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QRL-201 for ALS

Phase 1
Recruiting
Research Sponsored by QurAlis Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to tolerate lumbar puncture
Clinical evidence of lower motor neuron involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 253 days
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective in treating ALS.

Who is the study for?
This trial is for adults aged 18-80 with ALS, who have had symptoms start within the last 2 years. They must be able to perform a breathing test and not be on varying doses of ALS therapies. Participants should not be pregnant or nursing, can undergo spinal taps, and must use contraception.Check my eligibility
What is being tested?
The study tests the safety of different doses of QRL-201 in people with ALS. It involves multiple levels of dosing to find out which is safest and most tolerable for patients.See study design
What are the potential side effects?
While specific side effects are not listed, they may include reactions related to various dosages of QRL-201 or procedures like lumbar puncture. Safety and tolerability are key focuses, so monitoring for any adverse effects will be part of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can undergo a lumbar puncture procedure.
Select...
My condition shows signs of nerve damage affecting muscle movement.
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I am between 18 and 80 years old and have been diagnosed with ALS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 253 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 253 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with one or more treatment emergent adverse events and serious adverse events
Secondary outcome measures
Pharmacokinetics (plasma): Area under the concentration time curve from zero to infinity (AUCinf) of QRL-201
Pharmacokinetics (plasma): Maximum observed concentration of QRL-201 (Cmax)
Pharmacokinetics (plasma): Time of maximum concentration (Tmax) of QRL-201

Trial Design

8Treatment groups
Experimental Treatment
Group I: QRL-201 - Arm 8Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group II: QRL-201 - Arm 7Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group III: QRL-201 - Arm 6Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group IV: QRL-201 - Arm 5Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group V: QRL-201 - Arm 4Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group VI: QRL-201 - Arm 3Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group VII: QRL-201 - Arm 2Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201
Group VIII: QRL-201 - Arm 1Experimental Treatment1 Intervention
Placebo Comparator: Placebo consists of the same components as the formulation buffer for QRL-201

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol. Riluzole works by inhibiting glutamate release, which is thought to reduce excitotoxicity that leads to motor neuron death. Edaravone acts as an antioxidant, reducing oxidative stress and slowing functional decline. Sodium phenylbutyrate-taurursodiol combines two compounds that reduce neuronal cell death by targeting cellular stress pathways. These treatments are crucial for ALS patients as they aim to slow disease progression, preserve motor function, and improve quality of life.
Translating biological findings into new treatment strategies for amyotrophic lateral sclerosis (ALS).

Find a Location

Who is running the clinical trial?

QurAlis CorporationLead Sponsor
1 Previous Clinical Trials
88 Total Patients Enrolled
Angela Genge, MDStudy DirectorQurAlis Corporation

Media Library

QRL-201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05633459 — Phase 1
Amyotrophic Lateral Sclerosis Research Study Groups: QRL-201 - Arm 6, QRL-201 - Arm 5, QRL-201 - Arm 4, QRL-201 - Arm 8, QRL-201 - Arm 7, QRL-201 - Arm 1, QRL-201 - Arm 2, QRL-201 - Arm 3
Amyotrophic Lateral Sclerosis Clinical Trial 2023: QRL-201 Highlights & Side Effects. Trial Name: NCT05633459 — Phase 1
QRL-201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633459 — Phase 1
~23 spots leftby May 2025