An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00505687
• Collaborator: (none)
• Enrollment: 186
• Locations: 26
• Arm: 1
• Duration (Months): 46
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson's Disease	Drug: Rotigotine	Phase 3

Detailed Description

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rotigotine Rotigotine	Drug: Rotigotine; 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.; Other Names: Neupro

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [four years]

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

Secondary Outcome Measures

1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [four years]

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

2. Mean Epworth Sleepiness Scale Score During the Open-label Extension. [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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 31 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria:

• Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		St. Petersburg	Florida	United States
3		Fort Wayne	Indiana	United States
4		Southfield	Michigan	United States
5		Forest Hills	New York	United States
6		Asheville	North Carolina	United States
7		Raleigh	North Carolina	United States
8		Houston	Texas	United States
9		Milwaukee	Wisconsin	United States
10		Innsbruck		Austria	6020
11		Bochum		Germany
12		Dresden		Germany
13		Kassel		Germany
14		Ulm		Germany
15		Tel Aviv		Israel
16		Ancona		Italy
17		Lucca		Italy
18		Messina		Italy
19		Pretoria	Gauteng	South Africa
20		Parow	Western Cape	South Africa
21		Plumstead	Western Cape	South Africa
22		Barcelona		Spain
23		Barncose Terrace	Redruth	United Kingdom
24		Bridgend		United Kingdom
25		North Shields		United Kingdom
26		Tyne and Wear		United Kingdom

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00505687
• Other Study ID Numbers: SP0833; 2004-002641-12
• First Posted: Jul 23, 2007
• Last Update Posted: Oct 2, 2014
• Last Verified: Sep 1, 2010

• Keywords provided by UCB Pharma: Rotigotine; Neupro®
• Additional relevant MeSH terms: Parkinson Disease; Rotigotine

Study Results

Participant Flow

Recruitment Details	An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson's Disease in 26 locations from February 2005 to December 2008.

Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Period Title: Overall Study
STARTED	186
COMPLETED	91
NOT COMPLETED	95

Baseline Characteristics

Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Overall Participants	186
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	94 50.5%
>=65 years	92 49.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (10.4)
Sex: Female, Male (Count of Participants)
Female	60 32.3%
Male	126 67.7%
Region of Enrollment (participants) [Number]
United States	80 43%
Spain	9 4.8%
Austria	4 2.2%
South Africa	22 11.8%
Israel	20 10.8%
Germany	22 11.8%
United Kingdom	20 10.8%
Italy	9 4.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Measure Participants	186
Number [Subjects]	170

2. Secondary Outcome

Title	Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Description	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame	four years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Measure Participants	186
Number [Subjects]	48

3. Secondary Outcome

Title	Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Description	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.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
Measure Participants	186
Visit 6 (post year 1) (n=164)	9.3 (5.6)
Visit 10 (post year 2) (n=164)	10.0 (5.9)
Visit 14 (post year 3) (n=164)	10.3 (6.1)
End of Treatment (n=182)	10.1 (5.9)

