IXT-m200 for Methamphetamine Dependence

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Methamphetamine Dependence+1 More
IXT-m200 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new drug, IXT-m200, to see if it is safe and effective in treating people with methamphetamine use disorder. The hypothesis is that IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder.

Eligible Conditions
  • Methamphetamine Dependence
  • methamphetamine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Methamphetamine Dependence

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 33 weeks

20 weeks
Percent of 20 weeks abstinent from stimulants following a 4-week grace period
25 weeks
Complete abstinence during last month of study drug treatment
Number of sequential weeks of abstinence from the end of treatment
Proportion of responders in early remission at Week 25 as measured by DSM-5 criteria
Proportion of responders with reduced DSM-5 criteria at Week 25 as measured by DSM-5 criteria
Weekly abstinence from stimulants following a 4-week grace period
33 weeks
Change from screening in participant-rated quality of life as measured by the Treatment Effectiveness Assessment
Change from screening in the Treatment Effectiveness Assessment
Difference between groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33
Difference between groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33
Number of participants with anti-IXT-m200 antibody levels that are confirmed positive and have titers more than three times the minimum required dilution
Number of treatment-related AEs as measured by ECG
Number of treatment-related AEs as measured by clinical laboratory testing
Number of treatment-related AEs as measured by immune response
Number of treatment-related AEs as measured by vital signs
Number of treatment-related adverse events (AEs) as measured by physical examination
Point prevalence abstinence (last 7 days)
Proportion of responders in early remission at Week 33 as measured by DSM-5 criteria
Proportion of responders with reduced DSM-5 criteria at Week 33 as measured by DSM-5 criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Methamphetamine Dependence

Side Effects for

All Subjects: Day 1-3
48%Euphoric mood
26%Hypervigilance
19%Feeling hot
18%Palpitations
13%Injection site pain
12%Hyperhidrosis
12%Headache
10%Dry mouth
9%Dizziness
9%Tachycardia
8%Energy increased
8%Bruxism
6%Paraesthesia
5%Fatigue
5%Feeling abnormal
5%Nausea
5%Restlessness
4%Abdominal discomfort
4%Catheter site pain
4%Logorrhoea
4%Hot flush
3%Disgeusia
3%Vomiting
3%Decreased appetite
3%Disturbance in sexual arousal
3%Anxiety
1%Migraine with aura
1%Change in sustained attention
1%Hepatic enzyme increased
1%Restless legs syndrome
1%Dysarthria
1%Hyperaesthesia
1%Eye irritation
1%Skin laceration
1%Visual impairment
1%Abdominal pain
1%Chest discomfort
1%Heart rate increased
1%Tremor
1%Insomnia
1%Oropharyngeal pain
1%Cough
1%Dermatitis contact
1%Hypertension
1%Ear pain
1%Discomfort
1%Thirst
1%Electrocardiogram ST segment depression
1%Electrocardiogram ST-T change
1%Sputum increased
1%Flushing
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT03336866) in the All Subjects: Day 1-3 ARM group. Side effects include: Euphoric mood with 48%, Hypervigilance with 26%, Feeling hot with 19%, Palpitations with 18%, Injection site pain with 13%.

Trial Design

2 Treatment Groups

IXT-m200
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: IXT-m200 · Has Placebo Group · Phase 2

IXT-m200
Drug
Experimental Group · 1 Intervention: IXT-m200 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volociximab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 33 weeks

Who is running the clinical trial?

InterveXion Therapeutics, LLCLead Sponsor
4 Previous Clinical Trials
168 Total Patients Enrolled
1 Trials studying Methamphetamine Dependence
77 Patients Enrolled for Methamphetamine Dependence
National Institute on Drug Abuse (NIDA)NIH
2,225 Previous Clinical Trials
5,612,807 Total Patients Enrolled
30 Trials studying Methamphetamine Dependence
1,922 Patients Enrolled for Methamphetamine Dependence
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
110 Previous Clinical Trials
19,739 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Colorado27.3%
Texas18.2%
New Mexico9.1%
Other45.5%
How old are they?
18 - 65100.0%
What site did they apply to?
Altea Research Institute30.0%
Pahl Pharmaceutical Professionals20.0%
Pillar Clinical Research20.0%
Other30.0%
What portion of applicants met pre-screening criteria?
Met criteria90.9%
Did not meet criteria9.1%
How many prior treatments have patients received?
2100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email100.0%
Most responsive sites:
  1. Altea Research Institute: < 24 hours