IDIOPATHIC PARKINSON'S DISEASEPhase 3NCT00243945
A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease
A Phase 3 study testing Rotigotine in people with IDIOPATHIC PARKINSON'S DISEASE, run by UCB Pharma at 1 site in Germany.
Trial summary
The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD. Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDIOPATHIC PARKINSON'S DISEASE
- What is being tested?
- Rotigotine
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2004to Jul 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
- Idiopathic Parkinson's disease
Who cannot join
- Subject has previously participated in a trial with rotigotine.
- Subject has participated in another trial of an investigational drug within the last 28 days or is currently participating in another trial of an investigational drug.
- Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment at an adequate dose due to lack of efficacy as assessed by the investigator.
- Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline.
- Subject is receiving therapy with controlled-release levodopa within 28 days prior to baseline or is receiving therapy with tolcapone.
- Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Visit 2: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (including atypical), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
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- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to baseline.
- Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes).
- Subject has a history of atopic eczema and/or active skin disease, such as atopic eczema.
- Presence of dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
- Subject is receiving CNS therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to baseline and is likely to remain stable for the duration of the trial.
- Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment.
- Subject has neoplastic disease requiring therapy within 12 months prior to enrollment.
- Presence of clinically relevant hepatic dysfunction.
- Presence of clinically relevant renal dysfunction.
- Evidence of clinically relevant cardiovascular disorders.
- Subject has a QTcB interval of ³500msec at Screening or Baseline (Visit 1 or 2; repeated measurements within 1 hour).
- Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- Subject has clinically significant laboratory results that, in the opinion of the investigator, would make the subject unsuitable for entry into the trial.
- Subject is pregnant or nursing, or is of child bearing potential but (i) not surgically sterile, or, (ii) not using adequate birth control methods (including at least one barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least two years post menopausal.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial.
- Subject has a known hypersensitivity to any components of the trial medication stated in this protocol.
- Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye movement (REM) behavior disorder, restless legs syndrome, or periodic limb movement disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD.
Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study.
The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed
- Conditions
- IDIOPATHIC PARKINSON'S DISEASE
- Being tested
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance; Sleep disorders; Clinical Global Impression; Patient Global Impression; Safety & Tolerability
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 startDec 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IDIOPATHIC 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
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
- NCT00243945
- Sponsor's protocol ID
- SP0826
- Other IDs
- 2004-002598-21, 2004
- Status last verified
- Sep 2009
- First submitted
- 24 Oct 2005
- Last updated
- 25 Sep 2014
- Results posted
- No
Publications
Giladi N, Fichtner A, Poewe W, Boroojerdi B. Rotigotine transdermal system for control of early morning motor impairment and sleep disturbances in patients with Parkinson's disease. J Neural Transm (Vienna). 2010 Dec;117(12):1395-9. doi: 10.1007/s00702-010-0506-4. Epub 2010 Nov 16.
PubMed 21080009
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 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00243945
- Acronym / sponsor ID
- SP0826
- Conditions
- IDIOPATHIC PARKINSON'S DISEASE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 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 assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD.
Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study.
The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic Parkinson's disease
Key exclusion criteria (23 listed)
- Subject has previously participated in a trial with rotigotine.
- Subject has participated in another trial of an investigational drug within the last 28 days or is currently participating in another trial of an investigational drug.
- Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment at an adequate dose due to lack of efficacy as assessed by the investigator.
- Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline.
- Subject is receiving therapy with controlled-release levodopa within 28 days prior to baseline or is receiving therapy with tolcapone.
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 |
|---|---|---|
| Rotigotine | Drug | – |
Primary outcome
Motor performance; Sleep disorders; Clinical Global Impression; Patient Global Impression; Safety & Tolerability
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.
- Results publication: PubMed 21080009Giladi N, Fichtner A, Poewe W, Boroojerdi B. Rotigotine transdermal system for control of early morning motor impairment and sleep disturbances in patients with Parkinson's disease. J Neural Transm (Vienna). 2010 Dec;117(12):1395-9. doi: 10.1007/s00702-010-0506-4. Epub 2010 Nov 16.
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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 Rotigotine in people with IDIOPATHIC 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 23 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.
What does the primary outcome measure?
Motor performance; Sleep disorders; Clinical Global Impression; Patient Global Impression; Safety & Tolerability. 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 NCT00243945, 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 25 Sep 2014.