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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Progression

Secondary outcome measures

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

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Denali Therapeutics Inc.Industry Sponsor

22 Previous Clinical Trials

1,629 Total Patients Enrolled

2 Trials studying Amyotrophic Lateral Sclerosis

45 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being included in the recruitment of this trial?

"This medical study caters to adults between 18-100. Patients younger than 18 are invited to join 7 other trials, and 120 studies exist for those over 65 years old."

Answered by AI

Am I eligible to partake in this research program?

"Eligible candidates for this medical trial must suffer from amyotrophic lateral sclerosis and be within the ages of 18 to 100. A total of 240 individuals will join the experiment as participants."

Answered by AI

Is this research endeavor still open to participants?

"As disclosed by clinicaltrials.gov, this trial is no longer recruiting candidates as the last update was on May 29th 2023. The initial posting of this study took place on May 24th 2023. There are currently 122 other medical studies actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEALEY ALS Platform Trial - Regimen G DNL343

Merit E. Cudkowicz, MD 2023. "HEALEY ALS Platform Trial - Regimen G DNL343". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05842941.

All > Lou Gehrigs Disease > Als