NCT00505687

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Geographic Reach
8 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 12, 2010

Completed
Last Updated

October 2, 2014

Status Verified

September 1, 2010

Enrollment Period

3.8 years

First QC Date

July 20, 2007

Results QC Date

December 8, 2009

Last Update Submit

September 24, 2014

Conditions

Idiopathic Parkinson's Disease

Keywords

RotigotineNeupro®

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    four years

  • 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)

Study Arms (1)

Rotigotine

EXPERIMENTAL

Rotigotine

Drug: Rotigotine

Interventions

RotigotineDRUG

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.

Also known as: Neupro
Rotigotine

Eligibility Criteria

Age31 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Fort Wayne, Indiana, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

Forest Hills, New York, United States

Location

Unknown Facility

Asheville, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Kassel, Germany

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Ancona, Italy

Location

Unknown Facility

Lucca, Italy

Location

Unknown Facility

Messina, Italy

Location

Unknown Facility

Pretoria, Gauteng, South Africa

Location

Unknown Facility

Parow, Western Cape, South Africa

Location

Unknown Facility

Plumstead, Western Cape, South Africa

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Barncose Terrace, Redruth, United Kingdom

Location

Unknown Facility

Bridgend, United Kingdom

Location

Unknown Facility

North Shields, United Kingdom

Location

Unknown Facility

Tyne and Wear, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

February 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 2, 2014

Results First Posted

January 12, 2010

Record last verified: 2010-09

Locations

IL(1)GB(4)ES(1)AU(1)IT(3)US(9)ZA(3)DE(4)