Parkinson DiseasePhase 4DYSK-PD-2007NCT00888186
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
A Phase 4 study testing levodopa/carbidopa in people with Parkinson Disease and Dyskinesias, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease, Dyskinesias
- What is being tested?
- levodopa/carbidopa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2008to May 2008
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease
- Ongoing treatment with Duodopa
- Occurrence of dyskinesias, difficult to manage
- Age 30-90 years
- Hoehn \& Yahr stage 3-5 at worst
Who cannot join
- Treatment with dopamine agonist or glutamate antagonist
- Dementia
- Psychosis
- Treatment with typical neuroleptics
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.
Read the detailed description
By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.
- Conditions
- Parkinson Disease, Dyskinesias
- Being tested
- levodopa/carbidopa
- Keywords
- Dyskinesias, Duodenal levodopa infusion, Dose optimization, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa/carbidopaDrug
Also called Duodopa
intestinal gel, for continuous daytime infusion
| Study group | Role | What they receive |
|---|---|---|
| 1. Duodopa optimal dose | Active comparator | Not described Receives: Drug: levodopa/carbidopa |
| 2. Duodopa 20% too high dose | Experimental | Not described Receives: Drug: levodopa/carbidopa |
| 3. Duodopa 10% too low dose | Experimental | Not described Receives: Drug: levodopa/carbidopa |
| 4. Duodopa 20% too low dose | Experimental | Not described Receives: Drug: levodopa/carbidopa |
| 5. Duodopa 10% too high dose | Experimental | Not described Receives: Drug: levodopa/carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
Measured: 3 days
Secondary outcomes (1)
Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888186
- Sponsor's protocol ID
- DYSK-PD-2007
- Acronym
- DYSK-PD-2007
- Status last verified
- Apr 2009
- First submitted
- 24 Apr 2009
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyholm D, Nilsson Remahl AI, Dizdar N, Constantinescu R, Holmberg B, Jansson R, Aquilonius SM, Askmark H. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology. 2005 Jan 25;64(2):216-23. doi: 10.1212/01.WNL.0000149637.70961.4C.
PubMed 15668416
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
- ClinicalTrials.gov ID
- NCT00888186
- Acronym / sponsor ID
- DYSK-PD-2007 / DYSK-PD-2007
- Conditions
- Parkinson Disease, Dyskinesias
- Keywords
- Dyskinesias, Duodenal levodopa infusion, Dose optimization, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Apr 2009 (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 purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.
Detailed description
By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. Duodopa optimal dose | Active comparator | Drug: levodopa/carbidopa |
| 2. Duodopa 20% too high dose | Experimental | Drug: levodopa/carbidopa |
| 3. Duodopa 10% too low dose | Experimental | Drug: levodopa/carbidopa |
| 4. Duodopa 20% too low dose | Experimental | Drug: levodopa/carbidopa |
| 5. Duodopa 10% too high dose | Experimental | Drug: levodopa/carbidopa |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of idiopathic Parkinson's disease
- Ongoing treatment with Duodopa
- Occurrence of dyskinesias, difficult to manage
- Age 30-90 years
- Hoehn \& Yahr stage 3-5 at worst
Key exclusion criteria (4 listed)
- Treatment with dopamine agonist or glutamate antagonist
- Dementia
- Psychosis
- Treatment with typical neuroleptics
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 |
|---|---|---|
| levodopa/carbidopaAlso: Duodopaintestinal gel, for continuous daytime infusion | Drug | 1. Duodopa optimal dose, 2. Duodopa 20% too high dose, 3. Duodopa 10% too low dose, 4. Duodopa 20% too low dose, 5. Duodopa 10% too high dose |
Primary outcome
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
Time frame: 3 days
1 secondary outcome
Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
Time frame: 3 days
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 27 Apr 2009.
- Background: PubMed 15668416Nyholm D, Nilsson Remahl AI, Dizdar N, Constantinescu R, Holmberg B, Jansson R, Aquilonius SM, Askmark H. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology. 2005 Jan 25;64(2):216-23. doi: 10.1212/01.WNL.0000149637.70961.4C.
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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?
A Phase 4 study testing levodopa/carbidopa in people with Parkinson Disease and Dyskinesias, run by Uppsala University at 1 site in Sweden.
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 5 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 27 Apr 2009. 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 Sweden. 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?
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism (time frame: 3 days). 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 NCT00888186, 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 27 Apr 2009.