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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 belowSelect...
I can undergo a lumbar puncture procedure.
Select...
My condition shows signs of nerve damage affecting muscle movement.
Select...
I am between 18 and 80 years old and have been diagnosed with ALS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 253 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 253 days
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition shows signs of nerve damage affecting muscle movement.I have previously received stem cell or gene therapy.I can undergo a lumbar puncture procedure.Your lab test results show a significant health problem, as determined by the doctor in charge of the study.I have a genetic variant in the SOD1 or FUS genes.My ALS symptoms started less than 2 years ago.Your breathing ability is better than 50%.I am on a stable dose of ALS medication as approved by the study sponsor.I have a significant infection or an ongoing inflammatory condition.I cannot receive medications directly into my spinal canal.I am between 18 and 80 years old and have been diagnosed with ALS.
Research Study Groups:
This trial has the following groups:- Group 1: QRL-201 - Arm 6
- Group 2: QRL-201 - Arm 5
- Group 3: QRL-201 - Arm 4
- Group 4: QRL-201 - Arm 8
- Group 5: QRL-201 - Arm 7
- Group 6: QRL-201 - Arm 1
- Group 7: QRL-201 - Arm 2
- Group 8: QRL-201 - Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety measures have been taken into account for QRL-201 - Arm 1?
"Due to the limited amount of clinical data available, our team evaluated QRL-201 - Arm 1 as having a safety score of 1. This is in line with its classification as a Phase 1 trial."
Answered by AI
Is it possible for me to participate in this research endeavor?
"Those hoping to partake in this medical trial must fulfill two prerequisites: they must have als (amyotrophic lateral sclerosis) and be within the age range of 18-80 years. The total amount of individuals accepted into this study is 64."
Answered by AI
Does this research stipulate an age criterion for participants?
"According to the eligibility criteria for this trial, potential participants must be between 18-80 years old; there are 45 trials specifically designed for minors and 373 studies geared towards those above 65."
Answered by AI
How many participants are being observed in this research initiative?
"Affirmative. Clinicaltrials.gov's records declare that this medical investigation, which was originally posted on December 16th 2022, is still recruiting patients. Around 64 individuals need to be enlisted from a single medical center."
Answered by AI
Are there any vacancies for this research trial at present?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial, first posted on December 16th 2022, is currently recruiting participants. 64 individuals must be recruited from one medical centre for the study to proceed as planned."
Answered by AI
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