ID
34676
Beschrijving
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
Trefwoorden
Versies (6)
- 03-12-18 03-12-18 -
- 22-01-19 22-01-19 -
- 22-01-19 22-01-19 -
- 22-01-19 22-01-19 -
- 25-01-19 25-01-19 - Sarah Riepenhausen
- 25-01-19 25-01-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Neurological Examination Form (Visit)
- StudyEvent: ODM
Beschrijving
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Only applies to the treatment period visits
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Actual Time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
If no, please comment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0884358
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Dizzines
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012833
- UMLS CUI [2]
- C0007760
Beschrijving
Vertigo
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042571
- UMLS CUI [2]
- C0007760
Beschrijving
Diplopia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012569
- UMLS CUI [2]
- C0007760
Beschrijving
Nystagmus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0028738
- UMLS CUI [2]
- C0007760
Beschrijving
If yes, perform a full neurological examination (complete Neurological Examination page) and complete the subject’s Adverse Event source document book.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221722
Beschrijving
Physician's Signature
Datatype
text
Alias
- UMLS CUI [1]
- C1519316
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