Sunday, August 7, 2022

Parkinson’s Phase 3 Trials

Dual Frequency Stimulation In Parkinson’s Disease

What is a Parkinson’s clinical trial?

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Deep brain stimulation in the dorsal region of the subthalamic nucleus is very effective for reducing motor symptoms of Parkinson’s disease . Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with PD.

at UC Davis

Study To Assess Adverse Events And Change In Disease Activity Of 24

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Parkinson’s disease is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational drug containing levodopa/carbidopa given as an infusion under the skin for the treatment of Parkinson’s Disease. Adult participants with advanced PD and who have completed M15-736 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion of ABBV-951 for 96 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

at UCLAUCSD

Chronic Effects Of Dbs In Parkinson’s Disease And Dystonia

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The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.

San Francisco, California

  • Sorry, in progress, not accepting new patients

    This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson’s disease patients.

    San Francisco, California

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    Birtamimab Phase 3 Affirm

    Phase 3 trial of exenatide for Parkinsons starting soon ...

    Birtamimab is a humanized monoclonal antibody under investigation for the treatment of AL amyloidosis in patients categorized as Mayo Stage IV. The confirmatory Phase 3 registration enabling AFFIRM-AL study evaluating the efficacy and safety of birtamimab in Mayo Stage IV patients with AL amyloidosis has initiated under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration .

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    Intec Pharma’s Accordian Pill

    Background: Levodopa remains the most potent symptomatic therapy for PD. One of the major limitations of levodopa therapy is the risk of development of motor fluctuations and dyskinesia related to the short half life of the drug, coupled with progressive decline of neuronal dopamine storage capacity. Current formulations of levodopa are generally taken every few hours, leading to a pulsatile profile of peaks and troughs. The peaks can induce troublesome dyskinesia while the troughs can lead to OFF time with significant symptom breakthrough. A steadier and more consistent plasma profile should reduce the incidence of both types of motor fluctuation as well as reducing the number of tablets patients need to take. Intec Pharma have developed the Accordion Pill, a gastric-retentive capsule containing multiple layers of both immediate release and controlled release levodopa and carbidopa. The pill remains in the stomach for up to 12 hours. READ MORE

    Cerevel Therapeutics Initiates Phase 3 Program Of Tavapadon For The Treatment Of Parkinsons Disease

    Studies to Enroll Approximately 1,200 Patients to Determine Effectiveness of Tavapadon Across the Full Spectrum of Early- and Late-Stage Parkinsons

    BOSTON January 14, 2020 Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced the initiation of its registration-directed Phase 3 program evaluating tavapadon in patients with Parkinsons disease. The company plans to conduct three 27-week trials designed to evaluate the efficacy, safety and tolerability of fixed doses and flexible doses of tavapadon as either monotherapy in patients with early-stage Parkinsons disease or as adjunctive therapy to levodopa in patients with late-stage Parkinsons disease who are experiencing motor fluctuations. A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

    In each of the three 27-week trials, participants will be randomized to tavapadon or placebo groups. In the TEMPO-1 trial, study participants will be titrated up to a fixed dose of either 5 mg once daily or 15 mg QD of tavapadon. In the TEMPO-2 and TEMPO-3 trials, participants will be titrated upward to a dose of between 5 mg and 15 mg QD in a flexible dosing paradigm.

    The TEMPO-1 and TEMPO-2 trials have already initiated screening of patients, and the TEMPO-3 trial will begin screening later this year.

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    Deep Brain Stimulation For The Treatment Of Parkinson’s Disease

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific’s Vercise Deep Brain Stimulation system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson’s disease which is not adequately controlled with medication.

    San Francisco, California

  • Sorry, accepting new patients by invitation only

    An extension study for participants who have completed a prior VY-AADC01 clinical study

    San Francisco, California

  • Adaptive Deep Brain Stimulation To Improve Motor And Gait Functions In Parkinson’s Disease

    How crucial is phase 3 in vaccine clinical trials?

    Sorry, accepting new patients by invitation only

    This is a single-center phase I clinical study aiming to improve gait functions in patients with Parkinson’s disease by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) decode the physiological signatures of gait and gait adaptation by recording neural activities from the motor cortical areas and the globus pallidus during natural walking and a gait adaptation task, and 2) develop an adaptive deep brain stimulation paradigm to selectively stimulate the pallidum during different phases of the gait cycle and measure improvements in gait parameters. This is the first exploration of network dynamics of gait in PD using chronically implanted cortical and subcortical electrodes. In addition to providing insights into a fundamental process, the proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance locomotor skills in patients with PD. Ten patients with idiopathic Parkinson’s disease undergoing evaluation for DBS implantation will be enrolled in this single treatment arm study.

