A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease

Launched by TRUEBINDING, INC. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial, called the TB006 study, is looking at a new treatment for people with Parkinson's Disease (PD) to see if it can help improve motor function, which includes movement and coordination. The researchers want to find out how well TB006 works and how safe it is for participants. The trial is currently recruiting individuals aged 18 to 80 who have been diagnosed with early-stage Parkinson's Disease and have experienced some improvement in their symptoms with a common medication called levodopa.

To participate, individuals need to agree to join the study and sign a consent form. They should have had Parkinson’s for less than five years and have mild symptoms. Participants must be free from serious health issues and certain conditions that could affect their safety or the study results. Throughout the trial, participants will receive regular check-ups to monitor their health. If you or someone you know is interested, it's important to discuss with a healthcare provider to see if this trial might be a good fit.

Gender

ALL

Eligibility 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.