TB006 for Parkinson's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: TrueBinding, Inc.
Must be taking: Levodopa-carbidopa
Must not be taking: Investigational drugs
Disqualifiers: Severe psychiatric disorders, Cancer, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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).
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.
What data supports the effectiveness of the drug TB006 for Parkinson's Disease?
The Linked Clinical Trials initiative has sparked promising clinical trials aimed at slowing Parkinson's disease progression, focusing on drugs targeting specific therapeutic areas. This suggests that repurposing drugs, like TB006, could potentially be effective in treating Parkinson's disease.
12345What safety data exists for TB006 or similar treatments for Parkinson's Disease?
Zuranolone, a treatment similar to TB006, was generally well tolerated in a study with Parkinson's patients, with no serious adverse events reported. The most common side effects were dizziness, sedation, and sleepiness.
678910Eligibility Criteria
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
+5 more
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
+5 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TB006Experimental Treatment1 Intervention
Participants will receive TB006 via intravenous (IV) infusion.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo via IV infusion.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Josephson Wallack Munshower Neurology - SoutheastIndianapolis, IN
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Who Is Running the Clinical Trial?
TrueBinding, Inc.Lead Sponsor
References
The Linked Clinical Trials initiative (LCT) for Parkinson's disease. [2020]The Linked Clinical Trials (LCT) initiative is a drug repurposing programme specifically aimed at identifying drugs that can slow the progression of Parkinson's disease (PD). Tom Isaacs was one of the key people behind the idea of LCT in 2011. He ensured it became a priority of The Cure Parkinson's Trust (CPT), a philanthropic funding body based in the UK which Tom had co-founded 7 years earlier. During the latter 6 years of his life, Tom Isaacs was heavily involved in the LCT initiative and held the programme dear to his heart. This article describes the genesis of LCT and how the LCT scientific committee evaluates candidate drugs. From 2012, this committee has met annually to prioritise drugs suitable for repurposing in PD. This article does not catalogue every clinical trial within the LCT programme, but describes the 10 clinical trials that emerged either directly, or as an offspring from discussions, at the first meeting of the LCT scientific committee. Some, but not all, are funded by CPT, and all 10 trials are now either completed or ongoing. These trials use drugs developed to address one of the four therapeutic targets: glucagon-like peptide 1 receptor, iron, and c-abl tyrosine kinase. We conclude the LCT programme has already sparked a large number of promising clinical trials aimed at slowing PD progression. In doing so, it is a major legacy of Tom Isaacs, carrying the torch he once lit and conveying a sense of urgency for new and life-transforming therapies for people with PD.
Machine learning methods for optimal prediction of motor outcome in Parkinson's disease. [2020]It is vital to appropriately power clinical trials towards discovery of novel disease-modifying therapies for Parkinson's disease (PD). Thus, it is critical to improve prediction of outcome in PD patients.
An International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson's Disease Trials. [2023]Design of disease modification (DM) trials for Parkinson's disease (PD) is challenging. Successful delivery requires a shared understanding of priorities and practicalities.
Multidisciplinary rehabilitation for people with Parkinson's disease: a randomised controlled study. [2022]To determine whether a programme of multidisciplinary rehabilitation and group support achieves sustained benefit for people with Parkinson's disease or their carers.
Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial. [2021]To perform a pilot trial of occupational therapy (OT) to optimise functional independence in Parkinson disease (PD) to assess accrual/withdrawal rates, acceptability, outcome measures, and inform sample-size calculation.
A systematic review and meta-analysis of safety and efficacy of safinamide for motor fluctuations in patients with Parkinson's disease. [2020]Background: Safinamide, a recently developed drug with several mechanisms of action has been investigated as an add-on therapy for Parkinson's disease patients suffering from motor complications due to the usage of anti-Parkinson's medications such as levodopa and dopaminergic drugs. The aim of the study is to investigate the efficacy and safety of Safinamide as add-on therapy for Parkinson's disease patients.   Methods: A computerized literature search was conducted of PubMed, EMBASE, ClinicalTrial.gov and Cochrane Library until August 2019. We selected relevant randomized controlled trials comparing safinamide groups to placebo groups. Relevant outcomes were pooled as mean difference (MD) and risk ratio (RR) using Review Manager 5.3. Results: We found that the overall MD of changes in "off-time" and "on time without troublesome dyskinesia" favored the safinamide group over the placebo group (MD -0.72 h, 95% CI -0.89 to -0.56 and MD 0.71 h, 95% CI 0.52 to 0.90, respectively). Additionally, the overall MD of change in Unified Parkinson's Disease Rating Scale part three (UPDRS III) favored the safinamide group (MD -1.83, 95% CI -2.43 to -1.23). In case of adverse events, the pooled meta-analysis did not favor the safinamide group over the placebo group. Conclusions: In this study, we provide class I evidence about the potential role of safinamide as an add-on therapy for Parkinson's disease patients suffering from motor fluctuations. However, a few included studies did not mention the data of important outcomes. Also, we report high risk of bias in individual studies. Future randomized controlled trials with different doses are recommended to provide more evidence for the efficacy and safety of safinamide as a treatment for motor complications of anti-Parkinson's medications.
