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- | Inbrija (levodopa inhalation powder) / Merz Pharma
Journal: Overcoming Absorption Issues: Success with Inhaled Levodopa in a Gastrectomized PD Patient. (Pubmed Central) - Apr 5, 2025
No abstract available
- | Inbrija (levodopa inhalation powder) / Merz Pharma
Journal: Therapeutic effect of an inhaled levodopa dry powder formulation on off episodes in patients with Parkinson's disease. (Pubmed Central) - Nov 1, 2024
Now, it is registered in the OMON with the same identification number (NL6876, Effectiveness of inhaled levodopa in PD | Research with human participants (onderzoekmetmensen.nl)). All patients provided written informed consent.
- | Inbrija (levodopa inhalation powder) / Merz Pharma, Duodopa (levodopa/carbidopa intraduodenal gel infusion) / AbbVie
Journal: Hope vs. Hype III: Rescue/on-demand therapies are preferable to device-assisted therapies in Parkinson disease. (Pubmed Central) - Sep 3, 2024
All patients provided written informed consent. No abstract available
- Inbrija (levodopa inhalation powder) / Merz Pharma, Duodopa (levodopa/carbidopa intraduodenal gel infusion) / AbbVie
Measuring Motor Improvement with a Wearable Device in a Parkinson Disease Patient undergoing Subcutaneous Levodopa Carbidopa Infusion (Poster Hall (Exhibit Hall A)) - Aug 9, 2024 - Abstract #MDSCongress2024MDS_Congress_1423;
No abstract available Patient was monitored using STAT-ON
- 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, Sponsor: University of Texas Southwestern Medical Center
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, Sponsor: Martini Hospital Groningen
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
Inhaled levodopa in fluctuating Parkinson (B3) - Jul 2, 2024 - Abstract #EAN2024EAN_2579;
Recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 In our cohort, inhaled levodopa provided rapid and substantial improvement in our cohort and was overall well tolerated with a discontinuation rate of 11%.
- || 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, Sponsor: Martini Hospital Groningen
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.
- imatinib (AER-901) / Aerami Therap
uniPHied: A Novel Platform Study Design for a Phase 2 Clinical Trial to Assess the Safety and Efficacy of AER-901 in Pulmonary Hypertension Associated With Interstitial Lung Disease and Pulmonary Arterial Hypertension (San Diego Convention Center, Area A (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_3925;
The unique platform design of uniPHied allows for expeditious evaluation of AER-901 in multiple pulmonary hypertension cohorts (PH-ILD and PAH) using smaller patient numbers. Each cohort is individually powered for the primary endpoint, allowing addition of cohorts for expansion to other pulmonary hypertension groups.
- imatinib (AER-901) / Aerami Therap
Functional Respiratory Imaging and Rapid Deposition Analysis Predict Enhanced Lung Deposition of Imatinib With the AER-901 Inhalation System in Pulmonary Hypertension (San Diego Convention Center, Area F (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_1711;
At equivalent nominal doses, FRI/RDA demonstrated enhanced deposition of imatinib throughout all regions of the lung for AER-901 compared with DPI-imatinib, suggesting that the AER-901 Inhalation System is more efficient than a DPI at delivering imatinib. These findings were consistent across all populations evaluated.
- Inbrija (levodopa inhalation powder) / Acorda
Novel In-Clinic Use of Levodopa Inhalation Powder (CVT-301) as a Outpatient Diagnostic Tool for Parkinson's Disease. (Poster hall) - Jan 30, 2024 - Abstract #MDSPAS2024MDS_PAS_92;
- Inbrija (levodopa inhalation powder) / Acorda
1101 Advanced Therapies in Parkinson () - Jan 30, 2024 - Abstract #MDSPAS2024MDS_PAS_1;
These findings were consistent across all populations evaluated. 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, Sponsor: University of Texas Southwestern Medical Center
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
Trial completion: A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops (clinicaltrials.gov) - Oct 27, 2023
P1, N=26, Completed, Sponsor: PureIMS B.V.
