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

- 18-12-18 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Physical 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 the result of the physical examination. It should be filled out at screening visit and updated throughout the study if necessary. 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 - Miscellaneous Information

- 18-12-18 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Miscellaneous Information, 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 miscellaneous information about the subject. It should be filled out at screening 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 - Details of Next of Kin and GP

- 18-12-18 - 1 Formulier, 4 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Details of Next of Kin, Details of General Practitioner, 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 next of kin, as well as the general practicioner of the subject. It should be filled out at the screening 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 - Dietary Status and Physical Activity

- 18-12-18 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Dietary Status and Physical Activity, 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 dietary status and physical activity. It should be filled out at the screening visit. Dietary Restricions: Subjects not to consume the following foodstuffs for five days prior to and including each dosing day:- - Grapfruit, Grapefruit juice and grapefruit containing products - Quinine – containing products - Broccoli - Brussel sprouts - Watercress - Cabbage (incl. Coleslaw) - Charcoal broiled beef Subjects will refrain from consuming caffeinated beverages for 48 hours prior to and including each dosing day Subjects must refrain from strenuous exercise for 48 hours before the screening medical examination and for the entire duration of 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 - Dermatological Drug Reaction History

- 16-12-18 - 1 Formulier, 2 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Dermatological Drug Reaction History
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 history of dermatological drug reactions. It should be filled out at each treatment period visit. Complete the Dermatological Drug Reaction History pages for each drug reaction experienced. 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 - TMS

- 11-12-18 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Transcranial Magnetic Stimulation, 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 concerning transcranial magnetic stimulation of the subject. It should be filled out at screening 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 - EEG

- 11-12-18 - 1 Formulier, 4 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Diagnostic EEG, Clinical Interpretation of EEG, 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 diagnostic EEG results. It should be filled out at the screening 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 - Subject Identification

- 08-12-18 - 1 Formulier, 4 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Subject Identification, Employment Status, 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 basic information of the subject. It should be filled out at the screening 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 - Subject Screening Checklist

- 08-12-18 - 1 Formulier, 5 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, General Information, Clinical Assessments, Laboratory Tests, 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 Checklist for the first screening of the study subject. It should be filled out at the screening visit. Every item should be checked and staff initials should be filled in next to the item. 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

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Pharmacodynamics and -kinetics (Sessions 1 and 2)

- 27-06-18 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Pharmacodynamics - Blood, Pharmacokinetics - Blood
This ODM file contains Collection Information on Pharmacodynamics and Pharmacokinetics. To be filled at Sessions 1 and 2 (Day 1, different timepoints). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Sammelverordnung Sub MS University Hospital Muenster (UKM) Subform

- 27-11-16 - 1 Formulier, 1 Itemgroep, 20 Data-elementen, 1 Taal
Itemgroep: General information section
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: Sammelverordnung Sub.

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