Parkinson's DiseaseCALM-PD CohortNCT00804479
The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)
An observational study of Parkinson's Disease, run by University of Rochester at 1 site in United States.
Trial summary
To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2004
- 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: Available 301 subjects enrolled in CALM-PD
Who may be able to join
- Available 301 subjects enrolled in the CALM-PD study.
Who cannot join
- Those not enrolled in the CALM-PD study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.
To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.
- Conditions
- Parkinson's Disease
- Being tested
- No intervention.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England.
Measured: 8 years from date randomized in CALM study
Secondary outcomes (1)
Our secondary specific aim is to develop and estimate a structural model that will allow us to uncover the causal pathways through which treatments effect outcomes.
Measured: 8 years from randomization of CALM-PD study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJan 2002
- Primary completionMar 2004
- Study completionMar 2004
Why it stopped: Funding for the CALM-PD Cohort Study was terminated by sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia Corp. (Peapack, NJ), Boehringer Ingelheim
- Responsible party
- Principal investigator, Robert Holloway, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804479
- Sponsor's protocol ID
- PPXAPD-0072-138
- Other IDs
- RSRB #09283
- Acronym
- CALM-PD Cohort
- Status last verified
- Jan 2016
- First submitted
- 4 Dec 2008
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Parkinson Study Group CALM Cohort Investigators. Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol. 2009 May;66(5):563-70. doi: 10.1001/archneur.66.1.nct90001.
PubMed 19433655
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.
- ClinicalTrials.gov ID
- NCT00804479
- Acronym / sponsor ID
- CALM-PD Cohort / PPXAPD-0072-138
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding for the CALM-PD Cohort Study was terminated by sponsor.
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Pharmacia Corp. (Peapack, NJ), Boehringer Ingelheim
- Study start
- Jan 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 8 Dec 2008 (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.
To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Other: No intervention.Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Available 301 subjects enrolled in CALM-PD
Key inclusion criteria (1 listed)
- Available 301 subjects enrolled in the CALM-PD study.
Key exclusion criteria (1 listed)
- Those not enrolled in the CALM-PD study.
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 |
|---|---|---|
| No intervention. | Other | no treatment |
Primary outcome
We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England.
Time frame: 8 years from date randomized in CALM study
1 secondary outcome
Our secondary specific aim is to develop and estimate a structural model that will allow us to uncover the causal pathways through which treatments effect outcomes.
Time frame: 8 years from randomization of CALM-PD study
Results and safety
The study was stopped early (reason given: Funding for the CALM-PD Cohort Study was terminated by sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 19433655Parkinson Study Group CALM Cohort Investigators. Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol. 2009 May;66(5):563-70. doi: 10.1001/archneur.66.1.nct90001.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University of Rochester at 1 site in United States.
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: stopped early, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Funding for the CALM-PD Cohort Study was terminated by sponsor.). 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?
We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England. (time frame: 8 years from date randomized in CALM study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804479, which also lists 1 linked publication.
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 Jan 2016.