NCT05006352CompletedPhase 1
A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 7 Aug 2021
- Start date
- 11 Aug 2021
- Primary completion date
- 15 Dec 2022
- Lead sponsor
- Denali Therapeutics Inc.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05006352
- EudraCT number
- 2021-001766-37
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 29
- From 11 Aug 2021 to the primary completion date, 15 Dec 2022
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of malignancy within 5 years
- History of clinically significant neurologic disorders other than ALS
Lab values
- Positive serum pregnancy test or currently lactating or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Human Drug Research (CHDR) Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Atrium Health Neurosciences Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| PPD Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| University of California At San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| HonorHealth Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.