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
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Natividad Stover
Phone: 205-996-2807
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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12605 East 16th Avenue
Aurora, Colorado 80045
Principal Investigator: Maureen Leehey
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1 Boston Medical Center Place
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617.638.8000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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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
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Farmington Hills, Michigan 48334
Principal Investigator: Aaron L Ellenbogen, DO, MPH
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Los Angeles, California 90048
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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445 E 69th St
New York, New York 10021
(212) 746-1067
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100 West Gore Street
Orlando, Florida 32806
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Pittsburgh, Pennsylvania 15213
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
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Tampa, Florida
Principal Investigator: Robert Hauser
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Williamsville, New York 14221
Principal Investigator: Thomas Guttuso
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Winston-Salem, North Carolina 27157
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