A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Parkinson's Disease (PD)
In brief
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).
Key facts
- Study ID
- NCT06773962
- Run by
- TrueBinding, Inc.
- People needed
- 62
- Starts
- 2025-03-20
- Expected to finish
- 2026-11-28
- Last updated by the study team
- 2026-04-23
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Parkinson's Research Centers of America - Orange County — Aliso Viejo, California, United States
- Parkinson's Research Centers of America - Palo Alto — Palo Alto, California, United States
- CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
- University of Miami — Miami, Florida, United States
- University of South Florida Parkinson's and Movement Disorders Center — Tampa, Florida, United States
- Consultants in Neurology, Ltd — Northbrook, Illinois, United States
- Josephson Wallack Munshower Neurology - Southeast — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Quest Research Institute — Farmington Hills, Michigan, United States
- Parkinson's Research Centers of America - Long Island — Commack, New York, United States
- NYU Langone Health — Patchogue, New York, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Central Texas Neurology Consultants — Round Rock, Texas, United States
Full record on ClinicalTrials.gov
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