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- carbidopa/levodopa / Generic mfg.
[VIRTUAL] Pharmacokinetic analysis of levodopa and carbidopa following subcutaneous infusion: A population pharmacokinetics model (Room Copenhagen) - May 30, 2021 - Abstract #EAN2021EAN_718;
Background and aims: ND0612 is an investigational subcutaneous delivery system providing minimally invasive, continuous infusion of liquid levodopa/carbidopa under development for reliable, sustained relief of motor fluctuations in people with Parkinson’s disease. Model diagnostics for the carbidopa and levodopa population PK models indicated a satisfactory predictive performance, supporting their usability to derive individual predictions of exposure to be used in future pharmacokinetic-pharmacodynamic analyses.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] Developing a drug-device combination for patients with Parkinson’s disease during the COVID19 pandemic (Room Lisbon) - May 30, 2021 - Abstract #EAN2021EAN_677;
The changes implemented were well-accepted by the investigators and patients and ensured patient safety while maintaining the clinical trial integrity. We found that clear and frequent communication, with a balanced ‘hybrid’ mix of virtual and in-person approaches, successfully enabled the safe continuation of pivotal clinical trials with this drug-device combination in patients with PD.
- carbidopa/levodopa / Generic mfg.
[VIRTUAL] Pharmacokinetic analysis of levodopa and carbidopa following subcutaneous infusion: A population pharmacokinetics model () - Mar 18, 2021 - Abstract #AAN2021AAN_1413;
Objective: To describe the population pharmacokinetics (PK) of levodopa and carbidopa following subcutaneous (SC) infusion with ND0612, with and without oral therapy, including associated interindividual variability and residual unexplained variability. Model diagnostics for the carbidopa and levodopa population PK models indicated a satisfactory predictive performance, supporting their usability to derive individual predictions of exposure to be used in future pharmacokinetic-pharmacodynamic analyses.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] Developing a drug-device combination for patients with Parkinson’s disease during the COVID19 pandemic () - Mar 18, 2021 - Abstract #AAN2021AAN_1366;
The changes implemented were well-accepted by the investigators and patients and ensured patient safety while maintaining the integrity of this clinical trial. We found that clear and frequent communication, with a balanced ‘hybrid’ mix of virtual and in-person approaches, successfully enabled the safe continuation of pivotal clinical trials with this drug-device combination in patients with PD.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] FIRST RESULTS FROM AN OPEN-LABEL STUDY EVALUATING LONG-TERM SAFETY OF ND0612 IN PD PATIENTS EXPERIENCING MOTOR FLUCTUATIONS () - Dec 24, 2020 - Abstract #ADPD2021ADPD_1381;
P2
No unanticipated systemic TEAEs for this patient population on levodopa treatment occurred. Long-term data will continue to be collected in patients enrolled in the study extension, some of whom are now in their fifth year of ND0612 treatment.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] Long term safety of levodopa/carbidopa infusion with ND0612: Results from a phase 2b, international, open-label study () - Sep 20, 2020 - Abstract #MDSCongress2020MDS Congress_941;
P2
Long-term data will continue to be collected in patients enrolled in the study extension, some of whom are now in their fourth year of ND0612 treatment. Partial data presented at EAN 2020 and AAN 2020.
- Comtan (entacapone) / Novartis, Orion, carbidopa/levodopa / Generic mfg.
