RECRUITING

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

Conditions

Parkinson's Disease (PD)PD TB006 Monoclonal Antibody Parkinson's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants with Parkinson's Disease

Quick Facts

Study Start:2025-01-24

Study Completion:2025-12-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06773962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 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. 8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.	1. History of sudden, unexpected PD medication OFF episodes. 2. Severe motor complications or disabling symptoms that may impact study involvement. 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. 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.

Inclusion Criteria

Exclusion 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.
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.
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.
8. Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.

1. History of sudden, unexpected PD medication OFF episodes.
2. Severe motor complications or disabling symptoms that may impact study involvement.
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.
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.

Contacts and Locations

Study Contact

TrueBinding, Inc.

CONTACT

650-847-1117

clinicaltrial@truebinding.com

Study Locations (Sites)

Josephson Wallack Munshower Neurology - Southeast

Indianapolis, Indiana, 46256

United States

Collaborators and Investigators

Sponsor: TrueBinding, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24

Study Completion Date2025-12-29

Study Record Updates

Study Start Date2025-01-24

Study Completion Date2025-12-29

Terms related to this study

Keywords Provided by Researchers

PD
TB006
Monoclonal Antibody
Parkinson's Disease

Additional Relevant MeSH Terms

Parkinson's Disease (PD)