6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 174 | Phase 3 | United States;Australia |
| 2 | EUCTR2018-004156-37-PT (EUCTR) | 16/06/2020 | 09/12/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;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 | ||
| 3 | EUCTR2018-004156-37-NL (EUCTR) | 14/06/2020 | 13/01/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 4 | EUCTR2018-004156-37-SE (EUCTR) | 18/05/2020 | 10/09/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | United 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 | ||
| 5 | EUCTR2018-004156-37-IT (EUCTR) | 04/05/2020 | 17/06/2021 | A 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] | Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP Product Code: [NA] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: [ND0612] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 6 | EUCTR2018-004156-37-SK (EUCTR) | 30/04/2020 | 13/02/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 7 | EUCTR2018-004156-37-BE (EUCTR) | 27/04/2020 | 03/03/2020 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 8 | EUCTR2018-004156-37-AT (EUCTR) | 02/03/2020 | 05/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 9 | EUCTR2018-004156-37-ES (EUCTR) | 11/02/2020 | 06/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;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 | ||
| 10 | EUCTR2018-004156-37-GB (EUCTR) | 14/01/2020 | 13/09/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;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 | ||
| 11 | EUCTR2018-004156-37-HU (EUCTR) | 19/12/2019 | 18/10/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;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 | ||
| 12 | EUCTR2018-004156-37-CZ (EUCTR) | 26/11/2019 | 26/09/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 13 | NCT04006210 (ClinicalTrials.gov) | August 27, 2019 | 30/6/2019 | A 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 Disease | Combination 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/100mg | NeuroDerm Ltd. | NULL | Recruiting | 30 Years | 80 Years | All | 380 | Phase 3 | United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| 14 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 15 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | 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] | 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 | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 16 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | 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 - 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. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 17 | NCT02604914 (ClinicalTrials.gov) | May 2015 | 3/11/2015 | A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects | 1) 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 Gel | Parkinson's Disease | Drug: ND0612;Drug: LCIG | NeuroDerm Ltd. | Quotient Clinical | Completed | 30 Years | 65 Years | All | 36 | Phase 1 | United Kingdom |
| 18 | NCT02763137 (ClinicalTrials.gov) | January 2015 | 26/4/2016 | Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients | A Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor Fluctuations | Parkinson Disease | Drug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CD | IRCCS San Raffaele | SynAgile Corporation | Completed | 35 Years | 75 Years | Both | 18 | Phase 2 | Italy |
| 19 | NCT02096601 (ClinicalTrials.gov) | August 2014 | 18/3/2014 | A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients | A 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 LD | Parkinson's Disease | Drug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopa | NeuroDerm Ltd. | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 16 | Phase 1/Phase 2 | United States;Israel |
| 20 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany |