Parkinson's DiseasePhase 4NCT00143026
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States
A Phase 4 study testing carbidopa, levodopa, entacapone in people with Parkinson's Disease, run by Novartis at 18 sites in 4 countries.
Trial summary
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- carbidopa, levodopa, entacapone
- How many people
- 184 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jul 2005to Jun 2006
- 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
- Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
- Motor functions must be regarded as non-disabling by the patient
Who cannot join
- History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
- History of dyskinesia
- Previous or current use of entacapone or tolcapone
- Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
- Subjects taking levodopa/DDCI controlled release or extended release formulations
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Australia9 sites
Royal Adelaide Hospital
Adelaide
Watkins Medical Center
Brisbane
Central Coast Neuroscience Research
Gosford
Heidelberg Repatriation Hospital
Melbourne
Monash Medical Centre
Melbourne
Sir Charles Gairdner Hospital
Perth
Concord Hospital
Sydney
Southern Neurology, St. George Private Hospital
Sydney
Westmead Hospital
Sydney
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok
Maharaj Nakorn Chiangmai Hospital
Bangkok
Pharmongkutklao Army Hospital
Bangkok
Siriraj Hospital
Bangkok
Taiwan3 sites
Chang Gung Memorial Hospital
Linkou District
Kaohsiung Medical University, Chung-Ho Memorial Hospital
Linkou District
National Taiwan University Hospital
Linkou District
Philippines2 sites
St. Luke's Medical Centre
Manila
University of Santo Tomas Hospital
Manila
About this study
Official title: Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
Read the detailed description
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.
- Conditions
- Parkinson's Disease
- Being tested
- carbidopa, levodopa, entacapone
- Keywords
- Parkinson's disease, levodopa, motor fluctuations
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbidopa, levodopa, entacaponeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
Secondary outcomes (3)
Symptom control change from baseline
Change from baseline in number of wearing-off symptoms
Change from baseline in proportion of patients experiencing wearing-off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143026
- Sponsor's protocol ID
- CELC200A2406
- Status last verified
- Mar 2017
- First submitted
- 31 Aug 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00143026
- Acronym / sponsor ID
- CELC200A2406
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, levodopa, motor fluctuations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 2 Sep 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.
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
Detailed description
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
- Motor functions must be regarded as non-disabling by the patient
Key exclusion criteria (5 listed)
- History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
- History of dyskinesia
- Previous or current use of entacapone or tolcapone
- Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
- Subjects taking levodopa/DDCI controlled release or extended release formulations
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 |
|---|---|---|
| carbidopa, levodopa, entacapone | Drug | – |
Primary outcome
Quality of life assessment
3 secondary outcomes
Symptom control change from baseline
Change from baseline in number of wearing-off symptoms
Change from baseline in proportion of patients experiencing wearing-off
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 29 Mar 2017.
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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.
Novartis Pharmaceuticals study chair
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbidopa, levodopa, entacapone in people with Parkinson's Disease, run by Novartis at 18 sites in 4 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 2 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia, Thailand, Taiwan, Philippines. 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?
Quality of life assessment. 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 29 Mar 2017.