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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521431-37-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called ALN-SNCA (called "study drug"). The study is focused on people with early Parkinson's disease, a disorder of the nervous system that affects movement. Parkinson's disease is caused by a gradual loss of nerve cells in the brain, especially those due to the harmful build-up of a protein called α-synuclein.
The aim of the study is to see if the study drug is safe and tolerated well enough to continue testing it in future studies and what side effects may happen from taking the study drug.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-SNCA Dose Escalation | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-SNCA | Drug | Administered per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through Week 80 | |
| Severity of TEAEs | Through Week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of alpha (a)-synuclein protein in CSF | Through Week 48 | |
| Change from baseline in concentration of a-synuclein protein in CSF | Through Week 48 | |
| Concentration of ALN-SNCA in plasma |
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Key Inclusion Criteria:
Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) criteria, as assessed by the investigator, with bradykinesia plus at least one of the other cardinal signs of Parkinson's disease (resting tremor, rigidity), without any other known or suspected cause of Parkinsonism
A diagnosis of Parkinson's disease for 4 years or less at the screening visit
Participant must meet one of the following criteria:
BMI ≤35 kg/m^2 at time of screening visit
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Neurological Institute and Hospital | Recruiting | Montreal | Quebec | H3A 2B4 | Canada | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D009127 | Muscle Rigidity |
| D060825 | Cognitive Dysfunction |
| D019964 | Mood Disorders |
| D020447 | Parasomnias |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Drug |
Administered per the protocol |
|
| Through Week 48 |
| Concentration of major metabolites in plasma | Through Week 48 |
| Concentration of ALN-SNCA in CSF | Through Week 48 |
| Concentration of major metabolites in CSF | Through Week 48 |
| Fraction [fc] of ALN-SNCA excreted in urine | Over 24 hours |
| Fc of major metabolites excreted in urine | Over 24 hours |
| Center for Human Drug Research |
| Recruiting |
| Leiden |
| South Holland |
| 2333 CL |
| Netherlands |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
| D001342 | Autonomic Nervous System Diseases |