A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
Phase 2 – studying effectiveness and dosage
Conditions:
Parkinson's Disease (PD)
Sponsor: TrueBinding, Inc.
trial.available_in:
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Overview
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).
Who can participate
Inclusion Criteria:
1. 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:
2. Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
3. Less than 5 years from the initial PD diagnosis, at the time of ICF.
4. Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
5. Participants who are on immediate-release levodopa-carbidopa/benserazide.
Other Health Related Criteria
6. No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
7. Free of significant health issues that might interfere with study participation.
Other Criteria/Social Circumstances
8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.
Exclusion Criteria:
Parkinsons's Disease Related Criteria
1. History of sudden, unexpected PD medication OFF episodes.
2. Severe motor complications or disabling symptoms that may impact study involvement.
Other Health Related Criteria
3. Any condition or health concern deemed a safety risk or likely to interfere with study results.
4. Severe psychiatric disorders, including psychosis or substance addiction.
5. Allergies or sensitivities to specific study-related treatments or substances.
6. Any prior history of a severe infusion reaction.
Other Criteria/Social Circumstances
7. Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
8. Recent use of investigational drugs or therapeutic antibodies.
Interventions
TB006
DRUG
Placebo
DRUG
Locations
14
United States (14)
Parkinson's Research Centers of America - Orange County
Aliso Viejo , California
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton , Florida
Parkinson's Research Centers of America - Long Island
Commack , New York
CenExel Rocky Mountain Clinical Research
Englewood , Colorado
Quest Research Institute
Farmington Hills , Michigan
Josephson Wallack Munshower Neurology - Southeast
Indianapolis , Indiana
University of Kansas Medical Center
Kansas City , Kansas
University of Miami
Miami , Florida
Consultants in Neurology, Ltd
Northbrook , Illinois
Parkinson's Research Centers of America - Palo Alto
Palo Alto , California
NYU Langone Health
Patchogue , New York
Oregon Health & Science University
Portland , Oregon
Central Texas Neurology Consultants
Round Rock , Texas
University of South Florida Parkinson's and Movement Disorders Center