Parkinson's DiseaseNCT00203008
A Survey Study to See if Patients Diagnosed With Parkinson's Disease Have Higher Incidence of Melanoma
An observational study of Parkinson's Disease and Malignant Melanoma, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Malignant Melanoma
- How many people
- 2,106 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2003
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients known to have Parkinson's Disease will be invited to join the study by their treating physicians as long as they are not taking investigational product.
Who may be able to join
- Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment
Who cannot join
- unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product
About this study
Official title: A Survey to Assess the Incidence and Characteristics of Melanoma in Parkinson's Disease Patients
Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.
- Conditions
- Parkinson's Disease, Malignant Melanoma
- Medical subject headings
- Parkinson Disease, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational procedure | Patients will be examined and any suspicious skin abnormalities will be biopsied |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Study completionSep 2003
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
- Observational
- Enrolment
- 2,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruce Schwartz, Ph.D., Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203008
- Sponsor's protocol ID
- EP002
- Status last verified
- Oct 2010
- First submitted
- 13 Sep 2005
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey to Assess the Incidence and Characteristics of Melanoma in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00203008
- Acronym / sponsor ID
- EP002
- Conditions
- Parkinson's Disease, Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,106 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Sep 2003 (actual)
- First posted
- 20 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.
Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational procedure | – | –Patients will be examined and any suspicious skin abnormalities will be biopsied |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients known to have Parkinson's Disease will be invited to join the study by their treating physicians as long as they are not taking investigational product.
Key inclusion criteria (1 listed)
- Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment
Key exclusion criteria (1 listed)
- unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Oct 2010.
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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.
Bruce Schwartz, Ph.D. study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Malignant Melanoma, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 1 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 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 18 Oct 2010.