Parkinson's DiseasePhase 3NCT00519532

Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma at 21 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated. Read more about this study

Who is it for?: Ages 18 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: 84 participants
Where: 21 sitesin 11 countries
Study dates: Jul 2007to May 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of trial SP889

Who cannot join

Ongoing serious adverse event assessed as related to trial medication

Trial locations and contacts

21 sites in 11 countries.

Country

City, postcode or hospital

21 sites in 11 countries

Germany6 sites

Study site
Berlin, 10713
Study site
Dresden, 01307
Study site
Kassel, 34128
Study site
Marburg, 35039
Study site
Naumburg, 06618
Study site
Ulm, 89081

Other trials in Germany

United States2 sites

Study site
Salisbury, North Carolina, 28144
Study site
St. Petersburg, Florida, 33701

Other trials in United States

Hungary2 sites

Study site
Budapest, 1145
Study site
Nyíregyháza, 4400

Other trials in Hungary

Italy2 sites

Study site
Chieti
Study site
Milan, 20127

Other trials in Italy

Spain2 sites

Study site
Barcelona
Study site
Madrid

Other trials in Spain

United Kingdom2 sites

Study site
Lancashire
Study site
Liverpool, L9 7JL

Other trials in United Kingdom

Australia1 site

Study site
Concord

Other trials in Australia

Finland1 site

Study site
Oulu, 90220

Other trials in Finland

New Zealand1 site

Study site
Christchurch

Other trials in New Zealand

Poland1 site

Study site
Olyszytn

Other trials in Poland

South Africa1 site

Study site
Cape Town

Other trials in South Africa

About this study

Official title: A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease

Conditions: Parkinson's Disease
Being tested: Rotigotine
Keywords: Neupro®, Rotigotine, Parkinson's Disease
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:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h

Study groups in NCT00519532
Study group	Role	What they receive
Rotigotine	Experimental	Rotigotine Transdermal Patch Receives: Drug: Rotigotine

What is being measured

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

Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Baseline is defined as first titration visit (T1) of SP915.
Measured: Baseline (baseline SP915) and week 13 (End of maintenance)
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Measured: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Secondary outcomes (2)

Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Measured: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
The change in number of nocturias was used to evaluate improvements in sleep disorders.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Measured: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Timeline

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

Jul 2007May 2009

First posted22 Aug 2007 (estimated)
Study startJul 2007
Primary completionMay 2009
Study completionMay 2009

Why it stopped: Due to clinical trial supplies shortage

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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00519532
Sponsor's protocol ID: SP0915
Other IDs: EudraCT number: 2006-006907-35
Status last verified: Sep 2010
First submitted: 21 Aug 2007
Last updated: 27 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

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease
ClinicalTrials.gov ID: NCT00519532
Acronym / sponsor ID: SP0915
Conditions: Parkinson's Disease
Keywords: Neupro®, Rotigotine, Parkinson's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to clinical trial supplies shortage
Enrolment: 84 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 22 Aug 2007 (estimated)
Results: Posted 2 Apr 2010

Clinical summary

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

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 Transdermal Patch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Completion of trial SP889

Key exclusion criteria (1 listed)

Ongoing serious adverse event assessed as related to trial 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 transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h	Drug	Rotigotine

Primary outcome

Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
Time frame: Baseline (baseline SP915) and week 13 (End of maintenance)
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915.
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889.

2 secondary outcomes

Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Results and safety

Results posted to the registry on 2 Apr 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	84	66

Primary outcome: Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)

Time frame: Baseline (baseline SP915) and week 13 (End of maintenance). Mean (Standard Deviation). Unit: units on a scale

Measure	Rotigotine n = 76
Value	-5.8 (9.4)

Population analysed: Full Analysis Set (FAS).

Primary outcome: Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)

Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance). Mean (Standard Deviation). Unit: units on a scale

Measure	Rotigotine n = 78
Value	-5.8 (7.8)

Population analysed: Full Analysis Set (FAS).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotigotine	16 of 84 (19%)	55 of 84 (65.5%)	Not reported

Limitations and caveats (from the sponsor): Because the manufacturing process for rotigotine patches was changed, enrollment into SP915 was stopped in April 2008 to ensure sufficient trial medication for all subjects enrolled at that time to complete the trial according to the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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)

21 sites in 11 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 21 sites in 11 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: stopped early, as of the sponsor's last update on 27 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 21 sites in Germany, United States, Hungary, Italy, Spain and 6 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 2 Apr 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?

Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) (time frame: Baseline (baseline SP915) and week 13 (End of maintenance)). The study lists 2 primary outcomes in all. 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 NCT00519532.

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 27 Oct 2014.