ID
33260
Description
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 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
Keywords
Versions (6)
- 12/3/18 12/3/18 -
- 1/22/19 1/22/19 -
- 1/22/19 1/22/19 -
- 1/22/19 1/22/19 -
- 1/25/19 1/25/19 - Sarah Riepenhausen
- 1/25/19 1/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 3, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold
Neurological Examination Form
- StudyEvent: ODM
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Protocol Time
Data type
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Study Day
Data type
text
Description
If no, please comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0884358
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Dizzines
Data type
boolean
Alias
- UMLS CUI [1]
- C0012833
Description
Vertigo
Data type
boolean
Alias
- UMLS CUI [1]
- C0042571
Description
Diplopia
Data type
boolean
Alias
- UMLS CUI [1]
- C0012569
Description
Nystagmus
Data type
boolean
Alias
- UMLS CUI [1]
- C0028738
Description
If yes, perform a full neurological examination (complete Neurological Examination page) and complete the subject’s Adverse Event source document book.
Data type
boolean
Alias
- UMLS CUI [1]
- C0221722
Description
Physician's Signature
Data type
text
Alias
- UMLS CUI [1]
- C1519316
Description
Conclusion
Alias
- UMLS CUI-1
- C1707478
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Neurological Examination Form
- StudyEvent: ODM
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