Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 80
Updated:3/23/2019
Start Date:January 10, 2018
End Date:April 6, 2022
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease

To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of
BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the
pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.


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.

- 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
We found this trial at
38
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Natividad Stover
Phone: 205-996-2807
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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12605 East 16th Avenue
Aurora, Colorado 80045
Principal Investigator: Maureen Leehey
Phone: 303-724-4644
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Phone: 617-638-7745
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, Illinois
Principal Investigator: Tatyana Simuni
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Anwar Ahmed
Phone: 216-444-1134
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Englewood, Colorado 80113
Principal Investigator: Rajeev Kumar
Phone: 303-762-6674
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Farmington Hills, Michigan 48334
Principal Investigator: Aaron L Ellenbogen, DO, MPH
Phone: 248-957-8940
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Houston, TX
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Innsbruck,
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Jacksonville, Florida 32224
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Kansas City, Kansas
Principal Investigator: Rajesh Pahwa
Phone: 913-588-6989
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Los Angeles, California 90048
Principal Investigator: Michele Tagliati
Phone: 424-315-2466
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-9307
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New Orleans, Louisiana 70121
Phone: 504-703-0755
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445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Harini Sarva
Phone: 212-746-1685
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, New York 10017
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100 West Gore Street
Orlando, Florida 32806
Principal Investigator: Ira Goodman
Phone: 407-426-9299
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Phoenix, Arizona 85013
Principal Investigator: Holly A Shill, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Lana Chahine
Phone: 412-692-4302
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
Principal Investigator: Jill Ostrem
Phone: 415-502-2956
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Spokane, Washington 99202
Principal Investigator: Jason Aldred
Phone: 509-714-5122
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Sun City, Arizona 85351
Principal Investigator: David R Shprecher, DO
Phone: 623-832-6512
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Tampa, Florida
Principal Investigator: Robert Hauser
Phone: 813-396-0756
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Williamsville, New York 14221
Principal Investigator: Thomas Guttuso
Phone: 716-832-6080
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Winston-Salem, North Carolina 27157
Phone: 336-716-8694
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