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78 Resultados de la búsqueda.
Relevancia Evaluación Nuevo primero Antiguo primero

Screenning: EDSS Multiple Sclerosis ALAIN01 NCT02419378

- 31/5/16 - 1 formulario, 1 itemgroup, 12 items, 1 idioma
Itemgroup: EDSS
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Screenning

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

- 20/4/22 - 1 formulario, 24 itemgroups, 70 items, 2 idiomas
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12

- 20/4/22 - 1 formulario, 22 itemgroups, 64 items, 2 idiomas
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , Urine Specimen Collection
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples - Treatment Phase Study Week 14

- 7/4/22 - 1 formulario, 24 itemgroups, 70 items, 1 idioma
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments and Clinical Laboratory Examination - Treatment Phase Study Week 10

- 7/4/22 - 1 formulario, 21 itemgroups, 60 items, 1 idioma
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG)
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 7/4/22 - 1 formulario, 28 itemgroups, 87 items, 1 idioma
Itemgroups: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Electrocardiography , Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Urine creatinine measurement, Plasma specimen, Clinical status, Clinical status; Finding
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 formulario, 10 itemgroups, 33 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Premature Study Withdrawal Visit

Visit 12 (Week 96) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 formulario, 10 itemgroups, 41 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 12 (Week 96)

Visit 6 (Week 24): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 formulario, 9 itemgroups, 31 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 6 (Week 24)

Visit 24 (Week 240) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18/2/22 - 1 formulario, 10 itemgroups, 41 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 24 (Week 240)

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18/2/22 - 1 formulario, 10 itemgroups, 41 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Relapse assessment, Subject Identification, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Unsceduled relapse assessment visit

Visit 8 (Week 32) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17/2/22 - 1 formulario, 10 itemgroups, 41 items, 1 idioma
Itemgroups: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 8 (Week 32)

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