    San Francisco, California

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    Inosine Fails To Slow Early Parkinson Disease Progression In Phase 3 Trial

      Urate-elevating inosine treatment had no beneficial effect on the rate of clinical disease progression among patients with newly diagnosed Parkinson disease , according to study results published in JAMA.

      Prior studies have suggested that urate, the main antioxidant circulating in human plasma, may play a role in disease progression among patients with PD, prompting a phase 2 trial of oral inosine, a metabolic precursor of urate that was shown to be safe and tolerable. The objective of the current phase 3 trial was to assess the impact of inosine on disease progression in patients with early PD.

      The randomized, double-blind, placebo-controlled trial included 298 patients with PD from 58 US sites. Study participants were randomized to receive inosine or placebo .

      The primary outcome was the rate of clinical progression in early PD after 2 years, according to rate of change in the Movement Disorder Society Unified Parkinson Disease Rating Scale total score, prior to initiating dopaminergic drug therapy.

      In September 2018, the data and safety monitoring board reviewed the second prespecified, nonbinding interim analysis for early stopping due to efficacy or futility of inosine treatment and as the results met the prespecified criterion for futility, the study was closed early with 273 of the randomized participants completing the study.

      Serious adverse events were more common in the placebo group , but kidney stones were more common among patients treated with inosine .

      Reducing Calcium Levels In The Brain

      Isradipine is a calcium channel blocker usually prescribed for the treatment of high blood pressure, in order to reduce the risk of stroke and heart attack. It was thought that isradipine might be protective in Parkinson’s because the affected dopamine-producing brain cells are continuously flooded with calcium, which is believed to contribute to damaging oxidative stress and ultimately cell death.

      Following promising results in animal models and small-scale clinical trials, in 2014, researchers in the US received $23 million to conduct a phase 3 trial of isradipine in 336 people with Parkinson’s.

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      Effects Of Osteopathic Manipulative Treatment On Gait Biomechanics In Parkinson’s Disease

      Sorry, in progress, not accepting new patients

      Parkinson’s disease is a neurological disorder that puts individuals at high risk for injuries and long-term disabilities as a result of a fall or other trauma. Injuries sustained from falls account for many deaths as well as thousands of hospital admissions and nursing home stays every month. Quality of life and even longevity itself is reduced due to the resulting surgeries, immobility, complications and even cognitive impairments that can follow. The proposed study will explore beneficial impact of a treatment modality that may significantly reduce the morbidity of this condition by comparing 6 weeks of OMT versus 6 weeks light touch intervention versus 6 weeks care as usual to improve gait in individuals with PD. Gait will be measured at mid-treatment, post-treatment and 4-week follow-up.

      at UCSD

      First Participant Treated In Phase 3 Trial Of Tavapadon For Motor Symptoms Of Parkinson Disease

      Phase III IPF Clinical Trials
      • Parkinson disease
      • Tavapadon

      Tavapadon has been shown in phase 2 trials to reduce improve motor symptoms of Parkinson disease as measured with the in Unified Parkinson’s Disease Rating Scale Part III. Tavapadon is a D1 and D5 dopamine receptor partial agonist taken orally once daily. Currently available drugs for better motor control, in contrast, work at the D2 and D3 dopamine receptors.

      The first participants have been dosed in all 3 clinical trials in a phase 3 program evaluating tavapadon. Approximately 1,200 individuals age 40 to 80 will be enrolled across all 3 trials. The primary endpoint of the TEMPO-1 and TEMPO-2 trials is the change from baseline in the MDS-UPDRS part 2 and part 3 combined score. The TEMPO-3 trial will measure change from baseline in total daily ON time without troublesome dyskinesia. A fourth 58-week, open-label, safety extension trial will also be conducted as part of the program.

      We are encouraged by the benefit-risk profile of tavapadon based on the efficacy results observed in phase 2 trials, as well as the tolerability profile we have seen in our clinical program to date, said Raymond Sanchez, MD, chief medical officer of Cerevel Therapeutics. We look forward to advancing the development of tavapadon and potentially bringing a differentiated, cornerstone therapy to individuals with PD at all stages of the disease as supported by a robust phase 3 program.

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      Infusion Of Apomorphine: Long

      Sorry, in progress, not accepting new patients

      This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson’s Disease whose motor fluctuations remain unsatisfactory with levodopa and at least one other class of drugs or mode of therapy for PD.

      at UCLA

      Parkinsons Disease Drug Therapies In The Clinical Trial Pipeline: 2020

      Article type: Review Article

      Authors: McFarthing, Kevina | Buff, Sueb | Rafaloff, Garyc | Dominey, Thead | Wyse, Richard K.d | Stott, Simon R.W.d *

      Affiliations: Parkinsons Research Advocate, Oxford, UK | Parkinsons Research Advocate, Sunnyvale, CA, USA | Parkinsons Research Advocate, Marlboro, NJ, USA | The Cure Parkinsons Trust, London, UK

      Correspondence: Correspondence to: Simon R.W. Stott, The Cure Parkinsons Trust, 120 New Cavendish Street, London. E-mail: .

