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Virus Therapy

XT-150 for ALS

Phase 1

Waitlist Available

Research Sponsored by Xalud Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults between 18 and 80 years of age

Have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS. Patients currently receiving Tofersen are not eligible

Must not have

Taking any prohibited medications

Women who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 180

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new drug called XT-150 on adult patients with Amyotrophic Lateral Sclerosis (ALS). Participants will receive a single injection of XT-150 and will be monitored for

Who is the study for?

This trial is for adults with Amyotrophic Lateral Sclerosis (ALS), a type of motor neuron disease. Participants must provide informed consent and meet all study requirements to receive a single injection of XT-150 and be followed up for 6 months.

What is being tested?

The safety of XT-150, given as a single injection, is being tested in ALS patients. This Phase 1 trial will have two groups receiving different doses: one group gets 1.5 mg and another gets 4.5 mg, with each group having four participants.

What are the potential side effects?

As this is an early-phase safety study, the specific side effects are not listed but may include reactions at the injection site or other unexpected symptoms related to drug tolerance which will be monitored over six months.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have not been treated for ALS or am on a stable dose of an approved ALS treatment, excluding Tofersen.

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I can follow the study plan and expect to live 6 months or more.

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I have been diagnosed with ALS by a doctor.

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I can exhale at least 60% of the expected air volume for my age, sex, and height.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that are not allowed in the study.

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I am not pregnant or nursing.

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I have a tracheostomy.

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I have a history or current diagnosis of cancer, meningitis, HIV, Hepatitis B or C, or uncontrolled diabetes.

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I have an autoimmune disease like rheumatoid arthritis or lupus that needs treatment.

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I do not have heart conditions or ECG abnormalities that pose a significant risk.

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I have or had COPD.

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I have signs of liver or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with clinically significant laboratory abnormalities

Number of participants with clinically significant vital sign abnormalities

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

Group I: Cohort 2: 4.5 mg XT-150Experimental Treatment1 Intervention

Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor.

Group II: Cohort 1: 1.5 mg XT-150Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XT-150

2020

Completed Phase 2

~440

0 / 13Eligibility criteria met