BIIB094
DrugAdministered as specified in the treatment arm.
NCT Number: NCT03976349
The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.
Looking for future studies?
Notify Me35 year–80 year
All sexes
Interventional
Phase 1
Research Site, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Time frame: Part A: Screening (Day -42) up to Day 85, Part B: Screening (Day -77) up to Day 253
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Time frame: Part A: pre-dose through Day 57, Part B: pre-dose through Day 169
Ionis Pharmaceuticals, Inc.
Industry
A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's Disease
Acronym: REASON
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03648905
Autonomic Failure, Autonomic Nervous System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01621581
Basal Ganglia Diseases, Brain Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05699460
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Irvine, California, United States
View Trial DetailsNCT07720869
Basal Ganglia Diseases, Brain Diseases
Baton Rouge, Louisiana, United States
View Trial Details