DNL151 in Subjects with Parkinson’s Disease
Research type
Research Study
Full title
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects with Parkinson's Disease
IRAS ID
_265193
Contact name
Aliya Asher
Contact email
Sponsor organisation
Denali Therapeutics, Inc.
Eudract number
2019-001297-28
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
Parkinson’s disease is the second most common neurodegenerative (the progressive loss of structure or function of neurons) disease, affecting about 1–2% of individuals aged 65 or over. Standard medications to treat Parkinson’s disease will usually include dopamine replacement therapy (such as levodopa or Sinemet).
The purpose of this clinical research study is to investigate whether DNL151 (the study drug) is safe and tolerable in Parkinson’s disease patients and to investigate how DNL151 is absorbed, broken down, and eliminated from the body. The effect of this drug on the clinical symptoms of Parkinson’s disease is unknown.
Approximately 16 - 20 participants will receive either DNL151 or placebo in this study at study sites (hospitals, clinics and research centres) in the UK. Participants will be required to visit the study site 8 times, not including the Screening Period.
The full duration of the study, including the Follow-up Period, is approximately 10 weeks for each participant. The total duration of the study across all participants is estimated to be approximately 8 months.
The study will randomly assign participants into 3 groups: 2 groups will be given the study drug, DNL151, at two different dose levels. One treatment group will receive a low dose of DNL151 once daily and the other treatment group will receive a high dose of DNL151 once daily. The third group (“control” group) will be given placebo. A placebo is a capsule that looks like a drug, but with no DNL151 in it (also called a “dummy” drug).
The study is organised and funded by Denali Therapeutics Inc. (also known as the “Sponsor” of this study).REC name
North East - York Research Ethics Committee
REC reference
19/NE/0203
Date of REC Opinion
17 Jun 2019
REC opinion
Unfavourable Opinion