 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
63 News |  |
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial completion date, Trial primary completion date: Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease (clinicaltrials.gov) - Jul 24, 2024
P2, N=132, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Sep 2025
- | Journal: Levodopa-induced dyskinesia: do current clinical trials hold hope for future treatment? (Pubmed Central) - Dec 20, 2023
Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Sep 2025 No abstract available
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial completion date, Trial primary completion date: Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease (clinicaltrials.gov) - Oct 23, 2023
P2, N=132, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
No abstract available Trial completion date: Nov 2024 --> Feb 2025 | Trial primary completion date: Nov 2024 --> Feb 2025
- |||| lenrispodun (ITI-214) - Intra / Cellular Therapies
New P2 trial: Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease (clinicaltrials.gov) - Mar 13, 2023
P2, N=132, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Journal: Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. (Pubmed Central) - Aug 17, 2022
P1
Future investigations should determine whether lenrispodun improves inhibitory control in target populations such as individuals with attention deficit hyperactivity disorder. Trial registration: ClinicalTrials.gov identifier: NCT03489772.
- lenrispodun (ITI-214) - Intra / Cellular Therapies
ITI-214, a potent and selective PDE1 inhibitor, inhibits tumor growth when combined with a checkpoint inhibitor in a mouse model of breast cancer (Section 21) - Mar 9, 2022 - Abstract #AACR2022AACR_4742;
In conclusion, this study demonstrates a synergistic ability of ITI-214 and anti-PD-1 to alter the tumor microenvironment and control tumor growth in mice. Translating these findings to the clinic suggests that ITI-214 may provide a means to expand the utility of immune checkpoint inhibitors to treatment-refractory tumors.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Journal: The Effects of Acute and Chronic Selective Phosphodiesterase 1 Inhibition on Smooth Muscle Cell-Associated Aging Features. (Pubmed Central) - Feb 19, 2022
Yet, after chronic treatment, the effects of PDE1 inhibition might be counteracted by the interplay between differential PDE1A and C expression. These results warrant further pharmacodynamic profiling of PDE enzyme regulation during chronic PDE1 inhibitor treatment.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Journal: Selective PDE1 inhibition ameliorates vascular function, reduces inflammatory response, and lowers blood pressure in ageing animals. (Pubmed Central) - Dec 25, 2021
In the present study, we studied the effect of acute and chronic treatment with ITI-214, a selective phosphodiesterase 1 inhibitor on vascular aging features in Ercc1 mice...These findings suggest PDE1 inhibition would provide a powerful tool for nitric oxide - cGMP augmentation and have significant therapeutic potential to battle arteriopathy related to ageing. Significance Statement The findings implicate the key role of PDE1 in vascular function and might be of clinical importance for prevention of mortalities and morbidities related to vascular complications during ageing, as well as for progeria patients that show a high risk of cardiovascular disease.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Journal: Acute Hemodynamic Effects and Tolerability of Phosphodiesterase-1 Inhibition With ITI-214 in Human Systolic Heart Failure. (Pubmed Central) - Dec 25, 2021
P1/2
Single-dose ITI-214 is well-tolerated and confers inodilator effects in humans with heart failure with reduced ejection fraction. Further investigations of its therapeutic utility are warranted.
- lenrispodun (ITI-214) - Intra / Cellular Therapies
Single Doses of a Highly Selective Inhibitor of Phosphodiesterase 1 (Lenrispodun) in Healthy Volunteers: A Randomized Pharmaco-fMRI Clinical Trial ([VIRTUAL]) - Nov 28, 2021 - Abstract #ACNP2021ACNP_859;
However, lenrispodun did not induce an attenuating effect on BOLD fMRI signals in the dAI during the extinction phase of a fear conditioning task. Collectively, these results support the hypothesis that PDE 1 inhibition affects neural inhibitory control.