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Completed
- | 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, Sponsor: Martini Hospital Groningen
Active, not recruiting --> Completed Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Nov 2024
- || Levodopa Cyclops / PUREIMS
Enrollment closed: A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops (clinicaltrials.gov) - Sep 30, 2023
P1, N=26, Active, not recruiting, Sponsor: PureIMS B.V.
Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Nov 2024 Not yet recruiting --> Active, not recruiting
- | Levodopa Cyclops / PUREIMS
New P1 trial: A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops (clinicaltrials.gov) - Sep 14, 2023
P1, N=26, Not yet recruiting, Sponsor: PureIMS B.V.
- imatinib (AER-901) / Aerami Therap
LOW SYSTEMIC EXPOSURE AND MINIMAL ACCUMULATION PREDICTED WITH TWICE-DAILY ADMINISTRATION OF AER-901 (INHALED IMATINIB) AT POTENTIAL THERAPEUTIC DOSES (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_4146;
- || 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.
- imatinib (AER-901) / Aerami Therap
Low Systemic Exposure With Targeted Administration of AER-901 (Inhaled Imatinib): Results of a Phase 1 Clinical Trial (Brown 3) - Jun 17, 2023 - Abstract #ERS2023ERS_3068;
In this review, we explore those nuances to allow clinicians to select the best option for their patients. Epidemiology; Cell and molecular biology; Imaging
- || 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.
- imatinib (AER-901) / Aerami Therap
Pharmacokinetic Profile of Imatinib Mesylate Formulation (AER-901) Demonstrates Potential for Therapeutic Exposure Levels at Low Doses After Pulmonary Administration (Walter E. Washington Convention Center, Room 151 B (Street Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_3362;
The pharmacokinetic profile of AER-901 in rats demonstrated nearly 10-fold higher lung exposure compared with the same oral dose, suggesting that in the clinic, lower doses of the inhaled formulation of imatinib may achieve sufficient exposure in the lung. AER-901 is currently being evaluated in a phase 1 clinical study at inhaled doses approximately 5- to 80-fold lower than the oral imatinib doses investigated in the IMPRES trial.
- | Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Jan 18, 2023
P=N/A, N=120, Recruiting, Sponsor: University of Texas Southwestern Medical Center
AER-901 is currently being evaluated in a phase 1 clinical study at inhaled doses approximately 5- to 80-fold lower than the oral imatinib doses investigated in the IMPRES trial. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| imatinib (AER-901) / Aerami Therap
Trial completion: Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - Dec 7, 2022
P1, N=83, Completed, Sponsor: Aerami Therapeutics
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Recruiting --> Completed
- | 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, Sponsor: Martini Hospital Groningen
- | Enrollment open, Trial completion date, Trial primary completion date, Surgery: Motor Network Physiology (clinicaltrials.gov) - Mar 2, 2022
P=N/A, N=120, Recruiting, Sponsor: University of Texas Southwestern Medical Center
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
- || imatinib (AER-901) / Aerami Therap
Trial completion date, Trial primary completion date: Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - Feb 16, 2022
P1, N=78, Recruiting, Sponsor: Aerami Therapeutics
Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Aug 2022 --> Dec 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- | New trial, Surgery: Motor Network Physiology (clinicaltrials.gov) - Jul 12, 2021
P, N=120, Not yet recruiting, Sponsor: University of Texas Southwestern Medical Center
- | imatinib (AER-901) / Aerami Therap
New P1 trial: Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - May 25, 2021
P1, N=78, Recruiting, Sponsor: Aerami Therapeutics
- | Inbrija (levodopa inhalation powder) / Acorda
Trial completion: Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) (clinicaltrials.gov) - Aug 1, 2019
P1, N=23, Completed, Sponsor: Acorda Therapeutics
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Recruiting --> Completed
- || Inbrija (levodopa inhalation powder) / Acorda
New P1 trial: Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) (clinicaltrials.gov) - Mar 25, 2019
P1, N=24, Recruiting, Sponsor: Acorda Therapeutics
- | Inbrija (levodopa inhalation powder) / Merz Pharma
Phase classification: Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes (clinicaltrials.gov) - Aug 7, 2018
P2b, N=89, Completed, Sponsor: Acorda Therapeutics
Recruiting --> Completed Phase classification: P2 --> P2b
- ||||||| Inbrija (levodopa inhalation powder) / Merz Pharma
Trial completion: Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (clinicaltrials.gov) - Jun 1, 2018
P3, N=325, Completed, Sponsor: Acorda Therapeutics
Phase classification: P2 --> P2b Active, not recruiting --> Completed
- ||||| Inbrija (levodopa inhalation powder) / Acorda
Enrollment closed: Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (clinicaltrials.gov) - Jul 2, 2017
P3, N=325, Active, not recruiting, Sponsor: Acorda Therapeutics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||||| Inbrija (levodopa inhalation powder) / Acorda
Trial completion: Randomized Safety Study of CVT-301 Compared to an Observational Control Group (clinicaltrials.gov) - May 30, 2017
P3, N=408, Completed, Sponsor: Acorda Therapeutics
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Inbrija (levodopa inhalation powder) / Acorda
Trial completion: A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) (clinicaltrials.gov) - Jan 30, 2017
P1, N=36, Completed, Sponsor: Acorda Therapeutics
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Inbrija (levodopa inhalation powder) / Acorda
Trial primary completion date: Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (clinicaltrials.gov) - Jan 26, 2017
P3, N=350, Recruiting, Sponsor: Acorda Therapeutics
Active, not recruiting --> Completed Trial primary completion date: Dec 2017 --> Jun 2018
- ||||||| Inbrija (levodopa inhalation powder) / Acorda
Trial completion: SPAN-PD (clinicaltrials.gov) - Jan 26, 2017
P3, N=351, Completed, Sponsor: Acorda Therapeutics
Trial primary completion date: Dec 2017 --> Jun 2018 Active, not recruiting --> Completed
- |||| Inbrija (levodopa inhalation powder) / Acorda
Trial primary completion date: Randomized Safety Study of CVT-301 Compared to an Observational Control Group (clinicaltrials.gov) - Jan 26, 2017
P3, N=365, Active, not recruiting, Sponsor: Acorda Therapeutics
Active, not recruiting --> Completed Trial primary completion date: Dec 2016 --> May 2017
- Inbrija (levodopa inhalation powder) / Acorda
Enrollment closed: A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) (clinicaltrials.gov) - Dec 15, 2016
P1, N=36, Active, not recruiting, Sponsor: Acorda Therapeutics
Trial primary completion date: Dec 2016 --> May 2017 Recruiting --> Active, not recruiting
- | Inbrija (levodopa inhalation powder) / Acorda
Trial completion: A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet (clinicaltrials.gov) - Oct 11, 2016
P1, N=24, Completed, Sponsor: Acorda Therapeutics
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| Inbrija (levodopa inhalation powder) / Acorda
Enrollment closed: SPAN-PD (clinicaltrials.gov) - Aug 29, 2016
P3, N=345, Active, not recruiting, Sponsor: Acorda Therapeutics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- Inbrija (levodopa inhalation powder) / Acorda
Enrollment closed: A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet (clinicaltrials.gov) - Aug 15, 2016
P1, N=24, Active, not recruiting, Sponsor: Acorda Therapeutics
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||| Inbrija (levodopa inhalation powder) / Acorda
Trial primary completion date: SPAN-PD (clinicaltrials.gov) - Jul 19, 2016
P3, N=345, Recruiting, Sponsor: Acorda Therapeutics
Recruiting --> Active, not recruiting Trial primary completion date: Jun 2016 --> Dec 2016
- ||| Inbrija (levodopa inhalation powder) / Acorda
Trial completion: A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults (clinicaltrials.gov) - Jul 14, 2016
P1, N=60, Completed, Sponsor: Acorda Therapeutics
Trial primary completion date: Jun 2016 --> Dec 2016 Active, not recruiting --> Completed
- | Inbrija (levodopa inhalation powder) / Acorda
New P1 trial: A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet (clinicaltrials.gov) - Jun 24, 2016
P1, N=24, Recruiting, Sponsor: Acorda Therapeutics