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Pramipexole dihydrochloride    (DrugBank: Pramipexole)

2 diseases
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis3
6Parkinson disease7

2. Amyotrophic lateral sclerosis    [ 508 clinical trials,   530 drugs,   (DrugBank: 146 drugs),   170 drug target genes,   221 drug target pathways]
Searched query = "Amyotrophic lateral sclerosis", "ALS"
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.
3 / 508 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT00600873
(ClinicalTrials.gov)		August 20075/1/2008R(+)PPX High Dose Treatment of ALSPharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six MonthsAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.NULLCompleted30 Years80 YearsBoth10Phase 1;Phase 2United States
2NCT00596115
(ClinicalTrials.gov)		October 20055/1/2008Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/DayOpen Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per DayAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of Pittsburgh;University of NebraskaTemporarily not available30 Years80 YearsBothN/ANULL
3NCT00140218
(ClinicalTrials.gov)		August 200530/8/2005R(+) Pramipexole in Early Amyotrophic Lateral SclerosisFutility Study of R(+) Pramipexole in Early Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: R(+) pramipexole dihydrochloride monohydrateBennett, James P., Jr., M.D., Ph.D.University of PittsburghCompleted21 Years85 YearsBoth30Phase 1;Phase 2United States

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.
7 / 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
1NCT04275492
(ClinicalTrials.gov)		July 24, 202018/11/2019Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsStudy on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsParkinson's DiseaseDrug: Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride);Drug: Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)First Affiliated Hospital of Zhejiang UniversityHongguan biological pharmaceutical co.Recruiting18 Years45 YearsAll60N/AChina
2EUCTR2017-001420-21-DE
(EUCTR)		18/06/201816/02/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early 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 Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE		Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		525Phase 3United States;France;Canada;Spain;Germany
3EUCTR2017-001420-21-ES
(EUCTR)		13/06/201815/03/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early 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 Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE		Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		525Phase 3United States;France;Canada;Spain;Germany
4EUCTR2012-000801-64-GB
(EUCTR)		09/02/201326/11/2012A study of the effects of medication on memory in Parkinson's DiseaseA 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 StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes		55Phase 4United Kingdom
5EUCTR2008-000400-81-DE
(EUCTR)		11/05/200929/01/2009A 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 DyskinesiaA 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.NULLNot RecruitingFemale: yes
Male: yes		50Portugal;Germany;Italy
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2008-000400-81-PT
(EUCTR)		03/04/200927/01/2009A 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 DyskinesiaA 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 BVNULLNot RecruitingFemale: yes
Male: yes		50Portugal;Germany;Italy
7EUCTR2008-004943-12-SK
(EUCTR)		24/11/200810/10/2008The 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 StudyThe 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		320Phase 2Slovakia

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