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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

- 12-02-19 - 1 Formulier, 12 Itemgroepen, 38 Data-elementen, 1 Taal

Itemgroepen: Administrative, Medication of special Interest , Medication of special Interest, Prior RLS Treatment Medications, Prior RLS Treatment Medications , Alcohol intake, Caffeine Intake, Current Tobacco Use, Restless Legs Syndrome History, International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria, Subject's Food Intake, 12-Lead ECG

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

visit week 36 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17-10-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 32 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17-10-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 30 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 17-10-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 20 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 16-10-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 16 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 16-10-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

visit week 14 food intake Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 20-09-17 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: administrative data, food intake before PK sampling, food intake on day of PK sampling

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Meal

- 12-11-19 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Meal

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record details about the meal the subject consumed at Visit 2.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 12 101468/169 NCT00381472

- 17-09-17 - 1 Formulier, 21 Itemgroepen, 65 Data-elementen, 1 Taal

Itemgroepen: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING, SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING, PHARMACOKINETICS - BLOOD, CLINICAL GLOBAL IMPRESSION, UNIFIED PARKINSONS DISEASE RATING SCALE, PARKINSON’S DISEASE SLEEP SCALE, BECK DEPRESSION INVENTORY, EPWORTH SLEEPINESS SCALE, PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE (PDQ-39), INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, DIARY CARD, CONTINUATION

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 12 form.

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