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9 Diseases |  |
2 Trials |
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2 Trials |  |
40 News |  |
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Phase classification: A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (clinicaltrials.gov) - Apr 28, 2024
P1, N=16, Completed, Sponsor: NeuroDerm Ltd.
Phase classification: P1/2 --> P1
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Phase classification: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients (clinicaltrials.gov) - Apr 18, 2024
P1, N=8, Completed, Sponsor: NeuroDerm Ltd.
Phase classification: P1/2 --> P1 Phase classification: P1/2 --> P1
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Phase classification: A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (clinicaltrials.gov) - Jan 17, 2024
P2, N=30, Completed, Sponsor: NeuroDerm Ltd.
Phase classification: P1/2 --> P1 Phase classification: P2a --> P2
- ||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion date: BouNDless: Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (clinicaltrials.gov) - Nov 1, 2023
P3, N=381, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Phase classification: P2a --> P2 Trial completion date: Oct 2023 --> Feb 2027
- || levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion date, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - May 6, 2023
P2, N=214, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Trial completion date: Oct 2023 --> Feb 2027 Trial completion date: Oct 2023 --> Feb 2027
- ||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment closed: BouNDless: Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (clinicaltrials.gov) - May 24, 2022
P3, N=381, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Trial completion date: Oct 2023 --> Feb 2027 Recruiting --> Active, not recruiting
- |||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion date, Trial primary completion date: BouNDless: Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (clinicaltrials.gov) - Nov 10, 2020
P3, N=380, Recruiting, Sponsor: NeuroDerm Ltd.
Recruiting --> Active, not recruiting Trial completion date: Apr 2021 --> Oct 2023 | Trial primary completion date: Mar 2021 --> Jul 2022
- || levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion date, Trial primary completion date, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - May 5, 2020
P2, N=210, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Trial completion date: Apr 2021 --> Oct 2023 | Trial primary completion date: Mar 2021 --> Jul 2022 Trial completion date: Aug 2021 --> Oct 2023 | Trial primary completion date: Aug 2019 --> Sep 2023
- | 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.
Trial completion date: Aug 2021 --> Oct 2023 | Trial primary completion date: Aug 2019 --> Sep 2023 Terminated --> Withdrawn
- || levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion: A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (clinicaltrials.gov) - Dec 6, 2019
P1/2, N=16, Completed, Sponsor: NeuroDerm Ltd.
Terminated --> Withdrawn Not yet recruiting --> Completed
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open, Trial primary completion date: BouNDless: Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (clinicaltrials.gov) - Sep 25, 2019
P3, N=300, Recruiting, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Completed Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2020 --> Apr 2021
- levodopa/carbidopa SC (ABBV-951) / AbbVie
Lack of Notable Skin Reactions from a Novel Levodopa/Carbidopa Prodrug after 10 Days of Repeated 24-Hour Continuous Subcutaneous Infusion at the Same Administration Site (Agora 3 West, Level 3) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_695;
Dopaminergic therapies for CSCI are available (apomorphine) or in development (ND0612H); however, the onset of uncomfortable skin reactions, which might impact drug absorption and require daily rotation of infusion sets, might affect quality of life and limit their use. ABBV-951 was safe, well tolerated and did not cause notable skin reactions at low, yet clinically relevant doses, administered in the same skin area for 10 consecutive days.
- |||||||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P3 trial: BouNDless: Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (clinicaltrials.gov) - Jul 4, 2019
P3, N=300, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- || levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion, Metastases: ND0612H-006: A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (clinicaltrials.gov) - Apr 9, 2019
P2, N=38, Completed, Sponsor: NeuroDerm Ltd.
ABBV-951 was safe, well tolerated and did not cause notable skin reactions at low, yet clinically relevant doses, administered in the same skin area for 10 consecutive days. Active, not recruiting --> Completed
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment change, Trial withdrawal, Metastases: A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension (clinicaltrials.gov) - Nov 23, 2018
P3, N=0, Withdrawn, Sponsor: NeuroDerm Ltd.
Active, not recruiting --> Completed N=50 --> 0 | Not yet recruiting --> Withdrawn
- | 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.
N=50 --> 0 | Not yet recruiting --> Withdrawn 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 closed, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - Nov 21, 2018
P2, N=210, Active, not 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 Recruiting --> Active, not recruiting
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion date, Trial primary completion date, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - Sep 10, 2018
P2, N=210, Recruiting, Sponsor: NeuroDerm Ltd.
Recruiting --> Active, not recruiting Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Oct 2018 --> Aug 2019
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - Jul 24, 2018
P2, N=210, Recruiting, Sponsor: NeuroDerm Ltd.
Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Oct 2018 --> Aug 2019 Active, not recruiting --> Recruiting | N=100 --> 210 | Trial completion date: May 2018 --> Jun 2020 | Trial primary completion date: Feb 2018 --> Oct 2018
- ||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P3 trial, Metastases: A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension (clinicaltrials.gov) - Mar 11, 2018
P3, N=50, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- ||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment closed, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - Aug 30, 2017
P2, N=100, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Active, not recruiting --> Recruiting | N=100 --> 210 | Trial completion date: May 2018 --> Jun 2020 | Trial primary completion date: Feb 2018 --> Oct 2018 Recruiting --> Active, not recruiting
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment closed, Metastases: A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (clinicaltrials.gov) - Jan 5, 2017
P2, N=38, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||| 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.
Recruiting --> Active, not recruiting 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 high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - May 18, 2016
P2, N=100, Recruiting, Sponsor: NeuroDerm Ltd.
Recruiting --> Completed | N=24 --> 36 Not yet recruiting --> Recruiting
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion: A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (clinicaltrials.gov) - Apr 1, 2016
P2, N=30, Completed, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Recruiting Recruiting --> Completed
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients (clinicaltrials.gov) - Apr 1, 2016
P1/2, N=8, Completed, Sponsor: NeuroDerm Ltd.
Recruiting --> Completed Active, not recruiting --> Completed
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Trial completion, Trial primary completion date: Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers (clinicaltrials.gov) - Apr 1, 2016
P1, N=36, Completed, Sponsor: NeuroDerm Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Aug 2013 --> Oct 2012
- ||||| levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P2 trial, Metastases: BeyoND: A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease (clinicaltrials.gov) - Apr 1, 2016
P2, N=100, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open, Metastases: A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (clinicaltrials.gov) - Jan 15, 2016
P2, N=36, Recruiting, Sponsor: NeuroDerm Ltd.
Active, not recruiting --> Completed | Trial primary completion date: Aug 2013 --> Oct 2012 Not yet recruiting --> Recruiting
- | 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.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P2 trial, Metastases: A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (clinicaltrials.gov) - Oct 22, 2015
P2, N=36, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P1/2 trial: A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients (clinicaltrials.gov) - Mar 24, 2014
P1/2, N=0, Not yet recruiting, Sponsor: NeuroDerm Ltd.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment open: A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (clinicaltrials.gov) - Mar 17, 2014
P2, N=30, Recruiting, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P2 trial: A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 (clinicaltrials.gov) - Jun 19, 2013
P2, N=30, Recruiting, Sponsor: NeuroDerm Ltd.
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment closed: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients (clinicaltrials.gov) - Jun 5, 2013
P1/2, N=8, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
Enrollment closed: Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers (clinicaltrials.gov) - Jun 5, 2013
P1, N=36, Active, not recruiting, Sponsor: NeuroDerm Ltd.
Not yet recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P1/2 trial: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients (clinicaltrials.gov) - Nov 12, 2012
P1/2, N=8, Active, not recruiting, Sponsor: NeuroDerm Ltd.
- | levodopa/carbidopa high dose (ND0612H) / Mitsubishi Tanabe
New P1 trial: Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers (clinicaltrials.gov) - Dec 4, 2011
P1, N=36, Active, not recruiting, Sponsor: NeuroDerm Ltd.