- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01100073
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
14. marts 2014 opdateret af: Boehringer Ingelheim
The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1703
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Krasnodar, Den Russiske Føderation
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Krasnoyarsk, Den Russiske Føderation
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Moscow, Den Russiske Føderation
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Moscow, Den Russiske Føderation
- Boehringer Ingelheim Investigational Site 126
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Moscow, Den Russiske Føderation
- Boehringer Ingelheim Investigational Site 127
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Novosibirsk, Den Russiske Føderation
- Boehringer Ingelheim Investigational Site 128
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Saint-Petersburg, Den Russiske Føderation
- Boehringer Ingelheim Investigational Site 132
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Saint-Petersburg, Den Russiske Føderation
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Saint-Petersburg, Den Russiske Føderation
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Tomsk, Den Russiske Føderation
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Keila, Estland
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Kohtla-Järve, Estland
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Tallinn, Estland
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Bacau, Rumænien
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Braila, Rumænien
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Caracal, Rumænien
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Constanta, Rumænien
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Constanta, Rumænien
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Craiova, Rumænien
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Craiova, Rumænien
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Craiova, Rumænien
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Deva, Rumænien
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Focsani, Rumænien
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Galati, Rumænien
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Galati, Rumænien
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Hunedoara, Rumænien
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Hunedoara, Rumænien
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Iasi, Rumænien
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Lugoj, Rumænien
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Maramures, Rumænien
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Orastie, Rumænien
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Pascani, Rumænien
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Pascani, Rumænien
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Petrosani, Rumænien
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Piatra Neamt, Rumænien
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Prahova, Rumænien
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Prahova, Rumænien
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Prahova, Rumænien
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Radauti, Rumænien
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Resita, Rumænien
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Satu Mare, Rumænien
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Sibiu, Rumænien
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Sibiu, Rumænien
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Slatina, Rumænien
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Suceava, Rumænien
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Suceava, Rumænien
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Teleorman, Rumænien
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Tg. Mures, Rumænien
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Timisoara, Rumænien
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Timisoara, Rumænien
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Timisoara, Rumænien
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Timisoara, Rumænien
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Tulcea, Rumænien
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Tulcea, Rumænien
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Belgrade, Serbien
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Kragujevac, Serbien
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Krusevac, Serbien
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Nis, Serbien
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Nis, Serbien
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Novi Sad, Serbien
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Sombor, Serbien
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Uzice, Serbien
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Valjevo, Serbien
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Vranje, Serbien
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Banská Bystrica, Slovakiet
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Bardejov, Slovakiet
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Bratislava, Slovakiet
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Bratislava, Slovakiet
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Bratislava, Slovakiet
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Bratislava, Slovakiet
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Bratislava, Slovakiet
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Bratislava, Slovakiet
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Brezno, Slovakiet
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Humenné, Slovakiet
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Ilava, Slovakiet
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Komárno, Slovakiet
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Kosice, Slovakiet
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Kosice, Slovakiet
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Kosice, Slovakiet
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Kosice, Slovakiet
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Kosice- Saca, Slovakiet
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Krompachy, Slovakiet
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Levice, Slovakiet
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Liptovský Mikulás, Slovakiet
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Lucenec, Slovakiet
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Martin, Slovakiet
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Nitra, Slovakiet
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Nitra, Slovakiet
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Nitra, Slovakiet
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Nováky, Slovakiet
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Nové Mesto n/ Váhom, Slovakiet
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Pezinok, Slovakiet
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Pies?any, Slovakiet
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Povazská Bystrica, Slovakiet
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Presov, Slovakiet
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Presov, Slovakiet
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Presov, Slovakiet
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Revúca, Slovakiet
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Rimavská Sobota, Slovakiet
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Roznava, Slovakiet
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Roznava, Slovakiet
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Sal'a, Slovakiet
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Sered, Slovakiet
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Trebisov, Slovakiet
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Trnava, Slovakiet
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Trstená, Slovakiet
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Vel'ke Kapusany, Slovakiet
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Neurologists
Beskrivelse
Inclusion Criteria:
- Idiopathic Parkinson's disease with or without fluctuations
- Indication for treatment with pramipexole (Mirapexin®)
- Presence of at least mild tremor symptoms (as judged by the treating physician)
Exclusion Criteria:
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with pramipexole (Mirapexin®)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Patients with Parkinson's disease
Early and advanced Parkinson's disease patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
Tidsramme: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study.
Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
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Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in UPDRS Part III Score at the End of Maintenance
Tidsramme: Week 0 to weeks 9-16
|
Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study.
Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
|
Week 0 to weeks 9-16
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Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
Tidsramme: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in tremor amplitude from baseline to end of study for the right hand
|
Week 0 to weeks 9-16 (Visit 3)
|
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Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
Tidsramme: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in tremor amplitude from baseline to end of study for the left hand
|
Week 0 to weeks 9-16 (Visit 3)
|
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Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
Tidsramme: Week 0 to weeks 9-16 (Visit 3)
|
Change (reduction)in tremor score from baseline to end of study.
Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
|
Week 0 to weeks 9-16 (Visit 3)
|
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Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
Tidsramme: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study.
Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
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Week 0 to weeks 9-16 (Visit 3)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Final Dose Distribution
Tidsramme: Enter Week 0 to weeks 9-16 (Visit 3)
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Final Mirapexin® dose distribution at the end of study
|
Enter Week 0 to weeks 9-16 (Visit 3)
|
|
Change From Baseline in UPDRS Part II Score at the End of Up-titration
Tidsramme: Enter Week 0 to weeks 1-8 (Visit 2)
|
Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
|
Enter Week 0 to weeks 1-8 (Visit 2)
|
|
Change From Baseline in UPDRS Part III Score at the End of Up-titration
Tidsramme: Enter Week 0 to weeks 1-8 (Visit 2)
|
Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
|
Enter Week 0 to weeks 1-8 (Visit 2)
|
|
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
Tidsramme: Enter Week 0 to weeks 1-8 (Visit 2)
|
Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
|
Enter Week 0 to weeks 1-8 (Visit 2)
|
|
Incidence, Relationship and Seriousness of Adverse Events
Tidsramme: Week 0 to weeks 9-16 (end of study)
|
Total number of adverse events (AEs), causality and level of seriousness
|
Week 0 to weeks 9-16 (end of study)
|
|
Number of Premature Discontinuations
Tidsramme: Week 0 to weeks 9-16 (end of study)
|
Number of patients discontinuing the study prematurely
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Week 0 to weeks 9-16 (end of study)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2008
Primær færdiggørelse (Faktiske)
1. august 2009
Datoer for studieregistrering
Først indsendt
18. marts 2010
Først indsendt, der opfyldte QC-kriterier
7. april 2010
Først opslået (Skøn)
8. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 248.657
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Mayo ClinicAfsluttet
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Bezmialem Vakif UniversityRekrutteringParkinsons sygdom | Parkinson | Parkinsons sygdom (PD) | PARKINSON SYGGE (lidelse) | Parkinsons sygdomTyrkiet (Türkiye)
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CND Life SciencesOregon Health and Science UniversityRekrutteringParkinsons sygdom | Parkinson | Parkinsons sygdom og Parkinsonisme | PARKINSON SYGGE (lidelse)Forenede Stater
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AstraZenecaParexelRekrutteringAvancerede solide tumorerSpanien, Forenede Stater, Sydkorea, Det Forenede Kongerige