A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
1 other identifier
interventional
62
1 country
14
Brief Summary
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2025
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 14, 2025
CompletedStudy Start
First participant enrolled
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 28, 2026
April 23, 2026
April 1, 2026
1.7 years
January 8, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from Baseline in Parkinson's Disease Rating Scale Score
Baseline to 28 weeks
Number of Participants Experiencing Adverse Events
28 weeks
Number of Participants Experiencing Serious Adverse Events
28 weeks
Secondary Outcomes (3)
Change from Baseline in Parkinson's Disease Rating Scale Sub-score
Baseline to 28 weeks
Change from Baseline in Patient Perceived Severity of Disease
Baseline to 28 weeks
Change from Baseline in Clinician Perceived Severity of Disease
Baseline to 28 weeks
Study Arms (2)
TB006
EXPERIMENTALParticipants will receive TB006 via intravenous (IV) infusion.
Placebo
PLACEBO COMPARATORParticipants will receive placebo via IV infusion.
Interventions
Eligibility Criteria
You may qualify if:
- Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.
- Parkinson's Disease Related Criteria:
- Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
- Less than 5 years from the initial PD diagnosis, at the time of ICF.
- Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
- Participants who are on immediate-release levodopa-carbidopa/benserazide.
- Other Health Related Criteria
- No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
- Free of significant health issues that might interfere with study participation.
- Other Criteria/Social Circumstances
- Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.
You may not qualify if:
- Parkinsons's Disease Related Criteria
- History of sudden, unexpected PD medication OFF episodes.
- Severe motor complications or disabling symptoms that may impact study involvement.
- Other Health Related Criteria
- Any condition or health concern deemed a safety risk or likely to interfere with study results.
- Severe psychiatric disorders, including psychosis or substance addiction.
- Allergies or sensitivities to specific study-related treatments or substances.
- Any prior history of a severe infusion reaction.
- Other Criteria/Social Circumstances
- Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
- Recent use of investigational drugs or therapeutic antibodies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, 92656, United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
University of Miami
Miami, Florida, 33136, United States
University of South Florida Parkinson's and Movement Disorders Center
Tampa, Florida, 33613, United States
Consultants in Neurology, Ltd
Northbrook, Illinois, 60062, United States
Josephson Wallack Munshower Neurology - Southeast
Indianapolis, Indiana, 46256, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, 11725, United States
NYU Langone Health
Patchogue, New York, 11772, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 14, 2025
Study Start
March 20, 2025
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
November 28, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share