Nd0612    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
6Parkinson disease37

6. Parkinson disease    [ 2,123 clinical trials,   2,046 drugs,   (DrugBank: 324 drugs),   183 drug target genes,   198 drug target pathways]
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
37 / 2,123 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004156-37-PT
(EUCTR)
16/06/202009/12/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD/CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
2EUCTR2018-004156-37-NL
(EUCTR)
14/06/202013/01/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of
3EUCTR2018-004156-37-SE
(EUCTR)
18/05/202010/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
4EUCTR2018-004156-37-SK
(EUCTR)
30/04/202013/02/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Levodopa/Carbidopa Solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
5EUCTR2018-004156-37-BE
(EUCTR)
27/04/202003/03/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004156-37-AT
(EUCTR)
02/03/202005/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
7EUCTR2018-004156-37-ES
(EUCTR)
11/02/202006/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
8EUCTR2018-004156-37-GB
(EUCTR)
14/01/202013/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
9EUCTR2018-004156-37-HU
(EUCTR)
19/12/201918/10/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
10EUCTR2018-004156-37-CZ
(EUCTR)
26/11/201926/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04006210
(ClinicalTrials.gov)
August 27, 201930/6/2019A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless).A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)Parkinson's DiseaseCombination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mgNeuroDerm Ltd.NULLRecruiting30 Years80 YearsAll380Phase 3United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Ukraine;United Kingdom
12EUCTR2016-002033-30-NL
(EUCTR)
31/10/201815/11/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
13EUCTR2017-002780-17-ES
(EUCTR)
21/05/201812/02/2018Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa.A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;United States;Spain;Austria;Netherlands;Italy
14EUCTR2017-002780-17-FR
(EUCTR)
26/04/201827/02/2018-A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
15EUCTR2017-002780-17-IT
(EUCTR)
10/04/201804/11/2020study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusionA Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered Parkinson¿s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
NEURODERM LTD.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-002033-30-GB
(EUCTR)
27/11/201705/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
17EUCTR2016-002033-30-HU
(EUCTR)
08/11/201719/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany
18EUCTR2015-005814-31-BE
(EUCTR)
06/07/201705/05/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
19EUCTR2015-005814-31-ES
(EUCTR)
22/06/201721/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
20EUCTR2015-005814-31-HU
(EUCTR)
14/06/201720/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-005814-31-PL
(EUCTR)
25/05/201714/02/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
22EUCTR2015-005814-31-CZ
(EUCTR)
03/03/201701/12/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
210Phase 2France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
23EUCTR2015-005814-31-DE
(EUCTR)
07/02/201724/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
24EUCTR2016-002033-30-BE
(EUCTR)
19/12/201621/11/2016A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
25EUCTR2016-002033-30-FR
(EUCTR)
29/11/201612/01/2017A 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 fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group 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 (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
150Phase 3United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-002033-30-ES
(EUCTR)
03/11/201625/08/2016A 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 fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group 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 (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden
27EUCTR2015-005078-39-DE
(EUCTR)
21/09/201602/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
28EUCTR2015-005814-31-AT
(EUCTR)
29/08/201611/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
29NCT02782481
(ClinicalTrials.gov)
August 201622/5/2016A 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 FluctuationsA Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group 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 FluctuationsParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLWithdrawn30 Years80 YearsAll0Phase 3Israel
30EUCTR2015-005078-39-AT
(EUCTR)
30/05/201609/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02726386
(ClinicalTrials.gov)
May 201629/3/2016A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC InfusionA Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612NeuroDerm Ltd.NULLActive, not recruiting30 YearsN/AAll210Phase 2United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
32NCT02577523
(ClinicalTrials.gov)
November 20156/10/2015A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseA Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612 (Levodopa/Carbidopa solution)NeuroDerm Ltd.NULLCompleted30 Years80 YearsAll38Phase 2United States;Austria;Israel;Italy
33NCT02604914
(ClinicalTrials.gov)
May 20153/11/2015A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal GelParkinson's DiseaseDrug: ND0612;Drug: LCIGNeuroDerm Ltd.Quotient ClinicalCompleted30 Years65 YearsAll36Phase 1United Kingdom
34NCT02096601
(ClinicalTrials.gov)
August 201418/3/2014A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease PatientsA Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LDParkinson's DiseaseDrug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopaNeuroDerm Ltd.Michael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll16Phase 1;Phase 2United States;Israel
35NCT01883505
(ClinicalTrials.gov)
December 20139/6/2013A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612Parkinson's DiseaseDrug: Levodopa and carbidopa;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth30Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01725802
(ClinicalTrials.gov)
December 20124/11/2012A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsA Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsParkinson's DiseaseDrug: levodopa and carbidopa solution for SC administration;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth8Phase 1;Phase 2Israel
37NCT01486628
(ClinicalTrials.gov)
April 20124/12/2011Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersA Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLCompleted18 Years40 YearsMale36Phase 1Israel