NL-OMON23923
Completed
N/A
•A Randomized, Placebo-Controlled, Double-Blind, Parallel Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of LTI-291 in Patients with Parkinson’s Disease and a GBA1 Mutation
•Lysosomal Therapeutics, Incorporated0 sites40 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- PD patients with a GBA1 mutation , movement disorder
- Sponsor
- •Lysosomal Therapeutics, Incorporated
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed informed consent prior to any study\-mandated procedure.
- •2\.Minimum age of 18 years.
Exclusion Criteria
- •1\.Any active or chronic disease or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following medical history review, physical examination, vital signs (supine systolic and diastolic blood pressure, pulse rate, body temperature), 12\-lead electrocardiogram (ECG), and clinical laboratory parameters (hematology, blood chemistry, and urinalysis)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance.
- •2\.History of recent major surgery (within 60 days of screening) that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator.
Outcomes
Primary Outcomes
Not specified
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