[VIRTUAL] Population pharmacokinetic analysis of levodopa and carbidopa after subcutaneous administration with and without adjunct oral therapy () - Sep 20, 2020 - Abstract #MDSCongress2020MDS Congress_911;
P1, P3
Background: ND0612 is in development as the first drug-device combination delivering liquid LD/CD via continuous SC infusion to reduce motor complications in patients with Parkinson’s disease (PD)...Body weight was included as a structural predictor of the disposition parameters for both compounds based on allometry principles; entacapone coadministration was also a structural covariate on LD bioavailability which was increased under a combination treatment setting. Model diagnostics for the LD and CD population PK models indicated a satisfactory predictive performance, supporting their usability to derive individual predictions of exposure to be used in future PK-pharmacodynamic analyses.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] BouNDless: An active-controlled, randomised, double-blind, double-dummy trial of continuous subcutaneous infusion of levodopa/carbidopa with ND0612 in patients with Parkinsons disease experiencing motor complications (ePoster) - May 17, 2020 - Abstract #EAN2020EAN_3400;
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] First results for the BeyoND study: A phase 2b, international, open-label study evaluating long-term safety of ND0612 in patients with Parkinson’s disease experiencing motor complications (Room Berlin) - Apr 9, 2020 - Abstract #EAN2020EAN_2403;
P2
ND0612 infusion was found to be safe with generally mild to moderate local AEs which were reversible and manageable and no unexpected TEAEs for systemic levodopa treatment. Long-term data will continue to be collected in patients enrolled in the study extension, some of whom are now in their fourth year of ND0612 treatment.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] BouNDless: An active-controlled, randomised, double-blind, double-dummy trial of continuous subcutaneous infusion of levodopa/carbidopa with ND0612 in patients with Parkinson’s disease experiencing motor complications (Room: Screen A7) - Apr 9, 2020 - Abstract #EAN2020EAN_1987;
P3
Long-term data will continue to be collected in patients enrolled in the study extension, some of whom are now in their fourth year of ND0612 treatment. BouNDless will be the 1st phase 3 randomized, active-controlled trial to evaluate the efficacy and safety of continuous subcutaneous levodopa/carbidopa delivery with ND0612 compared to oral immediate-release levodopa/ carbidopa in patients with PD experiencing motor fluctuations.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] Pharmacokinetics of ND0612 administered at different infusion sites and with different cannula lengths: an open-label, randomised, cross-over study in healthy volunteers (ePoster) - Apr 9, 2020 - Abstract #EAN2020EAN_583;
There were no differences in the rate or extent of absorption of levodopa or carbidopa independent of infusion site location or cannula length. Furthermore, infusion to the back and outer thighs did not affect the safety of ND0612, offering patients alternative infusion locations for long-term ND0612 use.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
Pharmacokinetics of ND0612 Administered at Different Infusion Sites and with Different Cannula Lengths: An Open-Label, Randomized, Cross-Over Study in Healthy Volunteers (Biscayne Ballroom) - Feb 13, 2020 - Abstract #MDSPAS2020MDS_PAS_69;
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
BouNDless: An Active-Controlled Randomized, Double-Blind Double-Dummy Trial of Continuous Levodopa Delivery (ND0612) in Patients with Parkinson’s Disease Experiencing Motor Fluctuations (Biscayne Ballroom) - Feb 13, 2020 - Abstract #MDSPAS2020MDS_PAS_58;
Furthermore, infusion to the back and outer thighs did not affect the safety of ND0612, offering patients alternative infusion locations for long-term ND0612 use. BouNDless will be the first Phase III randomized, active-controlled trial to evaluate the efficacy and safety of continuous subcutaneous ND0612 compared to oral immediate-release LD/CD in patients with PD experiencing motor fluctuations.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
Impact of Subcutaneous Levodopa Infusion with ND0612 on Patient Reported Outcomes () - Feb 3, 2020 - Abstract #AAN2020AAN_5171;
BouNDless will be the first Phase III randomized, active-controlled trial to evaluate the efficacy and safety of continuous subcutaneous ND0612 compared to oral immediate-release LD/CD in patients with PD experiencing motor fluctuations. 24-hour levodopa infusion with ND0612 significantly improved patient ratings of ADL, QoL and overall clinical status.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
The BouNDless Study: An Active-Controlled, Randomized, Double-Blind, Double-Dummy Phase 3 Study of Continuous ND0612 Infusion in Patients with Parkinson’s Disease Experiencing Motor Fluctuations () - Feb 3, 2020 - Abstract #AAN2020AAN_5118;
P3
However, poor levodopa solubility has, until now, precluded this approach. BouNDless is the first phase 3 randomized, active-controlled trial designed to evaluate the efficacy and safety of treatment with continuous subcutaneous ND0612 in comparison to oral immediate-release LD/CD in patients with PD experiencing motor fluctuations.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
First Results for The BeyoND Study: An open-label international, multicenter study evaluating the long-term safety of ND0612 in patients with idiopathic Parkinson’s disease () - Feb 3, 2020 - Abstract #AAN2020AAN_4927;
P2
