- |||||||||| Inbrija (levodopa inhalation powder) / Merz Pharma
Novel In-Clinic Use of Levodopa Inhalation Powder (CVT-301) as an Outpatient Diagnostic Tool for Parkinson's Disease (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1004;
At that same initial visit,L-dopa-responsive patients were prescribed oral Carbidopa/Levodopa & its effectiveness was evaluated at follow-up. Although inhaled levodopa CVT-301 was developed for "on-demand" treatment of sudden motor-OFF periods in PD,4 there is potential for the novel in-clinic use of this quick- acting dopaminergic drug as a tool to expedite the diagnosis of PD without any clinically significant adverse events.
- |||||||||| If Oral Levodopa is not Possible, Keep Calm and Breathe Deeply (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1000;
His treatment at that time was oral levodopa divided into 6 doses, safinamide, rivastigmine and, for delayed ON in the morning and for unpredictable OFF, inhaled levodopa had been prescribed. He had presented intolerance to opicapone, rasagiline and dopamine agonists, the latter with impulse control disorder and hallucinations at low doses...
- |||||||||| Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Aug 7, 2024
P=N/A, N=120, Recruiting,
He had presented intolerance to opicapone, rasagiline and dopamine agonists, the latter with impulse control disorder and hallucinations at low doses... Trial completion date: Dec 2024 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2027
- |||||||||| Levodopa Cyclops / PUREIMS, Inbrija (levodopa inhalation powder) / Merz Pharma
Trial completion, Trial completion date, Trial primary completion date: DPI-6: Usability of Levodopa Cyclops (clinicaltrials.gov) - Jul 24, 2024
P=N/A, N=16, Completed,
Trial completion date: Dec 2024 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2027 Recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Nov 2024 --> Jul 2024
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Inhaled levodopa: from evidence to experience (Pubmed Central) - Jun 25, 2024
The choice for each patient will depend on their individual needs and circumstances. To mark the first year of the introduction of inhaled levodopa, we review these therapies, focusing on the experience with this new dosage form of levodopa.
- |||||||||| Levodopa Cyclops / PUREIMS, Inbrija (levodopa inhalation powder) / Merz Pharma
Enrollment open: DPI-6: Usability of Levodopa Cyclops (clinicaltrials.gov) - May 28, 2024
P=N/A, N=16, Recruiting,
To mark the first year of the introduction of inhaled levodopa, we review these therapies, focusing on the experience with this new dosage form of levodopa. Not yet recruiting --> Recruiting
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Journal: Dopamine and its precursor levodopa inactivate SARS-CoV-2 main protease by forming a quinoprotein. (Pubmed Central) - May 26, 2024
CVT-301 (orally inhaled levodopa) was approved by the FDA as a drug for Parkinson's patients prior to the outbreak of COVID-19 in 2018. Based on the fact that SARS-CoV-2 causes inefficient replication in the CNS with abundant endogenous Mpro inhibitor in addition to the current finding that levodopa has an Mpro-inhibitory effect somewhat stronger than dopamine, we should urgently investigate the use of CVT-301 as a lung-targeting, COVID-19, Mpro inhibitor.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
1101 Advanced Therapies in Parkinson () - Jan 30, 2024 - Abstract #MDSPAS2024MDS_PAS_1;
Based on the fact that SARS-CoV-2 causes inefficient replication in the CNS with abundant endogenous Mpro inhibitor in addition to the current finding that levodopa has an Mpro-inhibitory effect somewhat stronger than dopamine, we should urgently investigate the use of CVT-301 as a lung-targeting, COVID-19, Mpro inhibitor. Review the implications of the latest clinical trials aiming to translate infusion therapies for patients with Parkinson
- |||||||||| Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Jan 9, 2024
P=N/A, N=120, Recruiting,
Review the implications of the latest clinical trials aiming to translate infusion therapies for patients with Parkinson Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Levodopa Cyclops / PUREIMS, Inbrija (levodopa inhalation powder) / Merz Pharma
Trial completion date, Trial primary completion date: DPI-6: Usability of Levodopa Cyclops (clinicaltrials.gov) - Oct 24, 2023
P=N/A, N=16, Not yet recruiting,
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Nov 2024
