Parkinson's DiseasePhase 3NCT00243971
A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
A Phase 3 study testing SPM 962 in people with Parkinson's Disease, run by UCB Pharma at 1 site in Germany.
Trial summary
The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD. 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?
- SPM 962
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Nov 2004to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Early-stage, idiopathic Parkinson's disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD.
Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.
The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.
- Conditions
- Parkinson's Disease
- Being tested
- SPM 962
- Keywords
- EARLY-STAGE, IDIOPATHIC 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.
SPM 962Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startNov 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243971
- Sponsor's protocol ID
- SP0825
- Other IDs
- 2004-002609-66, 2004
- Status last verified
- Sep 2009
- First submitted
- 24 Oct 2005
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00243971
- Acronym / sponsor ID
- SP0825
- Conditions
- Parkinson's Disease
- Keywords
- EARLY-STAGE, IDIOPATHIC PARKINSON'S DISEASE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Not posted in the source record
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 trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD.
Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.
The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early-stage, idiopathic Parkinson's disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SPM 962 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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
UCB Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPM 962 in people with Parkinson's Disease, run by UCB Pharma at 1 site in Germany.
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 0 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 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 25 Sep 2014.