Parkinson's DiseasePhase 4NCT00914134
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
A Phase 4 study testing Levodopa infusion in people with Parkinson's Disease, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Levodopa infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2009to Jan 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
- Positive response to levodopa
- Motor fluctuations that cannot be adequately controlled with oral medication
- No signs or symptoms of cerebellar dysfunction or vascular parkinsonism
Who cannot join
- Severe cognitive symptoms
- Glaucoma
- Severe arrythmias
- Severe asthma or COPD
- Heart, liver or kidney failure
- No significant vascular lesions in brain MRI imaging.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Department of Neurology
Helsinki, 00250
About this study
Official title: Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease
The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.
Read the detailed description
Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.
- Conditions
- Parkinson's Disease
- Being tested
- Levodopa infusion
- Keywords
- Parkinson's disease, Autonomic nervous system, Levodopa infusion
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa infusionDrug
Also called Duodopa
Naso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose.
| Study group | Role | What they receive |
|---|---|---|
| Levodopa Infusion | Experimental | Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication. Receives: Drug: Levodopa infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic blood pressure change
Measured: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started
Secondary outcomes (3)
Sweating measured by evaporimeter
Measured: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started
Autonomic nervous system symptoms questionnaire (NMSS)
Measured: Before levodopa infusion and 2 months after levodopa infusion was started
Quality of life questionnaire (PDQ-39)
Measured: Before levodopa infusion and 2 months after levodopa infusion was started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionJan 2011
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Eero Pekkonen, MD, PhD, Study director, Helsinki University Central Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914134
- Sponsor's protocol ID
- PDAUT2009
- Status last verified
- Feb 2011
- First submitted
- 1 Jun 2009
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00914134
- Acronym / sponsor ID
- PDAUT2009
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Autonomic nervous system, Levodopa infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Jun 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 aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.
Detailed description
Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levodopa Infusion | Experimental | Drug: Levodopa infusionPatients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
- Positive response to levodopa
- Motor fluctuations that cannot be adequately controlled with oral medication
- No signs or symptoms of cerebellar dysfunction or vascular parkinsonism
Key exclusion criteria (6 listed)
- Severe cognitive symptoms
- Glaucoma
- Severe arrythmias
- Severe asthma or COPD
- Heart, liver or kidney failure
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 infusionAlso: DuodopaNaso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose. | Drug | Levodopa Infusion |
Primary outcome
Orthostatic blood pressure change
Time frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started
3 secondary outcomes
Sweating measured by evaporimeter
Time frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started
Autonomic nervous system symptoms questionnaire (NMSS)
Time frame: Before levodopa infusion and 2 months after levodopa infusion was started
Quality of life questionnaire (PDQ-39)
Time frame: Before levodopa infusion and 2 months after levodopa infusion was started
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 24 Feb 2011.
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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.
Eero Pekkonen, MD, PhD study director
Helsinki University Central Hospital, Department of Neurology
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 infusion in people with Parkinson's Disease, run by University of Helsinki at 1 site in Finland.
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 4 inclusion and 6 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 24 Feb 2011. 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 Finland. 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?
Orthostatic blood pressure change (time frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started). 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 24 Feb 2011; AzTrials last refreshed its copy on 8 Nov 2026.