Parkinson's DiseasePhase 4NCT00153972
Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease
A Phase 4 study testing Cabergoline and Levodopa in people with Parkinson's Disease, run by Technische Universität Dresden at 2 sites in Germany.
Trial summary
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Cabergoline and Levodopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2005to Jan 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early (de novo) Parkinson's disease (Hoen \& Yahr I and II), according to the UK brain bank criteria
Who cannot join
- Current or past dopaminergic treatment
- Atypical parkinsonian syndromes
- Treatment with neuroleptics (present and past)
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Neurology at the Technical University of Dresden
Dresden, Saxony, 01307
Department of Nuclear Medicine at the Technical University of Dresden
Dresden, Saxony, 01307
About this study
Official title: Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa.
Read more
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications.
Read the detailed description
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum. The specific aim of the study was to estimate normal ranges and test-retest measures for various parameters characterising dopamine metabolism from a prolonged 18F-dopa positron emission tomography (PET) measurement using a reference tissue model and compare their value for the detection of early PD.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications. The specific aim is to evaluate the effects of levodopa and the dopamine D2 agonist cabergoline on striatal dopamine turnover estimated as the inverse of the effective dopamine distribution volume ratio (EDVR) measured by 18F-dopa PET in de-novo PD.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa. This study is an investigator-blinded, randomized mono-center controlled phase IV study.
The main inclusion criteria are:
- Early (de novo) Parkinson's disease (Hoen \& Yahr I and II), according to the UK brain bank criteria
The main exclusion criteria are:
- Current or past dopaminergic treatment
- Atypical parkinsonian syndromes
- Treatment with neuroleptics (present and past)
Methods:
- Fluoro-dopa-PET for measuring the dopamine turnover rate
- clinical investigations including parkinsonian rating scales (e.g. UPDRS, PDQ-39, etc.)
- olfactory tests
Study medication:
- Cabergoline (1 to 3 mg once per day)
- Levodopa/carbidopa (50 until 300 mg levodopa per day in one to three dosages)
- Conditions
- Parkinson's Disease
- Being tested
- Cabergoline, Levodopa
- Keywords
- Parkinson's disease, Fluoro-Dopa-PET, Dopamine agonists, Cabergoline, Surrogate marker, Dopamine turnover
- 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
LevodopaDrug
| Study group | Role | What they receive |
|---|---|---|
| Levodopa | Active comparator | Levodopa 300 mg per day orally. Receives: Drug: Cabergoline; Drug: Levodopa |
| Cabergoline | Active comparator | Cabergoline 3 mg per day orally. Receives: Drug: Cabergoline; Drug: Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
Secondary outcomes (1)
Changes of clinical outcome measured with parkinsonian rating scales (UPDRS, PDQ-39, ESS, olfactory function)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionJan 2009
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 Technische Universität DresdenThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Alexander Storch, Technische Universität Dresden
- Investigators
- Heinz Reichmann, MD, Principal investigator, Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153972
- Sponsor's protocol ID
- 91052003
- Status last verified
- Dec 2012
- First submitted
- 7 Sep 2005
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oehme L, Perick M, Beuthien-Baumann B, Wolz M, Storch A, Lohle M, Herting B, Langner J, van den Hoff J, Reichmann H, Kotzerke J. Comparison of dopamine turnover, dopamine influx constant and activity ratio of striatum and occipital brain with (1)(8)F-dopa brain PET in normal controls and patients with Parkinson's disease. Eur J Nucl Med Mol Imaging. 2011 Aug;38(8):1550-9. doi: 10.1007/s00259-011-1819-8. Epub 2011 May 7.
PubMed 21553090
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Turnover Rate Measured With F-Dopa-PET as Surrogate Parameter for Diagnosis and Progression Analysis of Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00153972
- Acronym / sponsor ID
- 91052003
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Fluoro-Dopa-PET, Dopamine agonists, Cabergoline, Surrogate marker, Dopamine turnover
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 12 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 is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa.
