Parkinson's DiseasePhase 2PARTESTNCT01296464
Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens
A Phase 2 study testing Carbidopa in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 5 sites in 2 countries.
Trial summary
The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2011to Jul 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent (IC) obtained.
- Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose motor fluctuations
- Hoehn and Yahr stage 2-4 performed during the "ON" state.
- Duration of response between 1.5 and 4 hours (based on medical history) to the patient's first morning dose of levodopa/dopa decarboxylase inhibitor (DDCI) with or without entacapone.
- Treatment with 3-8 daily doses of levodopa/DDCI with or without entacapone with a total daily levodopa dose in the range of 300-1200 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed provided that it is included in the total of 3-8 daily doses of levodopa/DDCI mentioned above.
- Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian medication(dopamine agonists, monoamine oxidase [MAO] B inhibitor, amantadine and/or anticholinergics with approved doses), if any, for at least 6 weeks prior to the screening visit.
- Age of 30 years or above
Who cannot join
- Secondary or atypical parkinsonism.
- Use of tolcapone within 6 weeks prior to the first treatment period.
- Previous tolerability problems with entacapone or tolcapone.
- Concomitant treatment with apomorphine, MAO-A inhibitors or nonselective MAO inhibitors.
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception, an evening dose of an atypical antipsychotic is allowed.
- Use of any iron preparations.
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- Intensity of dyskinesias which would, in the opinion of the investigator, interfere with the interpretation of motor part (part III of the Unified Parkinson's Disease Rating Scale (UPDRS III) scoring during the levodopa challenge test.
- Currently active hallucinations.
- Severe orthostatic hypotension as judged by the investigator.
- Mini-Mental State Examination (MMSE) score < 26
- History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- Past or current treatment with deep brain stimulation (DBS) or other surgical treatment for PD.
- Treatment with levodopa or dopamine agonist infusion or injection
- Active malignancy, narrow-angle glaucoma or pheochromocytoma.
- Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part into the study.
- Alanine aminotransferase or aspartate aminotransferase > upper limit of normal at screening.
- Any other abnormal value of laboratory, vital signs or electrocardiogra (ECG) which would in the opinion of the investigator interfere with the interpretation of the study results or cause health risk for the subject if he/she takes part into the study.
- Female patients of childbearing potential (i.e. menstruating or less than 2 years postmenopausal) if they are not using proper contraception (hormonal contraception, intrauterine device [IUD] or surgical sterilisation, spermicidal foam in conjunction with condom on male partner).
- Patients with pre-planned elective surgery.
- Known hypersensitivity to active substances or to any of the excipients of the study drugs.
- Participation in a drug study within 60 days prior to entry to this study.
- Any other condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part into the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Finland3 sites
Kanta-Hämeen keskussairaala
Hämeenlinna, 13530
ODL Terveys Oy (ODL)
Oulu, 90100
Porin Lääkäritalo
Pori, 28100
Sweden2 sites
Länssjukhuset Ryhov, Medicin/Neurologmottagningen
Jönköping, SE-55185
Karolinska Universitetssjukhuset Solna, Neurologkliniken
Stockholm, SE-171 76
About this study
Official title: Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms
The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD.
Read the detailed description
This is a randomised, double-blind, 3-period crossover study comparing the effects of a single dose of two L/C/E treatment regimens (A and B) and standard L/C/E treatment regimen (Stalevo) on the duration of motor response in PD patients with wearing-off symptoms after the first morning dose of levodopa.
The study consists of a screening visit, 3 treatment visits and an end-of-study visit. Within 14 days of the screening visit, the patients will receive a single morning dose of study drug (either of the two L/C/E treatment regimens) or Stalevo. The order of the 3 treatment periods will be randomised according to a crossover design and the duration of each period is 2 days, followed by a wash-out period (1-9 days) during which the patients will be on their individual standard PD treatment.
