Vital Signs
Blood pressure, heart rate, and temperature
Measured: 28 days
Number of Patients With Treatment-related AEs as Measured by Physical Examinations
Physical examinations
Measured: 28 days
Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
Clinical laboratory testing
Measured: 3 days
Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
Electrocardiogram
Measured: 4 hours
Secondary outcomes (5)
Time Course and Degree of Normalization of Agitation
Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES). The minimum value is 1 (highly agitated) and the highest value is 9 (completely sedated). A score of 3-5 is considered normal.
Measured: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Blood pressure over time; reported as the number of participants with blood pressure out of normal range (i.e., diastolic >110 or <50 mmHg, or systolic >180 or <90 mmHg))
Measured: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Heart rate over time reported as number of participants with heart rate high (>120 beats/min), normal, or low (<40 beats/min).
Measured: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Time Course and Degree of Normalization of Temperature
Temperature over time
Measured: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
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 (central nervous system toxicity)
- hypertension, tachycardia, or other cardiovascular instability (cardiovascular toxicity)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start30 Jun 2021
- Primary completion5 Oct 2022
- Study completion14 Nov 2022
Why it stopped: Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine Intoxication (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterveXion Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, InterveXion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715230
- Sponsor's protocol ID
- M200C-2101
- Other IDs
- U01DA053043
- Acronym
- Meth-OD
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2021
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets are expected to contain IXT-m200 and METH concentration data, ACES scores over time, and safety data. No individually identifiable private information will be distributes.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
- ClinicalTrials.gov ID
- NCT04715230
- Acronym / sponsor ID
- Meth-OD / M200C-2101
- Conditions
- Methamphetamine Intoxication (Disorder)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InterveXion Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IXT-m200 | Experimental | Biological: IXT-m200IXT-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. |
| Treatment as Usual (TAU) | Active comparator | Drug: Lorazepam, Drug: HaloperidolLorazepam 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXT-m200IXT-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. | Biological | IXT-m200 |
| LorazepamLorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting. | Drug | Treatment as Usual (TAU) |
| HaloperidolHaloperidol is commonly used to treat agitation due to psychosis. | Drug | Treatment as Usual (TAU) |
Primary outcome
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
5 secondary outcomes
Time Course and Degree of Normalization of Agitation
Time frame: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Time frame: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Time frame: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Time Course and Degree of Normalization of Temperature
Time frame: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Final datasets are expected to contain IXT-m200 and METH concentration data, ACES scores over time, and safety data. No individually identifiable private information will be distributes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
InterveXion Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IXT-m200, Lorazepam and Haloperidol in people with Methamphetamine Intoxication (Disorder), run by InterveXion Therapeutics, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Treatment-related Adverse Events (AEs) as Measured by Vital Signs (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.