Parkinson's DiseasePhase 4SENSENCT00462007
Study to Evaluate Initiation of Stalevo in Early Wearing-off
A Phase 4 study testing Stalevo in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 20 sites in 3 countries.
Trial summary
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Stalevo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 4
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment
- Age >35 - years
- Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
- At least 1 symptom identified by WOQ-9
- Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)
Who cannot join
- Atypical or symptomatic Parkinson's disease
- Unpredictable OFF-periods
- Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
- Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
- Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Germany14 sites
Humboldt Universität Charité Neurologische Klinik
Berlin, 10098
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Bochum, 44791
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
Nervenarztpraxis Dr Alexander Nass
Cologne, 51069
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, 01307
Gemeinschaftspraxis für Neurologie & Psychiatrie
Erbach im Odenwald, 64711
Neurologische Praxis Dr Christine Schuster
Giessen, 35390
Universitätskrankenhaus Eppendorf
Hamburg, 20251
Paracelsus-Elena Klinik
Kassel, 34128
Alexianer-Krankenhaus
Krefeld, 47805
Universitätsklinikum Gießen und Marburg GmbH
Marburg, D-35039
Asklepios Fachklinikum Stadtroda
Stadtroda, 07646
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076
Neurologische Klinik der Universität Ulm
Ulm, 89081
Sweden3 sites
Länsjukhuset Ryhov, Geriatriska Kliniken
Jönköping, 55185
Nyköpings Lasarett, Ger/Rehabkliniken
Nyköping, 61185
Visby lasarett, Neurologmottagningen
Visby, 62184
United Kingdom3 sites
The Royal Bournemouth Hospital, Department of Medicines for the Elderly
Bournemouth, Dorset, BH7 7DW
Royal Sussex County Hospital, Neurology Department
Brighton, BN2 5BE
North Tyneside General Hospital, Department of Medicine
North Shields, Tyne and Wear, NE29 8NH
About this study
Official title: Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.
Read the detailed description
See 'Brief summary'.
- Conditions
- Parkinson's Disease
- Being tested
- Stalevo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StalevoDrug
Oral 3-4 daily doses for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stalevo Receives: Drug: Stalevo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Change (Patient)
Measured: 6 weeks
Secondary outcomes (1)
Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionDec 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang H. Oertel, Professor, Principal investigator, Universitätsklinikum Giessen und Marburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462007
- Sponsor's protocol ID
- 2939117
- Acronym
- SENSE
- Status last verified
- Apr 2015
- First submitted
- 17 Apr 2007
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00462007
- Acronym / sponsor ID
- SENSE / 2939117
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Apr 2007 (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.
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.
Detailed description
See 'Brief summary'.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: StalevoStalevo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment
- Age >35 - years
- Hoehn and Yahr stage 1-3 performed during the 'ON'-stage
- At least 1 symptom identified by WOQ-9
- Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa)
Key exclusion criteria (5 listed)
- Atypical or symptomatic Parkinson's disease
- Unpredictable OFF-periods
- Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed
- Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed.
- Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
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 |
|---|---|---|
| StalevoOral 3-4 daily doses for 6 weeks | Drug | 1 |
Primary outcome
Clinical Global Impression of Change (Patient)
Time frame: 6 weeks
1 secondary outcome
Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms
Time frame: 6 weeks
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 21 Apr 2015.
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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.
Wolfgang H. Oertel, Professor principal investigator
Universitätsklinikum Giessen und Marburg GmbH
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stalevo in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 20 sites in 3 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 5 inclusion and 5 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Sweden, United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical Global Impression of Change (Patient) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
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 21 Apr 2015.