      Keywords: Clinical trials, studies, Parkinsons, disease modification, neuroprotection, immunotherapy, inflammation, gene therapy

      DOI: 10.3233/JPD-202128

      Journal: Journal of Parkinson’s Disease, vol. 10, no. 3, pp. 757-774, 2020

      Abstract

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      Exenatide The Journey So Far

      Exenatide works by targeting a receptor in the pancreas called GLP-1 which triggers insulin release. Crucially these receptors are also present inside the brain and research in the lab has suggested they play a role in a variety of processes that may be beneficial or protective for the brain cells affected in Parkinsons.

      Encouraging results from the lab quickly led to the first clinical trial in 2010 a small 12 month study in 45 people with Parkinsons. The results, published in 2013, showed that participants who received the drug had improved slightly over the 12 months of the study, whereas those in the control group had experienced a slight decline in their condition.

      However, because people in the control group did not receive a placebo , these promising findings could have been down to the placebo effect.

      To investigate further a phase 2 double-blind, placebo-controlled study involving 60 people began in 2014. The results, published in 2017, again showed that those who received exenatide improved slightly over the course of the study, whereas those who received placebo deteriorated, when their movement symptoms were assessed while off their usual Parkinsons medications.

      Another perplexing finding was that people who received exenatide did no better than those who received placebo on other important assessments including quality of life and non-motor symptoms such as mood, memory and thinking.

      What Emerging Drug Therapies Are In The Clinical Trial Pipeline For Parkinson Disease

      BioVie: Near-Term Catalysts from Phase 2 & Phase 3 Trials

      Overall, there are 145 registered and ongoing clinical trials for therapies targeting Parkinson disease, of which 28 are currently in phase 3, according to review findings.

      Overall, there are 145 registered and ongoing clinical trials for therapies targeting Parkinson disease , of which 28 are currently in phase 3, according to review findings published in the Journal of Parkinson Disease.

      In the second half of the last century, researchers highlight that the majority of pharmacological treatments approved for clinical use only provide symptomatic relief as opposed to slowing or reversing the progression of PD. In examining the current evolution of potential pharmacological interventions within PD, they note that a number of similar treatments to those already approved are being assessed in current clinical trials.

      While additionally accounting for these therapies tailored toward symptomatic issues, the researchers sought to create greater awareness toward disease modifying therapies in the current state of clinical trials within PD. They conducted a review and breakdown analysis of clinical trials for drug therapies in PD that were active as of January 21, 2020.

      Of the 145 registered and ongoing clinical trials for therapies targeting PD, 37 were phase 1, 14 were phase 1/2, 61 were phase 2, 5 were phase 2/3, and 28 were phase 3.

      Reference

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      Study To Identify Clinical Imaging And Biologic Markers Of Parkinson Disease Progression

      Sorry, in progress, not accepting new patients

      This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease patients compared to healthy controls and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

      San Francisco, California

      Benefits And Risks Of Clinical Trials

      Participating in a clinical trial can be a rewarding experience. Consider the following benefits when deciding if you should join a clinical trial:

      • You will have access to leading healthcare professionals, cutting-edge new treatments and high standards of care.
      • Joining a clinical trial can increase your knowledge and understanding of your disease.
      • People who take part in clinical trials are contributing to science that may benefit themselves and others. The medications that you take now are available only because people before you have volunteered in clinical trials.

      Although every effort is made to ensure that clinical trials are as safe as possible, clinical trials that test new therapies are experiments and can involve risks.

      Here are some of the risks to consider:

      • There may be undesirable side effects to the treatment. A health professional will explain possible risks and side effects during the informed consent process.
      • The treatment may not be effective for the participant.

      Read Also: Parkinson’s Quality Of Life

      Dipraglurant For The Treatment Of Patients With Parkinson’s Disease Receiving Levodopa

      open to eligible people ages 30-85

      This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia for 12 weeks . The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale . Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

      at UC Irvine

      Amneal Announces Positive Topline Results From Pivotal Phase 3 Rise

      Phase III Trials of Targeted Anticancer Therapies ...

      Amneal Pharmaceuticals, Inc. announced positive results from the Phase 3 RISE-PD clinical trial that evaluated the novel formulation, IPX-203, in patients with Parkinsons disease who have motor fluctuations. The trial demonstrated superior Good On time at the conclusion of a 13-week double-blind treatment period. Amneal plans to submit a New Drug Application for IPX-203 with the U.S. Food and Drug Administration in mid-2022. to learn more about Amneal and IPX-203.

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