Early-Stage Parkinson's DiseasePhase 3SP512OLNCT00594165

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

A Phase 3 study testing Rotigotine in people with Early-Stage Parkinson's Disease, run by UCB Pharma at 42 sites in 2 countries.

Completed

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

Official record

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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 early-stage idiopathic Parkinson's disease. Read more about this study

Who is it for?: Ages 31 years and older
Conditions the study is for: Early-Stage Parkinson's Disease
What is being tested?: Rotigotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 217 participants
Where: 42 sitesin 2 countries
Study dates: Jun 2002to Nov 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 SP512 double-blind trial

Who cannot join

Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication

Trial locations and contacts

42 sites in 2 countries.

Country

City, postcode or hospital

42 sites in 2 countries

United States37 sites

Study site
Albany, New York
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Asheville, North Carolina
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Atlanta, Georgia
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Boston, Massachusetts
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Chicago, Illinois
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Cleveland, Ohio
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Columbus, Ohio
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Dallas, Texas
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Danbury, Connecticut
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Durham, North Carolina
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Englewood, Colorado
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Fort Wayne, Indiana
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Fountain Valley, California
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Fresno, California
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Henderson, Nevada
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Houston, Texas
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Los Angeles, California
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Louisville, New York
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Miami, Florida
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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New Brunswick, New Jersey
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New Haven, Connecticut
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New Orleans, Louisiana
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New York, New York
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Peoria, Arizona
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Phoenix, Arizona
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Pompano Beach, Florida
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Richmond, Virginia
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Roanoke, Virginia
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San Antonio, Texas
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Southfield, Michigan
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St Louis, Missouri
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Sunrise, Florida
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Toledo, Ohio
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Tucson, Arizona
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Upland, Pennsylvania

Other trials in United States

Canada5 sites

Study site
Calgary, Alberta
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Edmonton, Alberta
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Ottawa, Ontario
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Saskatoon, Saskatchewan
Study site
Vernon, British Columbia

Other trials in Canada

About this study

Official title: An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-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 early-stage idiopathic Parkinson's disease.

Read the detailed description

This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Conditions: Early-Stage Parkinson's Disease
Being tested: Rotigotine
Keywords: Rotigotine
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 trans-dermal 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 NCT00594165
Study group	Role	What they receive
Rotigotine	Experimental	Rotigotine 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: 7 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: 7 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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (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.

Jun 2002Nov 2008

First posted15 Jan 2008 (estimated)
Study startJun 2002
Primary completionNov 2008
Study completionNov 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Early-Stage 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: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00594165
Sponsor's protocol ID: SP0702
Other IDs: SP512OL
Acronym: SP512OL
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

Publications

Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.
PubMed 22326237

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

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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
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Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
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RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
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RecruitingPhase 2/3
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
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All Early-Stage 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 SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.
ClinicalTrials.gov ID: NCT00594165
Acronym / sponsor ID: SP512OL / SP0702
Conditions: Early-Stage Parkinson's Disease
Keywords: Rotigotine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Jun 2002
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 15 Jan 2008 (estimated)
Results: Posted 25 Feb 2010

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 early-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: RotigotineRotigotine

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 SP512 double-blind trial

Key exclusion criteria (1 listed)

Subjects who had an ongoing serious adverse event from SP512 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 trans-dermal 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: 7 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: 7 years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Time frame: Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

Results and safety

Results posted to the registry on 25 Feb 2010, 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	217	0

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

Time frame: 7 years. Number. Unit: Subjects

Measure	Rotigotine n = 216
Value	214

Population analysed: Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotigotine	102 of 216 (47.2%)	206 of 216 (95.4%)	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.
Results publication: PubMed 22326237Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Early-Stage Parkinson's Disease

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Parkinson's Disease
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease
Parkinson Disease
RecruitingPhase 1
A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.
Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease

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)

42 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 Early-Stage Parkinson's Disease, run by UCB Pharma at 42 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 42 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 25 Feb 2010). 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: 7 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 NCT00594165, which also lists 1 linked publication.

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.