Parkinson DiseasePhase 4NCT00174239
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
A Phase 4 study testing cabergoline in people with Parkinson Disease, run by Pfizer at 14 sites in 3 countries.
Trial summary
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- cabergoline
- How many people
- 220 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jul 2004to Sep 2005
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson Disease
- Must be experiencing sleep akinesia
Who cannot join
- Current treatment with other dopamine agonists
- Nocturnal hallucinations
- Dementia
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Italy8 sites
Pfizer Investigational Site
Bologna
Pfizer Investigational Site
Bolzano
Pfizer Investigational Site
Loc. Camerelle - Pozzilli, IS
Pfizer Investigational Site
Naples
Pfizer Investigational Site
Padova
Pfizer Investigational Site
Palermo
Pfizer Investigational Site
Roma
Pfizer Investigational Site
Vittoria, Ragusa
Spain4 sites
Pfizer Investigational Site
Barcelona, Barcelona
Pfizer Investigational Site
Madrid, Madrid
Pfizer Investigational Site
Oviedo, Principality of Asturias
Pfizer Investigational Site
Seville, Sevilla
Australia2 sites
Pfizer Investigational Site
Brisbane, Queensland
Pfizer Investigational Site
Westmead, New South Wales
About this study
Official title: A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.
Read the detailed description
The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
- Conditions
- Parkinson Disease
- Being tested
- cabergoline, controlled-release 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.
cabergolineDrug
controlled-release levodopa / carbidopaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PDSS, UPDRS
Secondary outcomes (1)
CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2004
- Study completionSep 2005
Why it stopped: See Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 220 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174239
- Sponsor's protocol ID
- A7231001
- Status last verified
- May 2007
- First submitted
- 9 Sep 2005
- Last updated
- 25 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.
- ClinicalTrials.gov ID
- NCT00174239
- Acronym / sponsor ID
- A7231001
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description for termination reason.
- Enrolment
- 220 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 15 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.
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.
Detailed description
The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic Parkinson Disease
- Must be experiencing sleep akinesia
Key exclusion criteria (3 listed)
- Current treatment with other dopamine agonists
- Nocturnal hallucinations
- Dementia
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 |
|---|---|---|
| cabergoline | Drug | – |
| controlled-release levodopa / carbidopa | Drug | – |
Primary outcome
PDSS, UPDRS
1 secondary outcome
CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Results and safety
The study was stopped early (reason given: See Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2007.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
14 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 cabergoline in people with Parkinson Disease, run by Pfizer at 14 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Spain, Australia. 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 was stopped early (reason given: See Detailed Description for termination reason.). Results are not available in the source record.
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?
PDSS, UPDRS. 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 25 May 2007.