Parkinson's DiseasePhase 3SP715NCT00594386

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

A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease. Read more about this study

Who is it for?: Ages 31 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Rotigotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 41 sitesin 2 countries
Study dates: Aug 2002to Dec 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 31 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial

Who cannot join

Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication

Trial locations and contacts

41 sites in 2 countries.

Country

City, postcode or hospital

41 sites in 2 countries

United States37 sites

Study site
Albany, New York
Study site
Asheville, North Carolina
Study site
Atlanta, Georgia
Study site
Boston, Massachusetts
Study site
Danbury, Connecticut
Study site
Fairfield, Connecticut
Study site
Forest Hills, New York
Study site
Fort Wayne, Indiana
Study site
Fountain Valley, California
Study site
Fresno, California
Study site
Henderson, Nevada
Study site
Hoffman Estates, Illinois
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Irvine, California
Study site
Kansas City, Kansas
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Louisville, New York
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
New Haven, Connecticut
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Pompano Beach, Florida
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Roanoke, Virginia
Study site
San Antonio, Texas
Study site
Southfield, Michigan
Study site
St. Petersburg, Florida
Study site
Sunrise, Florida
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Upland, Pennsylvania

Other trials in United States

Canada4 sites

Study site
Edmonton, Alberta
Study site
Montrél, Quebec
Study site
Ottawa, Ontario
Study site
Saskatoon, Saskatchewan

Other trials in Canada

About this study

Official title: An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.

Read the detailed description

This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

Conditions: Parkinson's Disease
Being tested: Rotigotine
Keywords: Rotigotine, Neupro
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RotigotineDrug
Also called Neupro
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:
During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.
After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Study groups in NCT00594386
Study group	Role	What they receive
Rotigotine	Experimental	Not described Receives: Drug: Rotigotine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 years

Secondary outcomes (2)

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Measured: 6 years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
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.
Measured: Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2002Dec 2008

First posted15 Jan 2008 (estimated)
Study startAug 2002
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00594386
Sponsor's protocol ID: SP0715
Acronym: SP715
Status last verified: Sep 2010
First submitted: 24 Dec 2007
Last updated: 2 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.
ClinicalTrials.gov ID: NCT00594386
Acronym / sponsor ID: SP715 / SP0715
Conditions: Parkinson's Disease
Keywords: Rotigotine, Neupro
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2002
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 15 Jan 2008 (estimated)
Results: Posted 18 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rotigotine	Experimental	Drug: Rotigotine

Who may qualify

Ages: 31 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial

Key exclusion criteria (1 listed)

Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RotigotineAlso: NeuproRotigotine 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: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.	Drug	Rotigotine

Primary outcome

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Time frame: 6 years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

2 secondary outcomes

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
Time frame: 6 years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Time frame: Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

Results and safety

Results posted to the registry on 18 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rotigotine	258	0

Primary outcome: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

Time frame: 6 years. Number. Unit: Subjects

Measure	Rotigotine n = 258
Value	258

Population analysed: Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotigotine	165 of 258 (64%)	253 of 258 (98.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.
Product InformationLink provided by the sponsor.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

41 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 41 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00594386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.