Parkinson's DiseasePhase 1NEWSTANCT01070628
Levodopa Concentration Profile With Stalevo 75/125 mg
A Phase 1 study testing Stalevo (levodopa/ carbidopa/ entacapone) and Sinemet (levodopa/carbidopa) in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Stalevo (levodopa/ carbidopa/ entacapone) and Sinemet (levodopa/carbidopa)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2009to Feb 2010
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males or females, 18-70 years of age inclusive.
- Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2).
- Weight at least 50.0 kg.
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Who cannot join
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed.
- Intake of any medication that could affect the outcome of the study.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
- Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing:
- decrease of ≥ 20 mmHg for systolic BP
Show all 20Show fewer
- decrease of ≥ 10 mmHg for diastolic BP.
- Strong tendency to motion sickness.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- Pregnant or lactating females.
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam/Vagitorie, condom on male partner). Double methods (mentioned above) of contraception is needed during the study. (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
- Recent or current (suspected) drug abuse or positive result in the drug abuse test.
- Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent]).
- Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the stay at the study centre.
- Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages while at the study centre.
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
- Administration of another investigational treatment within 90 days prior to the first study treatment administration.
- Unsuitable veins for repeated venipuncture or for cannulation.
- Predictable poor compliance or inability to communicate well with the study centre personnel.
- Inability to participate in all treatment periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups
The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.
- Conditions
- Parkinson's Disease
- Being tested
- Stalevo (levodopa/ carbidopa/ entacapone), Sinemet (levodopa/carbidopa)
- Keywords
- Pharmacokinetic
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stalevo (levodopa/ carbidopa/ entacapone)Drug
Also called Stalevo
150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
Sinemet (levodopa/carbidopa)Drug
Also called Sinemet
150 or 100 mg levodopa q.i.d. in 3.5 hr interval
| Study group | Role | What they receive |
|---|---|---|
| Stalevo (levodopa/carbidopa/entacapone) | Experimental | 125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively.
150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively. Receives: Drug: Stalevo (levodopa/ carbidopa/ entacapone) |
| Sinemet (levodopa/carbidopa) | Active comparator | 150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively Receives: Drug: Sinemet (levodopa/carbidopa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day.
Measured: 2-11 weeks
Secondary outcomes (1)
Cmin, AUCo-tau
Measured: each subject 3 PK days between 1-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kimmo Ingman, Principal investigator, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070628
- Sponsor's protocol ID
- 2939131
- Acronym
- NEWSTA
- Status last verified
- Aug 2010
- First submitted
- 23 Nov 2009
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups
- ClinicalTrials.gov ID
- NCT01070628
- Acronym / sponsor ID
- NEWSTA / 2939131
- Conditions
- Parkinson's Disease
- Keywords
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Feb 2010 (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 confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stalevo (levodopa/carbidopa/entacapone) | Experimental | Drug: Stalevo (levodopa/ carbidopa/ entacapone)125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively. 150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively. |
| Sinemet (levodopa/carbidopa) | Active comparator | Drug: Sinemet (levodopa/carbidopa)150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males or females, 18-70 years of age inclusive.
- Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2).
- Weight at least 50.0 kg.
Key exclusion criteria (20 listed)
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed.
- Intake of any medication that could affect the outcome of the study.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
- Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing:
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 |
|---|---|---|
| Stalevo (levodopa/ carbidopa/ entacapone)Also: Stalevo150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval | Drug | Stalevo (levodopa/carbidopa/entacapone) |
| Sinemet (levodopa/carbidopa)Also: Sinemet150 or 100 mg levodopa q.i.d. in 3.5 hr interval | Drug | Sinemet (levodopa/carbidopa) |
Primary outcome
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day.
Time frame: 2-11 weeks
1 secondary outcome
Cmin, AUCo-tau
Time frame: each subject 3 PK days between 1-6 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 13 Aug 2010.
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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.
Kimmo Ingman principal investigator
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stalevo (levodopa/ carbidopa/ entacapone) and Sinemet (levodopa/carbidopa) in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma 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 6 inclusion and 20 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 13 Aug 2010. 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 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?
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day. (time frame: 2-11 weeks). 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 13 Aug 2010.