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Small Molecule

DNL343 for ALS

Phase 2 & 3
Waitlist Available
Led By Merit Cudkowicz, MD
Research Sponsored by Merit E. Cudkowicz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Diagnosis of epilepsy or seizure within 6 months of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial is testing a potential new treatment for ALS to see if it is safe and effective.

Who is the study for?
This trial is for people with ALS, also known as Lou Gehrig's disease. Participants must not have had a seizure in the last 6 months and cannot be taking certain medications that affect liver enzymes or drug transporters.
What is being tested?
The HEALEY ALS Platform Trial - Regimen G is testing DNL343 against a placebo to see if it's safe and effective for treating ALS. Patients will either receive the actual drug or a dummy pill without knowing which one they're getting.
What are the potential side effects?
Potential side effects of DNL343 are not specified here, but may include reactions related to hypersensitivity to its ingredients. As with many trials, there could be risks associated with new drugs that will be monitored throughout the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with epilepsy or had a seizure in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Progression
Secondary study objectives
Combined Assessment of Function and Survival (CAFS)
Function
Muscle Strength
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DNL343Experimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DNL343
2020
Completed Phase 1
~160

Find a Location

Who is running the clinical trial?

Denali Therapeutics Inc.Industry Sponsor
23 Previous Clinical Trials
1,690 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
44 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
2,614 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
2,614 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
2,431 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,431 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

DNL343 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05842941 — Phase 2 & 3
Amyotrophic Lateral Sclerosis Research Study Groups: DNL343, Matching Placebo
Amyotrophic Lateral Sclerosis Clinical Trial 2023: DNL343 Highlights & Side Effects. Trial Name: NCT05842941 — Phase 2 & 3
DNL343 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842941 — Phase 2 & 3
~67 spots leftby Jul 2025
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