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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
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Demography Screening Ropinirole Parkinson Disease 101468/165 - Demography Screening

- 15.10.17 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Demography
Study Part: Demography Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

dbGaP phs000048 Mayo-Perlegen LEAPS (Linked Efforts to Accelerate Parkinson's Solutions) Collaboration - Eligibility

- 29.01.25 - 3 Formulare, 1 Itemgruppe, 2 Datenelemente, 1 Sprache
Itemgruppe: IG.elig
Principal Investigator: Demetrius M. Maraganore, Mayo Clinic, Rochester, MN, USA MeSH: Parkinson Disease https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000048 We performed a two-tiered, whole-genome association study of Parkinson disease (PD). For tier 1, we individually genotyped 198,345 uniformly spaced and informative single-nucleotide polymorphisms (SNPs) in 443 sibling pairs discordant for PD. For tier 2a, we individually genotyped 1,793 PD-associated SNPs (P.01 in tier 1) and 300 genomic control SNPs in 332 matched case-unrelated control pairs. We identified 11 SNPs that were associated with PD (P.01) in both tier 1 and tier 2 samples and had the same direction of effect. For these SNPs, we combined data from the case-unaffected sibling pair (tier 1) and case-unrelated control pair (tier 2) samples and employed a liberalization of the sibling transmission/disequilibrium test to calculate odds ratios, 95% confidence intervals, and P values. A SNP within the semaphorin 5A gene (SEMA5A) had the lowest combined P value (P=7.62E-6). The protein encoded by this gene plays an important role in neurogenesis and in neuronal apoptosis, which is consistent with existing hypotheses regarding PD pathogenesis. A second SNP tagged the PARK11 late-onset PD susceptibility locus (P=1.70E-5). In tier 2b, we also selected for genotyping additional SNPs that were borderline significant (P.05) in tier 1 but that tested a priori biological and genetic hypotheses regarding susceptibility to PD (n=941 SNPs). In analysis of the combined tier 1 and tier 2b data, the two SNPs with the lowest P values (P=9.07E-6; P=2.96E-5) tagged the PARK10 late-onset PD susceptibility locus. Independent replication across populations will clarify the role of the genomic loci tagged by these SNPs in conferring PD susceptibility. Note: The following instruments were used: 1)clinical assessments form and manual; 2) sibling screening form and manual; 3) unrelated control screening and manual; and 4) risk factors questionnaire and manual. All cases underwent #1, as did sibling controls screening positive (see below). Unrelated controls were not examined. All siblings underwent #2. All unrelated controls underwent #3. All subjects (cases, sibling controls, and unrelated controls) underwent #4. Any publications using the data are to cite the original American Journal of Human Genetics article (Maraganore et al., 2005). Investigators using the data collection instruments are to acknowledge Drs. Maraganore and Rocca, and cite grants ES-10751 and NS-33978.

pht000184.v1.p1

1 Itemgruppe 6 Datenelemente

pht000071.v1.p1

1 Itemgruppe 6 Datenelemente

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20.09.21 - 1 Formular, 18 Itemgruppen, 90 Datenelemente, 1 Sprache
Itemgruppen: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, Pregnancy test, Alcohol test, Urine drug screening, orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Randomization, High fat breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - post dosing, Pharmacokinetic sampling post dosing, Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20.09.21 - 1 Formular, 10 Itemgruppen, 61 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria, Demographics, Medical history, Parkinson's disease Surgical history, Allergies, Parkinson's disease history, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test
Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Eligibility Parkinson's Disease NCT00360412

- 20.09.21 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00360412

Eligibility Parkinson's Disease NCT00292227

- 20.09.21 - 1 Formular, 2 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00292227

visit 1 inclusion/exclusion criteria starting dose of ropinirole Parkinson's Disease 101468/166

- 20.09.21 - 1 Formular, 3 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: administrative data, Inclusion criteria, exclusion criteria
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Vital Signs Screening Ropinirole Parkinson Disease 101468/165 - Vital Signs Screening

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Vital Signs Week 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 3 (Visit 7)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 3 (Visit 7). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Vital Signs Week 2 PK Visit (Visit 6) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 2 PK Visit (Visit 6)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 2 PK Visit (Visit 6). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Vital Signs Week 1 Pre-dose (Visit 1)Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 Pre-dose (Visit 1)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 1 Pre-dose (Visit 1). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Vital Signs Week 1 Day 1 (Visit 2) Ropinirole Parkinson Disease 101468/165 - Vital Signs Week 1 Day 1 (Visit 2)

- 20.09.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Vital Signs
Study Part: Vital Signs Week 1 Day 1 (Visit 2). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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