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications.
Detailed description
The study is designed to measure the difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
The hypothesis for this study is that the dopamine turnover rate is a more sensitive marker for the early diagnosis of Parkinson's disease compared to the standard Fluoro-Dopa-PET measuring only the Fluoro-Dopa uptake into the striatum. The specific aim of the study was to estimate normal ranges and test-retest measures for various parameters characterising dopamine metabolism from a prolonged 18F-dopa positron emission tomography (PET) measurement using a reference tissue model and compare their value for the detection of early PD.
For the interventional part of the study, the hypothesis is that levodopa has larger effects on striatal dopamine turnover compared to dopamine agonists by providing more dopamine precursor. Enhancement of compensatory mechanisms for dopamine loss in early PD such as increased dopamine turnover could have several beneficial implications such as improvement or prolongation of symptomatic treatment responses, but might also produce therapeutic problems such as the development of levodopa-induced motor complications. The specific aim is to evaluate the effects of levodopa and the dopamine D2 agonist cabergoline on striatal dopamine turnover estimated as the inverse of the effective dopamine distribution volume ratio (EDVR) measured by 18F-dopa PET in de-novo PD.
The study protocol includes an initial Fluoro-Dopa-PET scan before treatment and after three months double-blind treatment with cabergoline or levodopa. This study is an investigator-blinded, randomized mono-center controlled phase IV study.
The main inclusion criteria are:
- Early (de novo) Parkinson's disease (Hoen \& Yahr I and II), according to the UK brain bank criteria
The main exclusion criteria are:
- Current or past dopaminergic treatment
- Atypical parkinsonian syndromes
- Treatment with neuroleptics (present and past)
Methods:
- Fluoro-dopa-PET for measuring the dopamine turnover rate
- clinical investigations including parkinsonian rating scales (e.g. UPDRS, PDQ-39, etc.)
- olfactory tests
Study medication:
- Cabergoline (1 to 3 mg once per day)
- Levodopa/carbidopa (50 until 300 mg levodopa per day in one to three dosages)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levodopa | Active comparator | Drug: Cabergoline, Drug: LevodopaLevodopa 300 mg per day orally. |
| Cabergoline | Active comparator | Drug: Cabergoline, Drug: LevodopaCabergoline 3 mg per day orally. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early (de novo) Parkinson's disease (Hoen \& Yahr I and II), according to the UK brain bank criteria
Key exclusion criteria (4 listed)
- Current or past dopaminergic treatment
- Atypical parkinsonian syndromes
- Treatment with neuroleptics (present and past)
- Pregnancy
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 | Cabergoline, Levodopa |
| Levodopa | Drug | Cabergoline, Levodopa |
Primary outcome
Difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.
1 secondary outcome
Changes of clinical outcome measured with parkinsonian rating scales (UPDRS, PDQ-39, ESS, olfactory function)
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 Dec 2012.
- Results publication: PubMed 21553090Oehme L, Perick M, Beuthien-Baumann B, Wolz M, Storch A, Lohle M, Herting B, Langner J, van den Hoff J, Reichmann H, Kotzerke J. Comparison of dopamine turnover, dopamine influx constant and activity ratio of striatum and occipital brain with (1)(8)F-dopa brain PET in normal controls and patients with Parkinson's disease. Eur J Nucl Med Mol Imaging. 2011 Aug;38(8):1550-9. doi: 10.1007/s00259-011-1819-8. Epub 2011 May 7.
- Homepage of principle locationLink 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.
Heinz Reichmann, MD principal investigator
Technical University of Dresden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabergoline and Levodopa in people with Parkinson's Disease, run by Technische Universität Dresden at 2 sites in Germany.
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 4 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 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Difference of dopamine turnover rate measured by Fluoro-Dopa-PET in the putamen between patients with Parkinson's disease treated with cabergoline and levodopa for 3 months.. 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 NCT00153972, 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 18 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.