Clinical trial NCT00505687: An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 186
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
timeFrame: four years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
timeFrame: four years
measure: Mean Epworth Sleepiness Scale Score During the Open-label Extension.
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: St. Petersburg
country: United States
state: Florida
city: Fort Wayne
country: United States
state: Indiana
city: Southfield
country: United States
state: Michigan
city: Forest Hills
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Innsbruck
country: Austria
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Kassel
country: Germany
city: Ulm
country: Germany
city: Tel Aviv
country: Israel
city: Ancona
country: Italy
city: Lucca
country: Italy
city: Messina
country: Italy
city: Pretoria
country: South Africa
state: Gauteng
city: Parow
country: South Africa
state: Western Cape
city: Plumstead
country: South Africa
state: Western Cape
city: Barcelona
country: Spain
city: Barncose Terrace
country: United Kingdom
state: Redruth
city: Bridgend
country: United Kingdom
city: North Shields
country: United Kingdom
city: Tyne and Wear
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: