TB006 for Parkinson's Disease

Recruiting at 11 trial locations

Overseen By TrueBinding, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: TrueBinding, Inc.

Must be taking: Levodopa-carbidopa

Must not be taking: Investigational drugs

Disqualifiers: Severe psychiatric disorders, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TB006 to determine its safety and effectiveness in improving movement for people with Parkinson's Disease. The study includes two groups: one receives TB006 through an IV (a method of delivering medicine directly into a vein), and the other receives a placebo (a treatment with no active drug). It seeks participants who have had Parkinson's Disease for less than 5 years, show some improvement with levodopa medication, and have mild symptoms. This trial may suit those without severe health issues or sudden medication OFF episodes and who lack a history of severe infusion reactions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require participants to be on immediate-release levodopa-carbidopa/benserazide. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that TB006 is likely to be safe for humans?

Research has shown that TB006 has undergone safety testing in several studies. Most participants in these studies tolerated TB006 well. For example, earlier research found that patients taking TB006 did not experience major side effects.

Another study examined TB006 alongside a similar treatment called zuranolone. This similar treatment was also generally well tolerated, which increases confidence in the safety of TB006.

Since TB006 remains in Phase 2 studies, it is important to note that it has passed earlier safety tests but continues to be carefully monitored for any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

TB006 is unique because it offers a fresh approach for treating Parkinson's Disease. Unlike standard treatments like levodopa or dopamine agonists, which primarily aim to replenish or mimic dopamine, TB006 is administered via intravenous infusion and may work by targeting different pathways in the brain. This new method could potentially lead to more effective management of symptoms and possibly slow disease progression, which is why researchers are eagerly exploring its potential.

What evidence suggests that TB006 might be an effective treatment for Parkinson's Disease?

Research has shown that TB006 could help treat Parkinson's Disease. In one study, almost half of the Parkinson's patients who used TB006 for three months or more experienced improvements in their condition or brain function. Another study found that TB006 might help predict and enhance movement abilities, crucial for people with Parkinson's. These findings suggest that TB006 may effectively boost movement and thinking skills in those with Parkinson's Disease. Participants in this trial will receive either TB006 or a placebo via intravenous infusion to further evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease diagnosed within the last 5 years, showing motor improvement from levodopa. They must have mild symptoms and be on immediate-release levodopa-carbidopa/benserazide. Participants should not have active cancer (except certain skin cancers), significant health issues that could affect study participation, or use illegal drugs.

Inclusion Criteria

My Parkinson's disease is in its early stages with mild symptoms.

Free of significant health issues that might interfere with study participation

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

Exclusion Criteria

Allergies or sensitivities to specific study-related treatments or substances

I experience sudden loss of medication effects for Parkinson's.

Any condition or health concern deemed a safety risk or likely to interfere with study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TB006 or placebo via intravenous infusion to assess efficacy in improving motor function and safety in Parkinson's Disease

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TB006

Trial Overview The trial is testing TB006's effectiveness in improving motor function in Parkinson's patients compared to a placebo. It aims to assess both how well TB006 works and its safety profile.

How Is the Trial Designed?

Group I: TB006 Experimental Treatment 1 Intervention

Participants will receive TB006 via intravenous (IV) infusion.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo via IV infusion.

Who Is Running the Clinical Trial?

TrueBinding, Inc.

Lead Sponsor

Trials

7

Recruited

440+

Published Research Related to This Trial

In a multicenter, double-blind, placebo-controlled trial involving 210 patients with early Parkinson's disease, pioglitazone did not show a meaningful effect on disease progression compared to placebo, suggesting it is unlikely to modify the disease.

Both doses of pioglitazone (15 mg and 45 mg) failed to demonstrate significant efficacy, with the study concluding that further research on pioglitazone for Parkinson's disease is not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial. [2018]

A consensus was reached among 92 stakeholders, including people with Parkinson's and clinical scientists, on key aspects of phase 3 trials for Parkinson's disease, highlighting the importance of inclusive trial designs and holistic outcome measures.

The study identified 14 critical items for trial design, emphasizing the need for diverse perspectives in developing effective disease modification trials, which can help improve the success of future research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson's Disease Trials. Zeissler, ML., McFarthing, K., Raphael, KG., et al.[2023]

Safinamide, when used as an add-on therapy for Parkinson's disease, significantly reduces 'off-time' and increases 'on time without troublesome dyskinesia', showing its efficacy in managing motor complications associated with anti-Parkinson's medications.

The study found no significant difference in adverse events between the safinamide and placebo groups, suggesting that safinamide is a safe option for patients, although further research is needed due to some studies having a high risk of bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of safety and efficacy of safinamide for motor fluctuations in patients with Parkinson's disease. Abdelalem Aziz Ahmed, M.[2020]

In a study of 511 Spanish patients with Parkinson's Disease, safinamide demonstrated a favorable safety profile and led to significant improvements in motor function, with 57.4% of patients showing clinically meaningful benefits when used as an add-on to levodopa.

Motor complications decreased from 83.2% to 63.3% over the study period, indicating safinamide's efficacy in managing symptoms, although caution is advised for patients with cognitive impairment due to a slightly higher frequency of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: post-hoc analysis of the Spanish study population. Kulisevsky, J., Esquivel, A., Freire-Álvarez, E., et al.[2023]

In a retrospective analysis of 113 patients with advanced Parkinson's disease, treatment with levodopa-carbidopa intestinal gel (LCIG) significantly improved motor symptoms, increasing the 'on' period by an average of 6.14 hours and reducing dyskinesia by 29.4%.

Patients reported significant improvements in their quality of life after starting LCIG therapy, with few adverse events noted, indicating that LCIG is a safe and effective treatment option for managing advanced Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of levodopa-carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson's disease: a multicenter Romanian experience. Băjenaru, O., Ene, A., Popescu, BO., et al.[2022]

The Linked Clinical Trials (LCT) initiative, established in 2011, focuses on repurposing existing drugs to slow the progression of Parkinson's disease, with a scientific committee that has prioritized candidate drugs since 2012.

The initiative has led to 10 clinical trials targeting various therapeutic areas, including glucagon-like peptide 1 receptor and iron, demonstrating a significant effort to find effective treatments for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Linked Clinical Trials initiative (LCT) for Parkinson's disease. Brundin, P., Wyse, RK.[2020]

A pilot trial involving 39 non-demented patients with Parkinson's disease showed that occupational therapy (OT) is feasible and acceptable, with low withdrawal rates and good completion of outcome questionnaires.

The study indicated that OT may improve functional independence and quality of life, as measured by the Nottingham Extended Activity of Daily Living Scale and the Parkinson's Disease Questionnaire, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial. Clarke, CE., Furmston, A., Morgan, E., et al.[2021]

A multidisciplinary rehabilitation program for people with Parkinson's disease showed a trend towards improved mobility, as indicated by better stand-walk-sit scores, although it did not significantly enhance overall health or quality of life after six months.

Despite some short-term benefits in mobility, both patients and their carers experienced a decline in disability and quality of life over six months, suggesting that ongoing treatment may be necessary to sustain any improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary rehabilitation for people with Parkinson's disease: a randomised controlled study. Wade, DT., Gage, H., Owen, C., et al.[2022]

In a 7-day open-label study involving 14 patients with Parkinson's disease, zuranolone significantly reduced tremor symptoms by 40%, indicating its potential efficacy as a treatment for this challenging symptom that is often resistant to standard dopamine therapy.

Zuranolone was well tolerated with no serious adverse events reported, and common side effects included dizziness and sedation, suggesting it may be a safe adjunctive treatment for managing tremors in patients already on dopaminergic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study. Bullock, A., Kaul, I., Li, S., et al.[2021]

A study involving 204 Parkinson's disease patients identified effective predictor algorithms that significantly improve the prediction of motor outcomes using clinical measures and dopamine-transporter imaging data.

The combination of longitudinal motor measures and advanced feature selection techniques led to a highly accurate prediction model, achieving a low error rate of 4.15, indicating the potential for better clinical trial design in testing new therapies for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning methods for optimal prediction of motor outcome in Parkinson's disease. Salmanpour, MR., Shamsaei, M., Saberi, A., et al.[2020]

Citations

1. withpower.com withpower.com/trial/tb006-for-parkinsons-disease-681bd

TB006 for Parkinson's Disease A study involving 204 Parkinson's disease patients identified effective predictor algorithms that significantly improve the prediction of motor outcomes using ...

2. ctv.veeva.com ctv.veeva.com/study/a-phase-2a-multicenter-clinical-trial-of-tb006-in-participants-with-parkinsons-disease

A Phase 2a Multicenter Clinical Trial of TB006 in Participants ... 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 ...

3. truebinding.com truebinding.com/news

News — TrueBinding Nearly half of the patients treated with TB006 for three months or longer showed signs of disease reversal or cognitive improvement. The study builds upon ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05476783

NCT05476783 | A Long Term Extension Study to Assess ... The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TB006.

5. trial.medpath.com trial.medpath.com/clinical-trial/143884326fe87688/nct06773962-tb006-parkinsons-disease-study

A Phase 2a Multicenter Clinical Trial of TB006 in Participants ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05074498

NCT05074498 | Study to Assess the Safety, Tolerability, ... Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the ...

7. truebinding.com truebinding.com/

TrueBinding TrueBinding has cleared an FDA IND application for TB006 for potential disease modification of Parkinson's Disease. A multi-center, placebo-controlled, Phase 2A ...