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Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 27/9/21 - 1 formulario, 8 itemgroups, 98 items, 1 idioma

Itemgroups: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities

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 contains information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Dermatological/Hypersensitivity Adverse Event Form

- 20/9/21 - 1 formulario, 11 itemgroups, 66 items, 1 idioma

Itemgroups: Administrative Data, Dermatological/Hypersensitivity Adverse Event, Systemic Symptoms, Signs or Laboratory Abnormalities, Haematologic Abnormalities, Supportive/Investigative Measures, Diagnosis, Responsible for Diagnosis, Lesion Location, Concomitant Medication, Infections, Conclusion

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 contains information about any dermatological or hypersensitivity adverse event form. It should be filled out when any of those occur during the study. Record details of any dematological/hypersensitivity adverse event in the appropriate Non-Serious Adverse/Serious Adverse Event section of the CRF. 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Neurological Examination Record

- 28/1/19 - 1 formulario, 4 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative Data, Neurological Examination, Neurological Examination Results, Neurological Examination Conclusion

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 contains information about any recorded neurological abnormalities during the study. It should be filled out at screening and anytime an additional neurological examination is performed.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Concomitant Medication

- 25/1/19 - 1 formulario, 4 itemgroups, 18 items, 1 idioma

Itemgroups: Administrative Data, Concomitant Medication, Concomitant Medication Details, Conclusion

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 contains information about any concomitant medication the subject used during the study. It should be filled out at screening (, transcribed to the main form) and updated every 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - 12-Lead ECG Form

- 23/1/19 - 1 formulario, 2 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative Data, 12-Lead Electrocardiogram

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 ECG. It should be filled out at each study visit. 3 measurements will be taken Pre dose on Day 1, the baseline will be considered the mean of the 3 measurements on day 1. 1 measurement will be taken post dose on day 2 and 3. Unscheduled ECGs should be documented in this form whenever they are performed during the study. 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Unscheduled 12-Lead ECG Form

- 23/1/19 - 1 formulario, 2 itemgroups, 8 items, 1 idioma

Itemgroups: Administrative Data, Unscheduled 12-Lead Electrocardiogram

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 Unscheduled ECGs should be documented in this form whenever they are performed during the study. If an ECG is deemed Abnormal, clinically significant, complete the “ECG Abnormalities” page in the CRF. 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG (Screening)

- 23/1/19 - 1 formulario, 3 itemgroups, 9 items, 1 idioma

Itemgroups: Administrative Data, 12-Lead Electrocardiogram, Conclusion

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 contains information about the subjects 12-lead electrocardiogram. All ECGs will be recorder after 10 minutes rest in the semi-supine position. It should be filled out at screening visit. Unscheduled ECGs should be recorded whenever they have been performed 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Serious Adverse Event Notification Form

- 18/1/19 - 1 formulario, 15 itemgroups, 62 items, 1 idioma

Itemgroups: Administrative Data, Serious Adverse Event, SECTION 1: Serious Adverse Event Record, SECTION 2: Seriousness, SECTION 3: Demography Data, SECTION 4: Serious Adverse Event Recurrence, SECTION 5: Causes of SAE, SECTION 6: Relevant Medical Conditions, SECTION 7: Other Relevant Risk Factors, SECTION 8: Relevant Concomitant Medications, SECTION 9: Details of Investigational Product(s), SECTION 10: Details of Relevant Assessments, SECTION 11: Narrative Remarks, Conclusion, SECTION 12: Additional/Follow-Up Information

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 The purpose of this form is to document any serious adverse events. A serious adverse event is defined as follows: A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. SECTION 4: If Investigational Product was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s)Were Administered? If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur? SECTION 9: Details of Investigational Product Complete this section using the information in the Investigational Product page. Details of all investigational product(s) taken until the time of the SAE should be included. Provide specific details in Section 11 Narrative Remarks if the subject has taken an overdose of investigational product(s), including whether it was accidental or intentional. SECTION 12: SAE Additional/Follow-up Information On receipt of follow-up information, the appropriate section(s) on the SAE form must be amended/updated with any changes (i.e., diagnosis, end date or death, change in intensity, or causality). These changes must be initialled and dated with confirmation by the investigator with his/her re-signing the form and forwarded to GSK within 24 hours. The investigator and others responsible for subject care should institute any supplementary investigations of SAEs based on their clinical judgement of the likely causative factors. This may include seeking a further opinion from a specialist in the field of the AE. GSK may also request extra tests or extra follow-up information. If a subject dies, any post-mortem/autopsy findings, including histopathology, must be provided to GSK.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Pregnancy Notification Form

- 18/1/19 - 1 formulario, 6 itemgroups, 45 items, 1 idioma

Itemgroups: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Study Withdrawal, Reporting Investigator Information

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 should be completed according to the protocol reporting requirements. Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Medical History Update

- 11/1/19 - 1 formulario, 3 itemgroups, 8 items, 1 idioma

Itemgroups: Administrative Data, Medical History Update, Conclusion

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 records updates in the medical history of the subject. It should be checked at each visit after the screening. 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

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Semi-Supine Vital Signs (Treatment Period)

- 11/1/19 - 1 formulario, 3 itemgroups, 18 items, 1 idioma

Itemgroups: Administrative Data, Semi-supine Vital Signs, Baseline Vital Signs

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 measurement of vital signs in the semi-supine position. It should be filled out at each treatment period visit. 3 measurements will be taken predose on Day 1, the baseline will be considered the mean of the 3 measurements 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

Effect of Lamictal on Resting Motor Threshold Study ID: 107434 - Vital signs

- 11/1/19 - 1 formulario, 3 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative Data, Vital Signs, Conclusion

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 contains informations about the subjects vital signs. The subject should be resting in semi-supine position for 10 minutes before each reading. It should be filled out at the screening visit and at the follow-up. 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

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