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Drugs to the Rescue: Comparison of On-Demand Therapies for OFF Symptoms in Parkinson's Disease. (Pubmed Central) - Jun 20, 2023
We compare the current marketed options: subcutaneous apomorphine, sublingual apomorphine, and inhaled levodopa...The best choice for a patient will depend on individual needs and circumstances. In this review, we explore those nuances to allow clinicians to select the best option for their patients.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Inhaled levodopa for threatening impending OFF episodes in managing Parkinson's disease. (Pubmed Central) - May 22, 2023
Inhaled levodopa powder was also approved for early morning Off episodes. The aim of this review article is to give an overview of the different clinical studies of the innovative inhaled levodopa powder, a new on-demand therapy to treat Off episodes in PD.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Pharmacological Treatment of Tremor in Parkinson's Disease Revisited. (Pubmed Central) - Mar 24, 2023
Treating motor fluctuations with MAO-B and COMT inhibitors, dopamine agonists, amantadine, or on-demand treatments such as subcutaneous or sublingual apomorphine and inhaled levodopa as well as with continuous infusions of levodopa or apomorphine will improve off period tremor episodes...Surgery can also be highly effective for the treatment medication-refractory tremor in selected patients without motor fluctuations. The present review highlights the clinical essentials of parkinsonian tremor, critically examines available trial data on the effects of medication and surgical approaches and provides guidance for the choice of treatments to control PD tremor in clinical practice.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Journal: The Clinical Development of Levodopa Inhalation Powder. (Pubmed Central) - Mar 15, 2023
Levodopa inhalation powder 84 mg increased plasma levodopa concentration rapidly and with less variability than oral levodopa/carbidopa (25/100 mg). Most common adverse event associated with levodopa inhalation powder is cough, found in ~15% of patients in the SPAN-PD trial; otherwise, reported adverse events were consistent with those known to be associated with oral levodopa.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: A Review of Levodopa Formulations for the Treatment of Parkinson's Disease Available in the United States. (Pubmed Central) - Jan 28, 2023
Additionally, there is a levodopa inhalation powder available...Consequently, while this expansion of levodopa formulations has substantially increased treatment options for patients, it has also increased the complexity of medical decision making for patients, providers, and health systems alike. Knowledge of the different pharmacokinetic, safety and efficacy profiles of the available levodopa formulations is critical for the effective management of Parkinson's disease on both the individual patient and population levels.
- |||||||||| Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Jan 18, 2023
P=N/A, N=120, Recruiting,
Knowledge of the different pharmacokinetic, safety and efficacy profiles of the available levodopa formulations is critical for the effective management of Parkinson's disease on both the individual patient and population levels. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Esteve: Management of OFF episodes with inhaled levodopa (London 1) - Oct 20, 2022 - Abstract #DGN2022DGN_239;
With inhaled levodopa, which is used as an on-demand therapy in the form of a levodopa Dry powder and inhaled with the help of a special inhaler, off-episodes can be overcome quickly with a well-known active ingredient and its well-known safety profile, while at the same time bypassing swallowing difficulties and the gastrointestinal tract. The inhaled levodopa is approved for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson's disease receiving levodopa/DDCI.
- |||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, Aquestive, BIAL, Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: Should "on-demand" treatments for Parkinson's disease OFF episodes be used earlier? (Pubmed Central) - Aug 30, 2022
Three "on-demand" treatments are currently available in the US as follows: subcutaneous apomorphine, levodopa inhalation powder, and sublingual apomorphine...Novel "on-demand" treatments bypass the gut and can improve OFF symptoms more rapidly and reliably than oral levodopa. With the emergence of novel "on-demand" treatments, we conclude that a shift in treatment paradigm to the earlier, complementary use of these medications be considered.
