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Monoclonal Antibodies
Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (Meth-OD Trial)
Phase 2
Waitlist Available
Research Sponsored by InterveXion Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing IXT-m200, a new antibody treatment, on patients with mild to moderate methamphetamine poisoning. The treatment works by using antibodies to attach to methamphetamine, which may reduce its harmful effects. The study aims to see if this treatment is safe and effective. Vaccines and monoclonal antibodies for treatment of methamphetamine abuse are being tested.
Eligible Conditions
- Meth overdose
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment until discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment until discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
Number of Patients With Treatment-related AEs as Measured by Physical Examinations
+1 moreSecondary study objectives
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
+2 moreOther study objectives
Length of Patient Stay in the ED
Side effects data
From 2021 Phase 1 & 2 trial • 77 Patients • NCT0333686672%
Euphoric mood
44%
Palpitations
33%
Injection site pain
33%
Hypervigilance
33%
Headache
28%
Nausea
28%
Tachycardia
17%
Catheter site pain
17%
Feeling hot
17%
Hyperhidrosis
17%
Dry mouth
11%
Influenza like illness
11%
Vomiting
11%
Abdominal discomfort
11%
Tremor
6%
Gastroenteritis
6%
Vibratory sense increased
6%
Abdominal distension
6%
Vision blurred
6%
Feeling abnormal
6%
Haematuria
6%
Constipation
6%
Dizziness
6%
Dry skin
6%
Bruxism
6%
Mood altered
6%
Cough
6%
Cellulitis
6%
Skin laceration
6%
Contusion
6%
Blood creatine phosphokinase increased
6%
Glycosylated haemoglobin increased
6%
Eye contusion
6%
Ear pruritis
6%
Toothache
6%
Catheter site inflammation
6%
Injection site erythema
6%
Seasonal allergy
6%
Nasal disorder
6%
Pain
6%
Catheter site nodule
6%
Diarrhoea
6%
Musculoskeletal pain
6%
Sinus headache
6%
Somnolence
6%
Restlessness
6%
Nasal dryness
6%
Rhinorrhoea
6%
Sinus congestion
6%
Tachypnoea
6%
Acne
6%
Dermatitis contact
6%
Rash macular
6%
Skin lesion
6%
Drug abuser
6%
Phlebitis
6%
Visual impairment
6%
Feeling of relaxation
6%
Neck pain
6%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IXT-m200, 20 mg/kg: Day 4-126
IXT-m200, 6 mg/kg: Day 4-126
Placebo: Day 4-126
All Subjects: Day 1-3
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IXT-m200Experimental Treatment1 Intervention
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.
Group II: Treatment as Usual (TAU)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IXT-m200
2021
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,716 Total Patients Enrolled
InterveXion Therapeutics, LLCLead Sponsor
4 Previous Clinical Trials
189 Total Patients Enrolled
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
127 Previous Clinical Trials
21,973 Total Patients Enrolled