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Small Molecule
DNL343 for Amyotrophic Lateral Sclerosis
Phase 1
Waitlist Available
Research Sponsored by Denali Therapeutics Inc.
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 19 months
Awards & highlights
Summary
This trial tests a new drug called DNL343 in people with ALS. It aims to see if the drug is safe and how it affects the disease. Researchers will study how the drug moves through the body and its impact on ALS symptoms.
Eligible Conditions
- ALS (Amyotrophic Lateral Sclerosis)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Denali Therapeutics Inc.Lead Sponsor
22 Previous Clinical Trials
1,839 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function is good, and you can breathe well.You have a history of serious health problems that are not well managed or under control.You have been diagnosed with cancer in the past 5 years.You have a history of important brain or nerve disorders besides ALS.You have been diagnosed with sporadic or familial ALS.You have had symptoms of ALS for 4 years or less.
Research Study Groups:
This trial has the following groups:- Group 1: DNL343 (Low Dose)
- Group 2: DNL343 (High Dose)
- Group 3: Placebo
Awards:
This trial has 0 awards, including: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.
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