Status:
TERMINATED
Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
Lead Sponsor:
Biogen
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scal...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening.
- Score of ≤2.5 on the Modified Hoehn and Yahr Scale.
- Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study's Medical Monitor on a case by case basis.
- Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading).
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment.
- Exclusion Criteria:
- Presence of freezing of gait.
- Montreal cognitive assessment (MOCA) score \<23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation.
- History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader.
- History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study.
- Participation in any active immunotherapy study targeting alpha-synuclein.
- Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study.
- Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator.
- Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).
- NOTE : Other protocol defined Inclusion/Exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT03318523
Start Date
January 10 2018
End Date
April 29 2021
Last Update
February 28 2022
Active Locations (75)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
Research Site
La Jolla, California, United States, 92093-0886
4
Cedars Sinai
Los Angeles, California, United States, 90048