Early Stage Parkinson's DiseasePhase 3NCT00599196
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 63 sites in 20 countries.
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 30 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
- 381 participants
- Where
- 63 sitesin 20 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 30 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 SP513 double-blind trial
Who cannot join
- Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Trial locations and contacts
63 sites in 20 countries.
63 sites in 20 countries
Poland7 sites
Study site
Gdansk
Study site
Katowice
Study site
Krakόw
Study site
Lublin
Study site
Mosina k/Poznania
Study site
Olsztyn
Study site
Warsaw
United Kingdom7 sites
Study site
Birmingham
Study site
Blackpool
Study site
Glasgow
Study site
Liverpool
Study site
London
Study site
Newcastle upon Tyne
Study site
Swansea
Finland5 sites
Study site
Espoo
Study site
Kuopio
Study site
Lappeenranta
Study site
Oulu
Study site
Pori
Australia4 sites
Study site
Concord
Study site
Darlinghurst
Study site
East Gosford
Study site
Westmead
Germany4 sites
Study site
Aachen
Study site
Dresden
Study site
Kiel
Study site
Marburg
New Zealand4 sites
Study site
Auckland
Study site
Christchurch
Study site
North Shore
Study site
Wellington
About this study
Official title: An Open-Label Extension to the Double-Blind SP513 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- and ropinirole-controlled SP513 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, Neupro®
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, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.
After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.
| 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: six 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: six 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 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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.
- 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
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599196
- Sponsor's protocol ID
- SP0716
- Other IDs
- SP513OL
- 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
Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.
PubMed 23508526
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 SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00599196
- Acronym / sponsor ID
- SP0716
- Conditions
- Early Stage Parkinson's Disease
- Keywords
- Rotigotine, Neupro®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 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
- 23 Jan 2008 (estimated)
- Results
- Posted 18 Jan 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
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease
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
- 30 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 SP513 double-blind trial
Key exclusion criteria (1 listed)
- Subjects who had an ongoing serious adverse event from SP513 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: Neupro®Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 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: six 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: six years
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)
Results and safety
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.
- Derived from this study: PubMed 23508526Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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)
63 sites in 20 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 63 sites in 20 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 63 sites in Poland, United Kingdom, Finland, Australia, Germany and 15 more countries. 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 Jan 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: six 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 NCT00599196, 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.