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Relevancia Evaluación Nuevo primero Antiguo primero

dbGaP phs001071 NINDS Family-Based Whole-Genome Sequencing to Find HD Modifiers - pht005344.v1.p1

- 23/06/2023 - 6 formularios, 1 itemgroup, 3 items, 1 idioma
Itemgroup: pht005344
Principal Investigator: Steven Finkbeiner, Gladstone Institutes, San Francesco, CA, USA MeSH: Huntington Disease,Degenerative Hereditary Diseases, Nervous System,Cell Death,Brain Diseases,Ataxia,Chorea,Cognition Disorders,Dyskinesias,Mental Disorders https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001071 The goal of our studies is to identify genetic modifiers of neurodegeneration in Huntington's disease (HD). HD is caused by expansion of CAG repeats in the huntingtin (Htt) gene, with longer stretches often leading to more rapid disease onset and progression. Yet, for a given number of repeats, the age of symptom onset can be variable, differing by up to decades. Thus, the age of onset of motor symptoms in HD is only partly explained by the length of the CAG expansion. Available evidence suggests that genetic modifiers contribute to the variation in HD onset. Identifying genetic modifiers is important because they may provide critical insights into HD pathogenesis and reveal key pathways that could be targeted by novel HD therapeutics. This is important since there are no disease-modifying therapies for HD, and mHtt is an unattractive small-molecule drug target. We recruited 21 HD families with varying characteristics of disease progression and age of onset and obtained medical histories, clinical records and DNA samples that were subjected to whole-genome sequencing (WGS). These WGS data describe families of 104 subjects, including HD patients and their unaffected family members. These individuals were selected based on individual clinical histories and family structures that best fit our criteria for expressing potential genetic modifiers. We are testing the hypothesis that novel, rare genetic variants contribute to HD and those genetic modifiers can be identified by WGS.

pht005345.v1.p1

1 itemgroup 5 items

pht005346.v1.p1

1 itemgroup 3 items

pht005347.v1.p1

1 itemgroup 8 items

pht005348.v1.p1

1 itemgroup 4 items

Eligibility

1 itemgroup 6 items

Serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

- 20/09/2021 - 1 formulario, 14 itemgroups, 62 items, 1 idioma
Itemgroups: General information, Serious adverse events, Serious adverse events description, Seriousness, Demography data, Recurrence of SAE, Possible Causes of SAE, Relevant medical conditions, Other relevant risk factors, Concomitant medications relevant to SAE, Details of Investigational Product, Details of relevant Assessments, Narrative Remarks, Investigator information
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Serious adverse events

Demography GSK study Dyskinesia in Parkinson's disease NCT00363727

- 20/09/2021 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: General information, Demography
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Demography.

PGx-Pharamacogenetic research GSK study Dyskinesia in Parkinson's disease NCT00363727 - PGx-Pharamacogenetic research study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 5 itemgroups, 12 items, 1 idioma
Itemgroups: General information, Consent PGx-Pharamacogenetic research, Blood sample collection (DNA), Withdrawal of consent, Blood sample destruction
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: PGx-Pharamacogenetic research.

Study conclusion GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 5 itemgroups, 13 items, 1 idioma
Itemgroups: General information, Pregnancy information, Study conclusion, Investigator comment log, Investigator signature
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Study conclusion.

Beck Depression Inventory GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 2 itemgroups, 4 items, 1 idioma
Itemgroups: General information, Beck Depression Inventory
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Beck Depression Inventory.

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: General information, Dyskinesia
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Dyskinesias.

PD Psychosis scale (PPRS) GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 2 itemgroups, 4 items, 1 idioma
Itemgroups: General information, Parkinson's Disease Psychosis Scale (PPRS)
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: PD Psychosis scale (PPRS).

PDQ39 - Questionnaire GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 2 itemgroups, 4 items, 1 idioma
Itemgroups: General information, Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: PDQ39 - Questionnaire.

Randomization/Drug dispensing GSK study Dyskinesia in Parkinson's disease NCT00363727 - Randomization/Drug dispensing study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 4 itemgroups, 8 items, 1 idioma
Itemgroups: General information, Total Daily L-Dopa Dosing, Randomization number, Drug dispensing
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease. Study part: Randomization/Drug dispensing

Investigational Product GSK study Dyskinesia in Parkinson's disease NCT00363727 - Investigational Product study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 3 itemgroups, 12 items, 1 idioma
Itemgroups: General information, Investigational product, Compliance
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Investigational Product.

L-Dopa medication GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08/09/2017 - 1 formulario, 4 itemgroups, 14 items, 1 idioma
Itemgroups: General information, L-Dopa medication changes, L-Dopa medication, Parkinson's disease symptom control
Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: L-Dopa medication

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