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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT03318523
• Date of registration: 19/10/2017
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease SPARK
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
• Date of first enrolment: January 10, 2018
• Target sample size: 357
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03318523
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, France, Germany, Israel, Italy, Spain, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: BIIB054

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 and Week 72 [Time Frame: Baseline, Week 52, Week 72]

Secondary Outcome(s)

Change From Baseline in Striatal Binding Ratio (SBR) in Putamen, Striatum, and Caudate [Time Frame: Baseline, Week 52]

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale MDS-UPDRS Total Score (Sum of Parts I, II, and III) at End of Study [Time Frame: Baseline, Week 178]

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale MDS-UPDRS Subparts I, II and III at Week 52, Week 72 and End of Study [Time Frame: Baseline, Week 52, Week 72 and Week 178]

Percentage of Participants With Anti-BIIB054 Antibodies in the Serum [Time Frame: Baseline up to Week 144]

Serum Concentration of BIIB054 [Time Frame: Baseline up to Week 144]

Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) [Time Frame: Up to 178 weeks]

Secondary ID(s)

2016-004610-95

228PD201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors