Mirapex ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 19 |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| 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 | EUCTR2012-000801-64-GB (EUCTR) | 09/02/2013 | 26/11/2012 | A study of the effects of medication on memory in Parkinson's Disease | A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease. - Medication and Memory in Parkinson’s Disease (MeMory PaD) | Idiopathic Parkinson's Disease MedDRA version: 17.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mirapexin extended release various strengths Product Name: Pramipexole dihydrochloride monohydrate extended release Product Code: N/A INN or Proposed INN: pramipexole dihydrochloride monohydrate Other descriptive name: Mirapexin Trade Name: Requip prolonged release Product Name: Ropinirole hydrochloride prolonged release INN or Proposed INN: Ropinirole (as hydrochloride) Other descriptive name: Requip XL prolonged-release | University Hospital of North Staffordshire | Keele University | Not Recruiting | Female: yes Male: yes | 55 | Phase 4 | United Kingdom | ||
| 2 | NCT01525641 (ClinicalTrials.gov) | February 2012 | 1/2/2012 | Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Special Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease | Parkinson Disease | Drug: Mirapex LA | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 615 | N/A | Japan |
| 3 | JPRN-UMIN000006521 | 2011/10/01 | 11/10/2011 | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole | Parkinson's disease | Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks. | Department of Neurology, Juntendo University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 4 | NCT01515774 (ClinicalTrials.gov) | September 2011 | 10/1/2012 | Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) | An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease | Parkinson's Disease | Drug: Mirapex ER | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 200 | Phase 4 | Korea, Republic of |
| 5 | EUCTR2008-000400-81-DE (EUCTR) | 11/05/2009 | 29/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 6 | EUCTR2008-000400-81-PT (EUCTR) | 03/04/2009 | 27/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 7 | EUCTR2008-000400-81-IT (EUCTR) | 31/03/2009 | 17/04/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | Advanced Parkinson`s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 8 | EUCTR2009-015833-66-IT (EUCTR) | 20/01/2009 | 18/04/2012 | Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release | Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REQUIP*28CPR 8MG R.P. INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: REQUIP*21CPR 5MG INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: MIRAPEXIN*30CPR 0,7MG INN or Proposed INN: PRAMIPEXOLE Other descriptive name: NA | CASA DI CURA PRIVATA S.RAFFAELE - PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 9 | EUCTR2008-004943-12-SK (EUCTR) | 24/11/2008 | 10/10/2008 | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | Early Stage Parkinson’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Slovakia | ||
| 10 | EUCTR2006-003732-30-IT (EUCTR) | 31/12/2007 | 13/02/2008 | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: lisuride TTS INN or Proposed INN: Lisuride Trade Name: mirapexin INN or Proposed INN: Pramipexole | NEUROBIOTEC GMBH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 11 | ChiCTR-TRC-07000027 | 2007-11-01 | 2007-11-09 | A randomized controlled clinical study of Pramipexole for Parkinson's disease | A randomized controlled clinical study of Pramipexole for Parkinson's disease | Primary Parkinson's disease | Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease; | First Affiliated Hospital of Xinjiang Medical University | NULL | Completed | 30 | 80 | Both | Group 1:45;Group 3:45;Group 2:45; | China | |
| 12 | NCT00399477 (ClinicalTrials.gov) | October 2006 | 10/11/2006 | A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease | Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) | Parkinson's Disease | Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip | Teva Neuroscience, Inc. | NULL | Completed | 30 Years | N/A | Both | 200 | Phase 4 | United States |
| 13 | EUCTR2005-004949-34-ES (EUCTR) | 29/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 14 | NCT00321854 (ClinicalTrials.gov) | May 2006 | 3/5/2006 | Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) | A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease. | Parkinson Disease | Drug: pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | 79 Years | All | 535 | Phase 4 | United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom |
| 15 | EUCTR2005-003788-22-ES (EUCTR) | 09/02/2006 | 28/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España S.A. | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 16 | NCT00275275 (ClinicalTrials.gov) | January 2006 | 9/1/2006 | Pramipexole Conversion to Ropinirole Controlled Release (CR) | An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Requip PR;Drug: Mirapex | Rajesh Pahwa, MD | GlaxoSmithKline | Completed | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 17 | NCT00144300 (ClinicalTrials.gov) | January 2005 | 2/9/2005 | Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients | A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | Parkinson Disease | Drug: Mirapex;Drug: Requip | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 246 | Phase 4 | United States |
| 18 | NCT00096720 (ClinicalTrials.gov) | February 2004 | 12/11/2004 | Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease | Investigating Effects of Short-term Treatment With Pramipexole or Levodopa on [123I]B-CIT and SPECT Imaging in Early Parkinson's | Parkinson Disease;Parkinsonian Syndrome | Drug: levodopa;Drug: Mirapex (pramipexole);Procedure: [123I]ß-CIT and SPECT imaging | Institute for Neurodegenerative Disorders | Boehringer Ingelheim;Department of Defense | Completed | 30 Years | N/A | Both | 112 | Phase 2 | United States |
| 19 | NCT02248168 (ClinicalTrials.gov) | March 2002 | 22/9/2014 | Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease | Mirapex PMS Study Final Report | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1449 | N/A | NULL |