ID
34729
Descripción
Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form is for documentation of the neurological examination. It should be filled out at each treatment period visit and the follow up visit. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose
Palabras clave
Versiones (6)
- 3/12/18 3/12/18 -
- 22/1/19 22/1/19 -
- 22/1/19 22/1/19 -
- 22/1/19 22/1/19 -
- 25/1/19 25/1/19 - Sarah Riepenhausen
- 25/1/19 25/1/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de enero de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Neurological Examination Form (Treatment period, Follow-up)
- StudyEvent: ODM
Descripción
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Descripción
Only applies to the treatment period visits
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Descripción
Date of Assessment
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Actual Time
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
If no, please comment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0884358
Descripción
Comment
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Descripción
Dizziness
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012833
- UMLS CUI [2]
- C0007760
Descripción
Vertigo
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0042571
- UMLS CUI [2]
- C0007760
Descripción
Diplopia
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012569
- UMLS CUI [2]
- C0007760
Descripción
Nystagmus
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0028738
- UMLS CUI [2]
- C0007760
Descripción
If yes, perform a full neurological examination (complete Neurological Examination page) and complete the subject’s Adverse Event source document book.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0221722
Descripción
Physician's Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519316
Similar models
Neurological Examination Form (Treatment period, Follow-up)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0007760 (UMLS CUI [2])
C0007760 (UMLS CUI [2])
C0007760 (UMLS CUI [2])
C0007760 (UMLS CUI [2])