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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00505687

First received: July 20, 2007

Last updated: September 24, 2014

Last verified: September 2010

History of Changes

Results First Received: December 8, 2009

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Idiopathic Parkinson's Disease
Intervention:	Drug: Rotigotine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	Rotigotine
STARTED	186
COMPLETED	91
NOT COMPLETED	95
Important protocol violation	2
Lack of Efficacy	15
Adverse Event	48
Subject withdrew consent	15
Lost to Follow-up	1
Other: Underwent Implantation Of DBS	1
Other: Scheduled DBS Surgery	1
Other: Prolonged Hospitalization	1
Other: Patches Would Not Stick D/T Sweat	1
Other: Neupro Given In Hospital	1
Other: Disease Progression	1
Other: As Per Sponsor	8

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

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

Baseline Measures

	Rotigotine
Overall Participants Analyzed [Units: Participants]	186

Age [Units: Participants]
<=18 years	0
Between 18 and 65 years	94
>=65 years	92

Age [Units: Years] Mean (Standard Deviation)	62.5 (10.4)

Gender [Units: Participants]
Female	60
Male	126

Region of Enrollment [Units: Participants]
United States	80
Spain	9
Austria	4
South Africa	22
Israel	20
Germany	22
United Kingdom	20
Italy	9

Outcome Measures

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1. Primary:

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

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2. Secondary:

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: four years ]

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3. Secondary:

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

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Serious Adverse Events

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Time Frame	up to four years
Additional Description	No text entered.

Reporting Groups

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

Serious Adverse Events

	Rotigotine
Total, Serious Adverse Events
# participants affected / at risk	45/186 (24.19%)
Blood and lymphatic system disorders
Anaemia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Cardiac disorders
Angina pectoris ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Myocardial infarction ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Acute myocardial infarction ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Coronary artery stenosis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Coronary artery occlusion ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Atrial fibrillation ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Gastrointestinal disorders
Constipation ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Pancreatitis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Gastritis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	2
Intestinal obstruction ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
General disorders
Asthenia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Pyrexia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Chest pain ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Hepatobiliary disorders
Cholecystitis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Cholelithiasis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Infections and infestations
Cellulitis ^* 1
# participants affected / at risk	2/186 (1.08%)
# events	3
Septic shock ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Urosepsis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Pneumonia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	2
Urinary tract infection ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Injury, poisoning and procedural complications
Fall ^* 1
# participants affected / at risk	2/186 (1.08%)
# events	2
Femoral neck fracture ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Hip fracture ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Muscle strain ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Post procedural haematoma ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Lumbar vertebral fracture ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Brain contusion ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Humerus fracture ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Musculoskeletal and connective tissue disorders
Osteoarthritis ^* 1
# participants affected / at risk	3/186 (1.61%)
# events	4
Arthralgia ^* 1
# participants affected / at risk	2/186 (1.08%)
# events	2
Toe deformity ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Fracture nonunion ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	2
Arthritis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Intervertebral disc protrusion ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Tendonitis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Bursitis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Metastatic neoplasm ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Malignant fibrous histiocytoma ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Colon cancer ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	2
Nervous system disorders
Parkinson's disease ^* 1
# participants affected / at risk	3/186 (1.61%)
# events	3
Parkinsonism ^* 1
# participants affected / at risk	2/186 (1.08%)
# events	3
Syncope ^* 1
# participants affected / at risk	2/186 (1.08%)
# events	2
Hypokinesia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Dyskinesia ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Cerebrovascular accident ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Hydrocephalus ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Lumbar radiculopathy ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Peroneal nerve palsy ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Tremor ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Balance disorder ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Psychiatric disorders
Abnormal behaviour ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Depression ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Completed suicide ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Renal and urinary disorders
Urinary retention ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Pollakiuria ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Urge incontinence ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Renal failure ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Nephrolithiasis ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Renal colic ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Pleural effusion ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Skin and subcutaneous tissue disorders
Urticaria ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1
Surgical and medical procedures
Rehabilitation therapy ^* 1
# participants affected / at risk	1/186 (0.54%)
# events	1

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (9.1)

Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493

Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT00505687 History of Changes
Other Study ID Numbers:	SP0833 2004-002641-12 ( EudraCT Number )
Study First Received:	July 20, 2007
Results First Received:	December 8, 2009
Last Updated:	September 24, 2014

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