- lenrispodun (ITI-214) - Intra / Cellular Therapies
[VIRTUAL] The Effects of Acute and Chronic Selective Phosphodiesterase 1 Inhibition in Associated Smooth Muscle Cell-Specific Aging Features (OnDemand) - Sep 24, 2021 - Abstract #AHA2021AHA_6677;
Yet, its chronic effects might be counteracted by the upregulation of PDE1a in vasculature. These results warrant further pharmacodynamic profiling of PDE enzyme regulation during chronic PDE1 inhibitor treatment.
- lenrispodun (ITI-214) - Intra / Cellular Therapies
[VIRTUAL] Effects of ITI-214, a potent and selective phosphodiesterase type 1 inhibitor, on tumor myeloid cellular composition, tumor volume and survival in mouse models of colorectal cancer when combined with an anti-PD-1 checkpoint inhibitor () - Mar 11, 2021 - Abstract #AACR2021AACR_449;
Together, these studies demonstrate a synergistic ability of ITI-214 and anti-PD-1 to alter the tumor environment and control tumor growth. Translating these findings to humans suggests that ITI-214 may provide a means to expand the utility of immune checkpoint inhibitors in immunogenic tumors.
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial completion, Trial completion date, Trial primary completion date: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure (clinicaltrials.gov) - Dec 24, 2020
P1/2, N=36, Completed, Sponsor: Intra-Cellular Therapies, Inc.
Translating these findings to humans suggests that ITI-214 may provide a means to expand the utility of immune checkpoint inhibitors in immunogenic tumors. Recruiting --> Completed | Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020
- | ITI-214 - Intra / Cellular Therapies, ITI / 214
Journal: Inhibition of calcium-calmodulin-dependent phosphodiesterase (PDE1) suppresses inflammatory responses. (Pubmed Central) - Nov 7, 2020
These studies are the first to demonstrate that inhibition of PDE1 exerts anti-inflammatory effects through effects on microglia signaling pathways. The ability of PDE1 inhibitors to prevent or dampen excessive inflammatory responses of BV2 cells and microglia provides a basis for exploring their therapeutic utility in the treatment of neurodegenerative diseases associated with increased inflammation and microglia proliferation such as Parkinson's disease and Alzheimer's disease.
- ITI-214 - Intra / Cellular Therapies
[VIRTUAL] Cardiac And Hemodynamic Effects Of Acute Phosphodiesterase-1 Inhibition In Human Heart Failure (Poster Hall - Moderated) - Sep 10, 2020 - Abstract #HFSA2020HFSA_125;
P1/2
These data confirm our previous findings in the canine HF model. Further investigation of acute and chronic PDE-1 inhibition in HF should be considered.
- ITI-214 - Intra / Cellular Therapies, ITI / 214
[VIRTUAL] Phosphodiesterase 1 Modulates Sarcolemmal CAMP to Increase the L-type Calcium Channel Activity and Induce Cardiomyocyte Contraction () - Jul 26, 2020 - Abstract #BCVS2020BCVS_313;
Finally, the effects of PDE1 inhibition on %SS and peak Ca2+ transients were reversed by the LTCC blocker nitrendipine. We propose a novel mechanism that PDE1 modulates sl cAMP to increase LTCC and to induce contractility.
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial completion: Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement (clinicaltrials.gov) - Nov 14, 2019
P1, N=26, Completed, Sponsor: Intra-Cellular Therapies, Inc.
We propose a novel mechanism that PDE1 modulates sl cAMP to increase LTCC and to induce contractility. Active, not recruiting --> Completed
- | ITI-214 - Intra / Cellular Therapies, ITI / 214
Journal: Targeting the Dopamine 1 Receptor or its Downstream Signalling by Inhibiting Phosphodiesterase-1 Improves Cognitive Performance. (Pubmed Central) - Oct 29, 2019
We hypothesise that PDE1 inhibition may improve working memory performance by increasing prefrontal synaptic transmission and/or postsynaptic D1 receptor signalling, by modulating prefrontal downstream second messenger levels. These data may therefore support the use of PDE1 inhibitors as a potential approach for the treatment of cognitive dysfunction.
