Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200

Phase 2

Terminated

• Conditions: Methamphetamine-dependence; Methamphetamine Abuse
• Interventions: Drug: IXT-m200; Other: Placebo

• Registration Number: NCT05034874
• Lead Sponsor: InterveXion Therapeutics, LLC

Brief Summary

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Study Start: 2022-06-09
• Primary Completion: 2023-09-11
• Study Completion: 2023-11-07
• Status Verified: 2024-05
• Results First Submitted: 2024-08-30
• Results First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Results First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IXT-m200	IXT-m200	Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g
Placebo	Placebo	Saline

Primary Outcome Measures

Name	Time	Method
Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period	20 weeks	The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.

Secondary Outcome Measures

Name	Time	Method
Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.	Weeks 13, 25, and 33	Treatment Effectiveness Assessment (TEA) asks questions in four domains with results ranging from 4-40 with higher scores representing a better outcome.
Proportion of Responders in Early Remission at Week 25 as Measured by DSM-5 Criteria	25 weeks	A responder is defined as a participant who meets the definition of early remission, i.e., at least 3 months and \<12 months without meeting DSM-5 criteria other than craving.
Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33	Weeks 13, 25, and 33	The CGIC asks clinicians to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.
Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33	Weeks 13, 25, and 33	The PGIC asks patients to complete one statement with the result ranging from 1-7 with lower scores representing a better outcome.

Trial Locations

Locations (7)

Alpine Research; 🇺🇸 Clinton, Utah, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Woodlands International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Pillar Clinical Research; 🇺🇸 Richardson, Texas, United States

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

HD Research; 🇺🇸 Houston, Texas, United States