Idiopathic Parkinson's DiseasePhase 4SEWOPNCT00125567
Stalevo in Early Wearing-Off Patients
A Phase 4 study testing Stalevo (levodopa/carbidopa/entacapone) and Levodopa/carbidopa in people with Idiopathic Parkinson's Disease, run by Orion Corporation, Orion Pharma at 19 sites in 6 countries.
Trial summary
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Stalevo (levodopa/carbidopa/entacapone) and Levodopa/carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Aug 2005to Mar 2009
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
- Unchanged antiparkinsonian medication for 6 weeks prior to baseline
Who cannot join
- Secondary or atypical parkinsonism
- Patients with daily unpredictable OFF periods or painful dyskinesia
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
United Kingdom6 sites
Frenchay Hospital
Bristol, BS16 1LE
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Movement Disorder Services
Chertsey, Surrey, KT16 0QA
Leigh Infirmary
Leigh, WN7 1HS
Glan Clwyd Hospital
Rhyl, Wales, CF14 4XW
Southampton General Hospital
Southampton, SO16 6YD
Germany5 sites
Parkinson Klinik Bad Nauheim
Bad Nauheim, 61231 Bad Nauheim
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, 97616 Bad Neustadt
Neurologische Klinik der Universitat Dusseldorf
Düsseldorf, 40225 Duesseldorf
Allgemeines Krankenhaus Harburg
Hamburg, 21075 Hamburg
Praxis Drs Lang, Krauss, Schreiber
Ulm, 89073 Ulm
Denmark3 sites
Aalborg Hospital
Aalborg, DK-9000 Aalborg
Bispebjerg Hospital
Copenhagen
Århus Kommunehospital
Nørrebrogade 44, 8000
Finland2 sites
South Karelia Central Hospital
Lappeenranta
Tampere University Hospital
Tampere, 33521 Tampere
Sweden2 sites
Universitetssjukhuset MAS
Malmö, SE-205 02
Läkarhuset Vällingby
Vällingby, SE-162 68
About this study
Official title: Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Stalevo (levodopa/carbidopa/entacapone), Levodopa/carbidopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stalevo (levodopa/carbidopa/entacapone)Drug
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Levodopa/carbidopaDrug
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stalevo (levodopa/carbidopa/entacapone) Receives: Drug: Stalevo (levodopa/carbidopa/entacapone) |
| 2 | Active comparator | Levodopa/carbidopa Receives: Drug: Levodopa/carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Measured: Up to 2 years of treatment
Secondary outcomes (4)
Unified Parkinson's Disease Rating Scale
Measured: Up to 2 years of treatment
Clinical Global Impression of Change (investigator)
Measured: Up to 2 years of treatment
Parkinson's Disease Questionnaire (PDQ-39)
Measured: Up to 2 years of treatment
Work Impairment Questionnaire
Measured: Up to 2 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Wighton, BSc (Hons), Study director, Orion Corporation, Orion PharmaBhadravati SD Sastry, FRCP, Principal investigator, University Hospital of Wales and Rookwood Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125567
- Sponsor's protocol ID
- 2939111
- Other IDs
- EudraCT number: 2004-005234-39
- Acronym
- SEWOP
- Status last verified
- Jun 2009
- First submitted
- 29 Jul 2005
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off
- ClinicalTrials.gov ID
- NCT00125567
- Acronym / sponsor ID
- SEWOP / 2939111
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Aug 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 purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Stalevo (levodopa/carbidopa/entacapone)Stalevo (levodopa/carbidopa/entacapone) |
| 2 | Active comparator | Drug: Levodopa/carbidopaLevodopa/carbidopa |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's disease
- Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
- Unchanged antiparkinsonian medication for 6 weeks prior to baseline
Key exclusion criteria (2 listed)
- Secondary or atypical parkinsonism
- Patients with daily unpredictable OFF periods or painful dyskinesia
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 |
|---|---|---|
| Stalevo (levodopa/carbidopa/entacapone)Oral, 50-150 mg levodopa four times daily, for up to 2 years | Drug | 1 |
| Levodopa/carbidopaOral capsules, 50-150 mg levodopa four times daily, for up to 2 years | Drug | 2 |
Primary outcome
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Time frame: Up to 2 years of treatment
4 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: Up to 2 years of treatment
Clinical Global Impression of Change (investigator)
Time frame: Up to 2 years of treatment
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Up to 2 years of treatment
Work Impairment Questionnaire
Time frame: Up to 2 years of treatment
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 22 Jun 2009.
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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.
Andrew Wighton, BSc (Hons) study director
Orion Corporation, Orion Pharma
Bhadravati SD Sastry, FRCP principal investigator
University Hospital of Wales and Rookwood Hospital
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stalevo (levodopa/carbidopa/entacapone) and Levodopa/carbidopa in people with Idiopathic Parkinson's Disease, run by Orion Corporation, Orion Pharma at 19 sites in 6 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 3 inclusion and 2 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 22 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Germany, Denmark, Finland, Sweden and 1 more country. 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?
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms (time frame: Up to 2 years of treatment). 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 22 Jun 2009.