- | Journal: Acute Enhancement of Cardiac Function by Phosphodiesterase Type 1 Inhibition: A Translational Study in the Dog and Rabbit. (Pubmed Central) - Oct 2, 2019
ITI-214 effects were additive to β-adrenergic receptor agonism (dobutamine)...In rabbits, β-adrenergic receptor blockade (esmolol) prevented ITI-214-mediated chronotropy, but inotropy and vasodilation remained unchanged...The effects appear related to cAMP signaling that is different from that provided via beta-AR receptors or PDE3 modulation. ITI-214, which has completed Phase I trials, may provide a novel therapy for HF.
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment closed: Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement (clinicaltrials.gov) - Jun 28, 2019
P1, N=26, Active, not recruiting, Sponsor: Intra-Cellular Therapies, Inc.
ITI-214, which has completed Phase I trials, may provide a novel therapy for HF. Recruiting --> Active, not recruiting
- || lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial completion: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease (clinicaltrials.gov) - Dec 20, 2018
P1/2, N=40, Completed, Sponsor: Intra-Cellular Therapies, Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial primary completion date: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease (clinicaltrials.gov) - Jul 26, 2018
P1/2, N=40, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
Recruiting --> Completed Trial primary completion date: May 2018 --> Aug 2018
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure (clinicaltrials.gov) - Jul 26, 2018
P1/2, N=36, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
Trial primary completion date: May 2018 --> Aug 2018 Not yet recruiting --> Recruiting | Trial completion date: Jul 2019 --> Dec 2019 | Initiation date: Jan 2018 --> Jul 2018 | Trial primary completion date: Jul 2019 --> Dec 2019
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment open: Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement (clinicaltrials.gov) - Jul 26, 2018
P1, N=25, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
Not yet recruiting --> Recruiting | Trial completion date: Jul 2019 --> Dec 2019 | Initiation date: Jan 2018 --> Jul 2018 | Trial primary completion date: Jul 2019 --> Dec 2019 Not yet recruiting --> Recruiting
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment change: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease (clinicaltrials.gov) - Apr 30, 2018
P1/2, N=32, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
Not yet recruiting --> Recruiting N=24 --> 32
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
New P1 trial: Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement (clinicaltrials.gov) - Apr 5, 2018
P1, N=25, Not yet recruiting, Sponsor: Intra-Cellular Therapies, Inc.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
New P1/2 trial: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure (clinicaltrials.gov) - Jan 2, 2018
P1/2, N=36, Not yet recruiting, Sponsor: Intra-Cellular Therapies, Inc.
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment open: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease (clinicaltrials.gov) - Sep 27, 2017
P1/2, N=24, Recruiting, Sponsor: Intra-Cellular Therapies, Inc.
N=24 --> 32 Not yet recruiting --> Recruiting
- | lenrispodun (ITI-214) - Intra / Cellular Therapies
New P1/2 trial: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease (clinicaltrials.gov) - Aug 21, 2017
P1/2, N=24, Not yet recruiting, Sponsor: Intra-Cellular Therapies, Inc.
- lenrispodun (ITI-214) - Intra / Cellular Therapies
Trial termination: Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia (clinicaltrials.gov) - Feb 19, 2015
P1, N=76, Terminated, Sponsor: Takeda
Not yet recruiting --> Recruiting Recruiting --> Terminated; Business Decision; No Safety or Efficacy Concerns
- ||| lenrispodun (ITI-214) - Intra / Cellular Therapies
Enrollment open: Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia (clinicaltrials.gov) - Feb 22, 2014
P1, N=64, Recruiting, Sponsor: Takeda
Recruiting --> Terminated; Business Decision; No Safety or Efficacy Concerns Not yet recruiting --> Recruiting
- ||| lenrispodun (ITI-214) - Intra / Cellular Therapies
New P1 trial: Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia (clinicaltrials.gov) - Jul 14, 2013
P1, N=64, Recruiting, Sponsor: Takeda