Study Purpose:
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)Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
DNL343, Placebo
Placebo:
Yes
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Linus Sun, MD, PhD, Denali Therapeutics Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Centre for Human Drug Research (CHDR)
Leiden, South Holland, Netherlands
Full Study Summary:
Study Sponsor:
Denali Therapeutics Inc.
Estimated Enrollment:
30
Estimated Study Start Date:
08 / 11 / 2021
Estimated Study Completion Date:
12 / 01 / 2023
Posting Last Modified Date:
06 / 08 / 2022
Date Study Added to neals.org:
08 / 16 / 2021
Minimum Age:
18 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
Key Inclusion Criteria:- Diagnosis of sporadic or familial ALS
- Less than 3 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 or be postmenopausal
- Men, and sex partner if a woman of childbearing potential, must use highly effective contraception
Key Exclusion Criteria:
- 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
HonorHealth | Recruiting
Rebecca Otutoa / 602-840-4868 / mailto:rotutoa@honorhealth.com
Scottsdale, Arizona
85251
United States
University of California at San Diego | Recruiting
Rose Previte / 858-246-1319 / email hidden; JavaScript is required
San Diego, California
92093
United States
California Pacific Medical Center | Recruiting
Marnina Murez / 638-224-7736 / email hidden; JavaScript is required
San Francisco, California
94115
United States
PPD Orlando | Recruiting
Project Manager / 689-216-3179 / email hidden; JavaScript is required
Orlando, Florida
32806
United States
Emory University | Recruiting
Clinical Research Nurse / 404-727-1679 / email hidden; JavaScript is required
Atlanta, Georgia
30322
United States
Centre for Human Drug Research (CHDR) | Recruiting
Project Manager / +31 71 5246 400 / email hidden; JavaScript is required
Leiden, South Holland
2333
Netherlands