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This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.
Study design was changed and an amendment was prepared accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Optimal dose after titration period 0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Optimal dose after titration period 0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2) 1 patch /day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | Visit 1 (Day 1) through End of Study (approximately 2 years) |
| Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | From Visit 1 (Day 1) through End of Study (approximately 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 1-877-822-9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 012 | Los Angeles | California | United States | |||
| 009 |
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| Label | URL |
|---|---|
| Product Information | View source |
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication.
This study started to enroll subjects in USA in January 2012 and concluded in December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Orange |
| California |
| United States |
| 014 | Spring Hill | Florida | United States |
| 013 | Indianapolis | Indiana | United States |
| 001 | Destrehan | Louisiana | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | All enrolled subjects who received at least 1 dose of study medication were included in the SS. | Posted | Number | subjects | Visit 1 (Day 1) through End of Study (approximately 2 years) |
|
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| ||||||||||||||||||||||||||
| Primary | Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | All enrolled subjects who received at least 1 dose of study medication were included in the SS. | Posted | Number | subjects | From Visit 1 (Day 1) through End of Study (approximately 2 years) |
|
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Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months).
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotigotine (Safety Set) | The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2). | 0 | 14 | 10 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Febrile disorders | General disorders | MedDRA9.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA9.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA9.1 | Non-systematic Assessment |
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| Electrocardiogram QT corrected interval prolonged | Investigations | MedDRA9.1 | Non-systematic Assessment |
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| Blood sodium increased | Investigations | MedDRA9.1 | Non-systematic Assessment |
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| Toxicology laboratory analyses | Investigations | MedDRA9.1 | Non-systematic Assessment |
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| Drug screen positive | Investigations | MedDRA9.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA9.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA9.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Sudden onset of sleep | Nervous system disorders | MedDRA9.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA9.1 | Non-systematic Assessment |
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| Enuresis | Renal and urinary disorders | MedDRA9.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA9.1 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA9.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA9.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA9.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Registries and Results Disclosure | UCB BIOSCIENCES GmbH | 40789+49 2173 48 | 15 15 | clinicaltrials@ucb.com |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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