This study is in progress, not accepting new patients

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

a study on Amyotropic Lateral Sclerosis (ALS)

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)

Official Title

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, Followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Details

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Keywords

Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, Sclerosis, DNL343

Eligibility

You can join if…

Open to people ages 18-80

  • Diagnosis of sporadic or familial ALS
  • ≤ 4 years since ALS symptom onset
  • Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening
  • Participants must be able to swallow the study intervention
  • Vital capacity >50% predicted at screening
  • Women must have been surgically sterilized, be postmenopausal, or for participants of childbearing potential, must not be pregnant, and both the participant and the male partner must use highly effective contraception
  • Men, and sex partner if a woman of childbearing potential, must use highly effective contraception

You CAN'T join if...

  • Any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
  • Positive serum pregnancy test or currently lactating or breastfeeding
  • History of malignancy within 5 years
  • History of clinically significant neurologic disorders other than ALS

Locations

  • University of California at San Diego
    San Diego California 92093 United States
  • California Pacific Medical Center
    San Francisco California 94115 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Denali Therapeutics Inc.
ID
NCT05006352
Phase
Phase 1 Amyotropic Lateral Sclerosis (ALS) Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated