An Open-Label Extension Trial to Assess the Safety and To... | NCT00505687

ID	Type	Description	Link
2004-002641-12	EudraCT Number

Label	Type	Description	Intervention Names
Rotigotine	Experimental	Rotigotine	Drug: Rotigotine

Name	Type	Description	Arm Group Labels	Other Names
Rotigotine	Drug	Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.

Measure	Description	Time Frame
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	four years

Measure	Description	Time Frame
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	four years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Label	URL
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

ID	Title	Description
BG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	BG000186

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 With at Least One Adverse Event During This Open-label Extension Study

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).

Number

Subjects

four years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	OG000186

Title

Denominators

Categories

Title	Measurements
	OG000170

Secondary

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).

Number

Subjects

four years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	OG000186

Secondary

Mean Epworth Sleepiness Scale Score During the Open-label Extension.

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.

Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.

Mean

Standard Deviation

Score on a scale

Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Gastritis	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected186 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Asthenia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pyrexia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Chest pain	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Cellulitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0003 events2 affected186 at risk
Septic shock	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Urosepsis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected186 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected186 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events3 affected186 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected186 at risk
Toe deformity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected186 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Malignant fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected186 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected186 at risk
Parkinsonism	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events2 affected186 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected186 at risk
Hypokinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Hydrocephalus	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Balance disorder	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Completed suicide	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Urinary retention	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Urge incontinence	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Renal failure	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Renal colic	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected186 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00027 events21 affected186 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected186 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00045 events36 affected186 at risk
Application site erythema	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00026 events24 affected186 at risk
Application site pruritus	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00017 events16 affected186 at risk
Fatigue	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00011 events10 affected186 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG00047 events29 affected186 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00024 events21 affected186 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected186 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events14 affected186 at risk
Somnolence	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00058 events52 affected186 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00019 events18 affected186 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00013 events10 affected186 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00025 events24 affected186 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00020 events19 affected186 at risk
Anxiety	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00020 events16 affected186 at risk
Hallucination	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00013 events11 affected186 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00011 events11 affected186 at risk
Sleep disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00010 events10 affected186 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG00011 events11 affected186 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases