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Small Molecule

DNL343 for Amyotrophic Lateral Sclerosis

Atrium Health Neurosciences Institute, Charlotte, NC

DNL343 +1 morePhase 1Waitlist AvailableResearch Sponsored by Denali Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sporadic or familial ALS

≤ 4 years since ALS symptom onset

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up19 months

Awards & highlights

Study Summary

This trial is testing a new drug for safety, how it is processed by the body, and how it affects people with ALS.

Eligible Conditions

ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have been diagnosed with sporadic or familial ALS.

Select...

You have had symptoms of ALS for less than 4 years.

Select...

Your lung function is better than half of what is expected for someone of your age, height, and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of treatment-emergent adverse events (TEAEs) throughout the double-blind period

Secondary outcome measures

Cerebrospinal fluid-to-plasma concentration ratio of DNL343 following multiple oral doses

PK parameter: Area under the concentration-time curve from time zero to 24 hours (AUC24) of DNL343 in plasma

PK parameter: Maximum concentration (Cmax) of DNL343 in plasma

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: DNL343 (Low Dose)Experimental Treatment1 Intervention

Group II: DNL343 (High Dose)Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DNL343

2020

Completed Phase 1

~130

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Denali Therapeutics Inc.Lead Sponsor

20 Previous Clinical Trials

1,821 Total Patients Enrolled

2 Trials studying Amyotrophic Lateral Sclerosis

255 Patients Enrolled for Amyotrophic Lateral Sclerosis

Richard Tsai, MDStudy DirectorDenali Therapeutics Inc.

2 Previous Clinical Trials

127 Total Patients Enrolled

Linus Sun, MD, PhDStudy DirectorDenali Therapeutics Inc.

Media Library

DNL343 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05006352 — Phase 1

Amyotrophic Lateral Sclerosis Research Study Groups: DNL343 (Low Dose), DNL343 (High Dose), Placebo

Amyotrophic Lateral Sclerosis Clinical Trial 2023: DNL343 Highlights & Side Effects. Trial Name: NCT05006352 — Phase 1

DNL343 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006352 — Phase 1

Frequently Asked Questions

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

How many healthcare centers are administering this research protocol?

"This medical trial is being conducted out of several geographic locations including the California Pacific Medical Center in San Francisco, CA; HonorHealth in Scottsdale, AZ.; and the University of California at San Diego in San Diego, FL., with an additional 5 sites."

Answered by AI

Does this research venture accept volunteers aged sixty and over?

"The age range for this trial is between 18 and 80. Patients younger than the minimum age requirement can look into 44 additional studies, while those above 65 years old have 394 options to consider."

Answered by AI

What cohorts of people are eligible to participate in this research?

"This study is hoping to find 30 ameliorative candidates aged between 18 and 80 who are suffering from amyotrophic lateral sclerosis. The following further requirements must be met: Participants must be able to ingest the medication, female participants have either undergone sterilization or entered menopause, while male subjects in conjunction with their partners of reproductive age need to use reliable contraception methods."

Answered by AI

What risks are posed by the use of DNL343 for patient treatments?

"As the initial phase of clinical testing, there is limited evidence regarding DNL343's safety and efficacy. Therefore, we have rated it a 1 on our scale."

Answered by AI

Is it currently possible for individuals to enrol in this experiment?

"This research endeavor, which was initially published on August 11th 2021, is actively searching for participants according to clinicaltrials.gov's records and the latest update occurred on June 6th 2022."

Answered by AI

How many participants can join the study at its peak?

"Affirmative. The information on clinicaltrials.gov confirms that this medical study, which was initially posted in August 11th 2021, is actively recruiting participants across 5 sites for a total of 30 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

2021. "A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006352.

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