Testing TB006 for improving motor function in 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
PHASE2 · TrueBinding, Inc. · NCT06773962
This study is testing if a new treatment called TB006 can help improve movement in people with early-stage Parkinson's Disease who are already feeling better with their current medication.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | TrueBinding, Inc. (industry) |
| Locations | 6 sites (Aliso Viejo, California and 5 other locations) |
| Trial ID | NCT06773962 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of TB006, a monoclonal antibody, in participants diagnosed with Parkinson's Disease (PD). The study aims to determine if TB006 can enhance motor function in early-stage PD patients who have shown improvement with levodopa treatment. Participants will be randomly assigned to receive either TB006 or a placebo, and their progress will be monitored throughout the trial. The study is designed to gather data on both the therapeutic effects and safety profile of TB006.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with early-stage Parkinson's Disease who have mild symptoms and are currently on levodopa treatment.
Not a fit: Patients with advanced Parkinson's Disease or those with significant health issues that could interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor function and quality of life for patients with Parkinson's Disease.
How similar studies have performed: While there have been studies on monoclonal antibodies for various conditions, this specific approach for Parkinson's Disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aliso Viejo, California and 5 other locations
- Parkinson's Research Centers of America - Orange County — Aliso Viejo, California, United States (RECRUITING)
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (RECRUITING)
- Josephson Wallack Munshower Neurology - Southeast — Indianapolis, Indiana, United States (RECRUITING)
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
- Quest Research Institute — Farmington Hills, Michigan, United States (RECRUITING)
- Central Texas Neurology Consultants — Round Rock, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: TrueBinding, Inc.
- Email: clinicaltrial@truebinding.com
- Phone: 650-847-1117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, PD, TB006, Monoclonal Antibody