ID
34729
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 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
Mots-clés
Versions (6)
- 03/12/2018 03/12/2018 -
- 22/01/2019 22/01/2019 -
- 22/01/2019 22/01/2019 -
- 22/01/2019 22/01/2019 -
- 25/01/2019 25/01/2019 - Sarah Riepenhausen
- 25/01/2019 25/01/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
25 janvier 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Effect of Lamictal on Resting Motor Threshold Study-ID 107434
Neurological Examination Form (Treatment period, Follow-up)
- StudyEvent: ODM
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Only applies to the treatment period visits
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2348563
Description
Date of Assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
If no, please comment
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0884358
Description
Comment
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Dizziness
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012833
- UMLS CUI [2]
- C0007760
Description
Vertigo
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042571
- UMLS CUI [2]
- C0007760
Description
Diplopia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0012569
- UMLS CUI [2]
- C0007760
Description
Nystagmus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0028738
- UMLS CUI [2]
- C0007760
Description
If yes, perform a full neurological examination (complete Neurological Examination page) and complete the subject’s Adverse Event source document book.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0221722
Description
Physician's Signature
Type de données
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])