Adverse Events

Time Frame	up to four years
Arm/Group Title	Rotigotine
Arm/Group Description	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
All Cause Mortality
	Rotigotine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rotigotine
	Affected / at Risk (%)	# Events
Total	45/186 (24.2%)
Blood and lymphatic system disorders
Anaemia	1/186 (0.5%)	1
Cardiac disorders
Angina pectoris	1/186 (0.5%)	1
Myocardial infarction	1/186 (0.5%)	1
Acute myocardial infarction	1/186 (0.5%)	1
Coronary artery stenosis	1/186 (0.5%)	1
Coronary artery occlusion	1/186 (0.5%)	1
Atrial fibrillation	1/186 (0.5%)	1
Gastrointestinal disorders
Constipation	1/186 (0.5%)	1
Pancreatitis	1/186 (0.5%)	1
Gastritis	1/186 (0.5%)	2
Intestinal obstruction	1/186 (0.5%)	1
General disorders
Asthenia	1/186 (0.5%)	1
Pyrexia	1/186 (0.5%)	1
Chest pain	1/186 (0.5%)	1
Hepatobiliary disorders
Cholecystitis	1/186 (0.5%)	1
Cholelithiasis	1/186 (0.5%)	1
Infections and infestations
Cellulitis	2/186 (1.1%)	3
Septic shock	1/186 (0.5%)	1
Urosepsis	1/186 (0.5%)	1
Pneumonia	1/186 (0.5%)	2
Urinary tract infection	1/186 (0.5%)	1
Injury, poisoning and procedural complications
Fall	2/186 (1.1%)	2
Femoral neck fracture	1/186 (0.5%)	1
Hip fracture	1/186 (0.5%)	1
Muscle strain	1/186 (0.5%)	1
Post procedural haematoma	1/186 (0.5%)	1
Lumbar vertebral fracture	1/186 (0.5%)	1
Brain contusion	1/186 (0.5%)	1
Humerus fracture	1/186 (0.5%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	3/186 (1.6%)	4
Arthralgia	2/186 (1.1%)	2
Toe deformity	1/186 (0.5%)	1
Fracture nonunion	1/186 (0.5%)	2
Arthritis	1/186 (0.5%)	1
Intervertebral disc protrusion	1/186 (0.5%)	1
Tendonitis	1/186 (0.5%)	1
Bursitis	1/186 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel	1/186 (0.5%)	1
Metastatic neoplasm	1/186 (0.5%)	1
Malignant fibrous histiocytoma	1/186 (0.5%)	1
Colon cancer	1/186 (0.5%)	2
Nervous system disorders
Parkinson's disease	3/186 (1.6%)	3
Parkinsonism	2/186 (1.1%)	3
Syncope	2/186 (1.1%)	2
Hypokinesia	1/186 (0.5%)	1
Dyskinesia	1/186 (0.5%)	1
Cerebrovascular accident	1/186 (0.5%)	1
Hydrocephalus	1/186 (0.5%)	1
Lumbar radiculopathy	1/186 (0.5%)	1
Peroneal nerve palsy	1/186 (0.5%)	1
Tremor	1/186 (0.5%)	1
Balance disorder	1/186 (0.5%)	1
Psychiatric disorders
Abnormal behaviour	1/186 (0.5%)	1
Depression	1/186 (0.5%)	1
Completed suicide	1/186 (0.5%)	1
Renal and urinary disorders
Urinary retention	1/186 (0.5%)	1
Pollakiuria	1/186 (0.5%)	1
Urge incontinence	1/186 (0.5%)	1
Renal failure	1/186 (0.5%)	1
Nephrolithiasis	1/186 (0.5%)	1
Renal colic	1/186 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/186 (0.5%)	1
Pleural effusion	1/186 (0.5%)	1
Skin and subcutaneous tissue disorders
Urticaria	1/186 (0.5%)	1
Surgical and medical procedures
Rehabilitation therapy	1/186 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Rotigotine
	Affected / at Risk (%)	# Events
Total	136/186 (73.1%)
Gastrointestinal disorders
Nausea	21/186 (11.3%)	27
Constipation	12/186 (6.5%)	14
General disorders
Oedema peripheral	36/186 (19.4%)	45
Application site erythema	24/186 (12.9%)	26
Application site pruritus	16/186 (8.6%)	17
Fatigue	10/186 (5.4%)	11
Injury, poisoning and procedural complications
Fall	29/186 (15.6%)	47
Musculoskeletal and connective tissue disorders
Back pain	21/186 (11.3%)	24
Pain in extremity	12/186 (6.5%)	14
Arthralgia	14/186 (7.5%)	16
Nervous system disorders
Somnolence	52/186 (28%)	58
Dizziness	18/186 (9.7%)	19
Parkinson's disease	10/186 (5.4%)	13
Psychiatric disorders
Insomnia	24/186 (12.9%)	25
Depression	19/186 (10.2%)	20
Anxiety	16/186 (8.6%)	20
Hallucination	11/186 (5.9%)	13
Abnormal dreams	11/186 (5.9%)	11
Sleep disorder	10/186 (5.4%)	10
Vascular disorders
Hypertension	11/186 (5.9%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.