The effect of levodopa-carbidopa intestinal gel infusion long-term therapy on motor complications in advanced Parkinson's disease: a multicenter Romanian experience. [2022]Chronic treatment with oral levodopa is associated with an increased frequency of motor complications in the late stages of Parkinson's disease (PD). Continuous administration of levodopa-carbidopa intestinal gel (LCIG-Duodopa(®), Abbott Laboratories), which has been available in Romania since 2009, represents an option for treating patients with advanced PD. Our primary objective was to report changes in motor complications after initiation of LCIG therapy. The secondary objectives were as follows: to determine the impact of LCIG therapy on the daily levodopa dose variation before/and after LCIG, to collect patient self-assessments of quality of life (QoL), and to study the overall tolerability and safety of LCIG administration. A retrospective analysis (2009-2013) of LCIG therapy and the experience in nine neurology centers in Romania was performed. The impact of LCIG therapy was evaluated by analyzing changes in motor fluctuations, dyskinesia and the patients' QoL after initiating therapy. The safety of LCIG therapy was estimated by noting agent-related adverse events (AEs) and medical device-related AEs. In the 113 patients included, we observed a significant improvement in PD symptoms after initiation of LCIG therapy. The "on" period increased, with a mean value of 6.14 h, and the dyskinesia period was reduced, with a mean value of 29.4 %. The quantified non-motor symptoms subsided. The patients exhibited significant improvements in QoL scores. There were few AEs and few cases of LCIG therapy discontinuation. LCIG is an important and available therapeutic option for managing patients with advanced PD.
Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study. [2021]Parkinson's disease (PD) is characterized by both motor and nonmotor deficits. Among cardinal symptoms of this disorder, tremor is the least responsive to dopamine replacement therapy and is often undertreated. Zuranolone (SAGE-217) is an investigational oral neuroactive steroid (NAS) gamma-aminobutyric acid A (GABAA) receptor-positive allosteric modulator (PAM) that has been investigated for its safety and efficacy in patients with PD. In the current open-label study, zuranolone capsules (20 to 30 mg) were administered for 7 days in 14 patients (mean age, 65.1 years; mean time since PD diagnosis, 9 years). The primary efficacy endpoint was reduction in tremor symptoms, as assessed by change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Tremor Scores on Day 8. Additional endpoints included improvements in overall motor symptoms, and motor and nonmotor aspects of daily living. Adverse events (AEs) were also monitored. The MDS-UPDRS Part II/III Tremor Score improved by 40% (P < 0.0001) from baseline on Day 8. The motor score, and nonmotor experiences of daily living (nM-EDL), and motor experiences of daily living (m-EDL) scores (MDS-UPDRS Parts I and II, respectively), also improved on Day 8. No serious AEs were reported, and no patients discontinued treatment. The most common AEs were dizziness, sedation, and somnolence. Zuranolone was generally well tolerated and improved tremor symptoms in patients with PD who were on stable doses of concurrent dopaminergic agents. These data support the further investigation of NAS GABAA receptor PAMs as adjunctive treatments for tremor in patients with PD.
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. [2023]Parkinson's Disease (PD) is a progressive age-related neurodegenerative condition requiring new therapeutic alternatives. Safinamide, a novel levodopa add-on therapy, positively affects disease fluctuations by modulating both dopaminergic and glutamatergic systems. To further investigate the use of safinamide in European routine clinical practice, the present post-hoc analysis aimed to understand safinamide's safety profile within the Spanish study population.
Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial. [2018]A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial.