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 | 
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.
			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
	
									1720 2nd Ave S
Birmingham, Alabama 35233
	
			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
	
			
					Aurora, Colorado 80045
Principal Investigator: Maureen Leehey
			
						
										Phone: 303-724-4644
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									1 Boston Medical Center Place
Boston, Massachusetts 02118
	
			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
	
			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
	
			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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								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
	
			Milwaukee, Wisconsin
(414) 955-8296 
							 
					Phone: 414-805-9307
					
		Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...  
  
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									445 E 69th St
New York, New York 10021
	
			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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									100 West Gore Street
Orlando, Florida 32806
	
			
					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
	
			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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								Williamsville, New York 14221			
	
			
					Principal Investigator: Thomas Guttuso
			
						
										Phone: 716-832-6080
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