A Study Evaluating the Safety and Tolerability of QRL-201 in ALS
NCT ID: NCT05633459
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
64 participants
INTERVENTIONAL
2022-12-16
2026-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QRL-201: Sporadic ALS
Multiple-ascending doses of QRL-201 will be intrathecally administered to individuals with ALS.
Multiple ascending doses of QRL-201
Multiple ascending doses of QRL-201 will be intrathecally administered to individuals with sporadic ALS.
Placebo: Sporadic ALS
Multiple-ascending doses of placebo comparator will be intrathecally administered to individuals with ALS.
Multiple ascending doses of Placebo
Multiple ascending doses of placebo comparator will be intrathecally administered to individuals with sporadic ALS.
QRL-201: C9orf72-ALS
QRL-201 will be intrathecally administered to individuals with C9orf72-ALS.
QRL-201
QRL-201 will be intrathecally administered to individuals with C9orf72 ALS.
Placebo: C9orf72-ALS
Placebo comparator will be intrathecally administered to individuals with C9orf72-ALS.
Placebo
Placebo comparator will be intrathecally administered to individuals with C9orf72 ALS.
Interventions
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Multiple ascending doses of QRL-201
Multiple ascending doses of QRL-201 will be intrathecally administered to individuals with sporadic ALS.
Multiple ascending doses of Placebo
Multiple ascending doses of placebo comparator will be intrathecally administered to individuals with sporadic ALS.
QRL-201
QRL-201 will be intrathecally administered to individuals with C9orf72 ALS.
Placebo
Placebo comparator will be intrathecally administered to individuals with C9orf72 ALS.
Eligibility Criteria
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Inclusion Criteria
* ALS symptom onset within 24 months of Screening
* Slow vital capacity \>50%
* Clinical or electrodiagnostic evidence of lower motor neuron involvement
* Not pregnant and not nursing
* Willing and able to practice effective contraception
* Able to tolerate lumbar puncture
* If on approved therapies for the treatment of ALS during the course of the study, must be on a stable dose (at the Sponsor's discretion)
Exclusion Criteria
* Currently enrolled in any other clinical study involving either an investigational product (IP) or off-label use of a drug or device
* Prior exposure to stem cell or gene therapy products
* Any contraindication to intrathecal drug administration
* Abnormal laboratory values deemed clinically significant by the Investigator
* Significant infection or known inflammatory process
* Any sign and/or history of neurological conditions and other neuromuscular disorders that could affect the electrophysiological recordings.
* An EEG that shows signs of abnormal electrical activity (e.g., epilepsy)
18 Years
80 Years
ALL
No
Sponsors
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QurAlis Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Angela Genge, MD
Role: STUDY_DIRECTOR
QurAlis Corporation
Locations
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Universitaire Ziekenhuizen Leuven (UZ Leuven)
Leuven, , Belgium
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
Montreal Neurological Institute-Hospital
Montreal, Quebec, Canada
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)
Bonn, North Rhine-Westphalia, Germany
Charité Research Organisation
Berlin, , Germany
University Hospital Schleswig-Holstein (UKSH) Campus Lübeck, Department for Neurology/ Precision Neurology
Lübeck, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
St James's Hospital
Dublin, , Ireland
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
The University of Sheffield, Royal Hallamshire Hospital
Sheffield, United Kingdom, United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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Other Identifiers
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QRL-201-01
Identifier Type: -
Identifier Source: org_study_id
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