PharmacokineticsPhase 1NCT00693862
Pharmacokinetic Study With Repeated Doses of Stalevo
A Phase 1 study testing levodopa, carbidopa, entacapone and levodopa, carbidopa in people with Pharmacokinetics, run by Orion Corporation, Orion Pharma at 3 sites in Finland.
Trial summary
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen. Read more about this study
- Who is it for?
- Ages 30 to 72 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- levodopa, carbidopa, entacapone and levodopa, carbidopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesFinland
- Study dates
- Dec 2006to May 2008
- Phase
- Phase 1
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained
- Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms.
- Hoehn and Yahr stage 1-2.5 performed during the "ON" state.
- Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg.
- Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period.
- Age within 30-72 years, inclusive.
Who cannot join
- Secondary or atypical parkinsonism.
- Patients with moderate to marked wearing-off symptoms or any unpredictable "OFF"-periods.
- Patients with treatment-related peak-dose dyskinesia.
- Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks.
- Use of any iron preparations or other chelating agents.
- Patients with a history of a laboratory abnormality consistent with, or clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness, which may influence the outcome of the study.
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- History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
- Any abnormalities in laboratory values, vital signs or electrocardiogram (ECG) with clinical relevance.
- Patients using any antiparkinsonian drugs for rescue medication (including soluble levodopa formulations).
- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
- Known hypersensitivity to active substances or to any of the excipients of the study drugs.
- Participation in other drug studies within 60 days prior to study entry
- Unsuitable veins for repeated venopuncture.
- Blood donation or loss of significant amount of blood within 60 days prior to the screening.
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
NEURO
Helsinki, 00250
Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
Kuopio, 70211
Turku University Hospital
Turku, 20521
About this study
Official title: Levodopa Concentration Profile After Repeated Doses of Stalevo
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.
- Conditions
- Pharmacokinetics
- Being tested
- levodopa, carbidopa, entacapone, levodopa, carbidopa
- Keywords
- Focus of the study is pharmacokinetics of the study drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa, carbidopa, entacaponeDrug
levodopa, carbidopaDrug
| Study group | Role | What they receive |
|---|---|---|
| Stalevo | Experimental | Not described Receives: Drug: levodopa, carbidopa, entacapone |
| levodopa/carbidopa | Active comparator | Not described Receives: Drug: levodopa, carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: Blood samples collected frequently on day 4 of both periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jutta Hänninen, M.Sc., Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693862
- Sponsor's protocol ID
- 2939115
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 9 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levodopa Concentration Profile After Repeated Doses of Stalevo
- ClinicalTrials.gov ID
- NCT00693862
- Acronym / sponsor ID
- 2939115
- Conditions
- Pharmacokinetics
- Keywords
- Focus of the study is pharmacokinetics of the study drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Jun 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.
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stalevo | Experimental | Drug: levodopa, carbidopa, entacapone |
| levodopa/carbidopa | Active comparator | Drug: levodopa, carbidopa |
Who may qualify
- Ages
- 30 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained
- Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms.
- Hoehn and Yahr stage 1-2.5 performed during the "ON" state.
- Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg.
- Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period.
Key exclusion criteria (14 listed)
- Secondary or atypical parkinsonism.
- Patients with moderate to marked wearing-off symptoms or any unpredictable "OFF"-periods.
- Patients with treatment-related peak-dose dyskinesia.
- Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks.
- Use of any iron preparations or other chelating agents.
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, carbidopa, entacapone | Drug | Stalevo |
| levodopa, carbidopa | Drug | levodopa/carbidopa |
Primary outcome
Pharmacokinetics
Time frame: Blood samples collected frequently on day 4 of both periods
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 9 Jun 2008.
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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.
Jutta Hänninen, M.Sc. study director
Orion Corporation, Orion Pharma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing levodopa, carbidopa, entacapone and levodopa, carbidopa in people with Pharmacokinetics, run by Orion Corporation, Orion Pharma at 3 sites 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 6 inclusion and 14 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 9 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics (time frame: Blood samples collected frequently on day 4 of both periods). 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 9 Jun 2008.