- |||||||||| Levodopa Cyclops / PUREIMS, Inbrija (levodopa inhalation powder) / Merz Pharma
New trial: DPI-6: Usability of Levodopa Cyclops (clinicaltrials.gov) - Aug 12, 2022
P=N/A, N=16, Not yet recruiting,
- |||||||||| Enrollment open, Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Mar 2, 2022
P=N/A, N=120, Recruiting,
In these subpopulations of patients experiencing OFF periods in SPAN-PD, CVT-301 was effective in improving motor function and patient-reported impression of change. Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Clinical, Journal: Natural history of lung function over one year in patients with Parkinson's disease. (Pubmed Central) - Dec 16, 2021
P3
PD patients had greater declines in FEV, and FVC, but not in DL compared to healthy non-smokers of similar age. Declines in FEV and FVC with little change in FEV/FVC, and decline in VA and IVC with little change in DL/VA, suggest these changes were due to decreases in lung volume and are compatible with progressive PD-associated respiratory muscle weakness.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Clinical, Journal: Levodopa inhalation powder in a patient with persistent asthma. (Pubmed Central) - Oct 6, 2021
Exploratory efficacy results showed CVT-301 maintained improvement at achieving ON states in patients experiencing OFF episodes, decreasing daily OFF time, and maintaining improvement in PGIC. No abstract available
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda, Duodopa (levodopa/carbidopa intraduodenal gel infusion) / AbbVie
Clinical, Journal: On demand therapy for Parkinson's disease patients: opportunities and choices. (Pubmed Central) - Sep 17, 2021
On demand therapy is now available for patients experiencing episodic or intermittent need for rapid and reliable onset of benefit. On demand therapy may also provide an alternative to more invasive treatment such as infusion of levodopa/carbidopa intestinal gel and for patients whose OFF episodes are not controlled despite deep brain stimulation.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Clinical, Review, Journal: Clinical implications of gastric complications on levodopa treatment in Parkinson's disease. (Pubmed Central) - Aug 14, 2021
Therapeutic strategies devised to minimize the potential that gastric complications will impair oral levodopa absorption and efficacy in PD patients include treatments that circumvent the GI tract, such as apomorphine injection, levodopa intestinal gel delivery, levodopa inhalation powder, and deep brain stimulation. Other strategies aim at improving gastric emptying in PD patients, primarily including prokinetic agents.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Review, Journal: On-Demand Therapy for OFF Episodes in Parkinson's Disease. (Pubmed Central) - Aug 8, 2021
Other strategies aim at improving gastric emptying in PD patients, primarily including prokinetic agents. There are now 3 therapies that are available for the on-demand treatment of OFF episodes; subcutaneous injection of apomorphine, sublingual apomorphine film, and inhaled levodopa...This review will consider the currently available on-demand therapies and their potential advantages and disadvantages.
- |||||||||| New trial, Surgery: Motor Network Physiology (clinicaltrials.gov) - Jul 12, 2021
P, N=120, Not yet recruiting,
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Clinical, Journal: An evaluation of the efficacy and value of CVT-301 for the treatment of Parkinson's Disease. (Pubmed Central) - Jun 26, 2021
It should be noted that the delivery device used has been described as relatively simple to use, but the few steps required to prepare and self-administer the dose can challenging for PD patients during their OFF state. Additionally, resolution of an OFF episode requires the administration of two capsules of CVT-301, which further complicates the use of the device.
- |||||||||| Inbrija (levodopa inhalation powder) / Acorda
Journal: Inhaled Levodopa as a Potential Treatment for Diphasic Dyskinesia. (Pubmed Central) - Apr 28, 2021
Additionally, resolution of an OFF episode requires the administration of two capsules of CVT-301, which further complicates the use of the device. No abstract available
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