An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00599196

First received: December 24, 2007

Last updated: August 30, 2011

Last verified: September 2010

History of Changes

Results First Received: December 11, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Early Stage 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 to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.

Reporting Groups

	Description
Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Participant Flow: Overall Study

	Rotigotine
STARTED	381
COMPLETED	0 ^[1]
NOT COMPLETED	381
Lack of Efficacy	22
Adverse Event	93
Unsatisfactory compliance of subject	3
Subject withdrew consent	43
Study ended per sponsor	197
Lost to Follow-up	17
Other: Patient Leaving For Israel	1
Other: Spouse Withdrew Consent	1
Other: Diagnosis No Longer Idiopathic Pd	1
Other: Pt Moved To Australia	1
Other: Patient Stopped Due To Moving	1
Other: Inv Switched Dopamine Agonist	1

[1]	Study fully recruited. Completed upon market authorization and commercial availability of Neupro.

Baseline Characteristics

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Reporting Groups

	Description
Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Baseline Measures

	Rotigotine
Number of Participants [units: participants]	380
Age ^[1] [units: participants]
<=18 years	0
Between 18 and 65 years	215
>=65 years	165
Age [units: years] Mean ± Standard Deviation	61.6 ± 10.0
Gender [units: participants]
Female	150
Male	230
Region of Enrollment [units: participants]
Finland	16
Spain	10
Austria	12
Israel	30
United Kingdom	38
Italy	9
Switzerland	4
France	10
Czech Republic	44
Hungary	17
Poland	65
Belgium	12
Croatia	17
Australia	7
South Africa	42
Germany	7
Norway	4
Netherlands	5
New Zealand	19
Sweden	12

[1]	Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the Safety Set because he withdrew consent prior to receiving any Open Label study medication.

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: six years ]

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2. Secondary:

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

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3. Secondary:

Mean Epworth Sleepiness Scale Score During the Open-label Extension [ Time Frame: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit) ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00599196 History of Changes
Other Study ID Numbers:	SP716, SP513OL
Study First Received:	December 24, 2007
Results First Received:	December 11, 2009
Last Updated:	August 30, 2011
Health Authority:	Austria: Agency for Health and Food Safety Australia: Department of Health and Ageing Therapeutic Goods Administration Croatia: Ministry of Science, Education and Sports Belgium: Directorate general for the protection of Public health: Medicines Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Finland: Finnish Medicines Agency Hungary: National Institute of Pharmacy Israel: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) New Zealand: Health Research Council Norway: Norwegian Medicines Agency Poland: Ministry of Health South Africa: Department of Health Sweden: Medical Products Agency Switzerland: Swissmedic Italy: Ministry of Health Spain: Comité Ético de Investigación Clínica United Kingdom: Medicines and Healthcare Products Regulatory Agency

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