Systemic TEAEs were consistent with those expected for levodopa. Local infusion site reactions were manageable.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
First Results for The BeyoND Study: An open-label international, multicenter study evaluating the long-term safety of ND0612 in patients with idiopathic Parkinson’s disease () - Jan 21, 2020 - Abstract #AAN2020AAN_3246;
P2
Systemic TEAEs were consistent with those expected for levodopa. Local infusion site reactions were manageable.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
Impact of Subcutaneous Levodopa Infusion with ND0612 on Patient Reported Outcomes () - Jan 21, 2020 - Abstract #AAN2020AAN_56;
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] BOUNDLESS: AN ACTIVE-CONTROLLED RANDOMIZED, DOUBLE-BLIND DOUBLE-DUMMY TRIAL OF CONTINUOUS LEVODOPA DELIVERY (ND0612) IN PATIENTS WITH PARKINSON’S DISEASE EXPERIENCING MOTOR FLUCTUATIONS. (EXHIBITION HALL) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_430;
P3
Safety and tolerability will be assessed via adverse event reporting, including local skin safety assessments, rates of premature discontinuation, and treatment compliance. Conclusions BouNDless will be the first phase III randomized, active-controlled trial to evaluate the efficacy and safety of continuous subcutaneous ND0612 compared to oral immediate-release levodopa/carbidopa in patients with PD experiencing motor fluctuations.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
[VIRTUAL] PHARMACOKINETICS OF ND0612 ADMINISTERED AT DIFFERENT INFUSION SITES AND WITH DIFFERENT CANNULA LENGTHS: AN OPEN-LABEL, RANDOMIZED, CROSS-OVER STUDY IN HEALTHY VOLUNTEERS (EXHIBITION HALL) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_429;
Conclusions This Phase 1 study confirms that both the rate and extent of absorption of ND0612 are similar when administered using different injection site locations and cannula lengths. Infusion to back and outer thigh is not expected to affect efficacy of levodopa, offering alternative infusion locations for long-term ND0612 use.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial withdrawal: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations (clinicaltrials.gov) - Dec 10, 2019
P3, N=0, Withdrawn, Sponsor: NeuroDerm Ltd.
Infusion to back and outer thigh is not expected to affect efficacy of levodopa, offering alternative infusion locations for long-term ND0612 use. Terminated --> Withdrawn
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
BouNDless: An active-controlled randomized, double-blind double-dummy study of continuous ND0612 infusion in patients with fluctuating Parkinson’s disease (Agora 3 West, Level 3) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_559;
Terminated --> Withdrawn BouNDless will be the first Phase III randomized, active-controlled trial to establish the efficacy and safety of maintenance treatment with continuous subcutaneous ND0612 in comparison to oral immediate-release CD/LD in patients with PD experiencing motor fluctuations.
- levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe
Impact of ND0612 on patient reported outcomes: A blinded rater study of 2 dosing regimens (Agora 3 West, Level 3) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_487;
BouNDless will be the first Phase III randomized, active-controlled trial to establish the efficacy and safety of maintenance treatment with continuous subcutaneous ND0612 in comparison to oral immediate-release CD/LD in patients with PD experiencing motor fluctuations. 24-hour levodopa infusion with ND0612 significantly improved patient ratings of ADL, QoL and overall clinical status.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations (clinicaltrials.gov) - Nov 23, 2018
P3, N=1, Terminated, Sponsor: NeuroDerm Ltd.
24-hour levodopa infusion with ND0612 significantly improved patient ratings of ADL, QoL and overall clinical status. N=150 --> 1 | Trial completion date: Nov 2017 --> Oct 2018 | Recruiting --> Terminated | Trial primary completion date: Aug 2017 --> Oct 2018; Decision to change the study design
- |||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open, Enrollment change: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations (clinicaltrials.gov) - Sep 21, 2016
P3, N=150, Recruiting, Sponsor: NeuroDerm Ltd.
N=150 --> 1 | Trial completion date: Nov 2017 --> Oct 2018 | Recruiting --> Terminated | Trial primary completion date: Aug 2017 --> Oct 2018; Decision to change the study design Not yet recruiting --> Recruiting | N=240 --> 150
- ||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment change: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations (clinicaltrials.gov) - Jun 23, 2016
P3, N=240, Not yet recruiting, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Recruiting | N=240 --> 150 N=150 --> 240
- | levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe, levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Clinical: A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects (clinicaltrials.gov) - May 25, 2016
P1, N=36, Completed, Sponsor: NeuroDerm Ltd.
N=150 --> 240 Recruiting --> Completed | N=24 --> 36
- |||||||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P3 trial: A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations (clinicaltrials.gov) - May 25, 2016
P3, N=150, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- | levodopa/carbidopa low dose (ND0612L) / Mitsubishi Tanabe, levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Clinical: A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects (clinicaltrials.gov) - Nov 16, 2015
P1, N=24, Recruiting, Sponsor: NeuroDerm Ltd.