Before each study day, patients will arrive at the study centre in the previous evening. The patients' own standard PD treatments will be discontinued at the latest by 22:00 to be continued after completion of the motor part (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III) next day. After completion of the UPDRS III, patients will return to their own standard PD treatments. Duration of the study will be 2 to 7 weeks per patient, depending on the length of the screening and wash-out periods.
- Conditions
- Parkinson's Disease
- Being tested
- Carbidopa
- Keywords
- Parkinson's Disease, Motor response, Wearing-off
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbidopaDrug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| Stalevo | Experimental | levodopa/carbidopa/entacapone Receives: Drug: Carbidopa |
| Placebo | Placebo comparator | Not described Receives: Drug: Carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of motor response by UPDRS III
Statistical method for the primary comparison will be analysis of variance (ANOVA) with the following grouping factors: treatment, sequence, subject, and period. Differences between Stalevo and treatment regimen A will be evaluated using orthogonal contrasts with 5% significance level.
Measured: 20 minute intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vilho Myllylä, Prof, Principal investigator, Oulu Deaconess Instutute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296464
- Sponsor's protocol ID
- 2939136
- Acronym
- PARTEST
- Status last verified
- Sep 2011
- First submitted
- 14 Feb 2011
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms
- ClinicalTrials.gov ID
- NCT01296464
- Acronym / sponsor ID
- PARTEST / 2939136
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Motor response, Wearing-off
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Feb 2011 (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 primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD.
Detailed description
This is a randomised, double-blind, 3-period crossover study comparing the effects of a single dose of two L/C/E treatment regimens (A and B) and standard L/C/E treatment regimen (Stalevo) on the duration of motor response in PD patients with wearing-off symptoms after the first morning dose of levodopa.
The study consists of a screening visit, 3 treatment visits and an end-of-study visit. Within 14 days of the screening visit, the patients will receive a single morning dose of study drug (either of the two L/C/E treatment regimens) or Stalevo. The order of the 3 treatment periods will be randomised according to a crossover design and the duration of each period is 2 days, followed by a wash-out period (1-9 days) during which the patients will be on their individual standard PD treatment.
Before each study day, patients will arrive at the study centre in the previous evening. The patients' own standard PD treatments will be discontinued at the latest by 22:00 to be continued after completion of the motor part (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III) next day. After completion of the UPDRS III, patients will return to their own standard PD treatments. Duration of the study will be 2 to 7 weeks per patient, depending on the length of the screening and wash-out periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stalevo | Experimental | Drug: Carbidopalevodopa/carbidopa/entacapone |
| Placebo | Placebo comparator | Drug: Carbidopa |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent (IC) obtained.
- Male or female patients with idiopathic PD according to the United Kingdom brain bank criteria with end-of-dose motor fluctuations
- Hoehn and Yahr stage 2-4 performed during the "ON" state.
- Duration of response between 1.5 and 4 hours (based on medical history) to the patient's first morning dose of levodopa/dopa decarboxylase inhibitor (DDCI) with or without entacapone.
- Treatment with 3-8 daily doses of levodopa/DDCI with or without entacapone with a total daily levodopa dose in the range of 300-1200 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed provided that it is included in the total of 3-8 daily doses of levodopa/DDCI mentioned above.
Key exclusion criteria (22 listed)
- Secondary or atypical parkinsonism.
- Use of tolcapone within 6 weeks prior to the first treatment period.
- Previous tolerability problems with entacapone or tolcapone.
- Concomitant treatment with apomorphine, MAO-A inhibitors or nonselective MAO inhibitors.
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception, an evening dose of an atypical antipsychotic is allowed.
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 |
|---|---|---|
| CarbidopaCapsules | Drug | Placebo, Stalevo |
Primary outcome
Duration of motor response by UPDRS III
Time frame: 20 minute intervals
Statistical method for the primary comparison will be analysis of variance (ANOVA) with the following grouping factors: treatment, sequence, subject, and period. Differences between Stalevo and treatment regimen A will be evaluated using orthogonal contrasts with 5% significance level.
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 12 Sep 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.
Vilho Myllylä, Prof principal investigator
Oulu Deaconess Instutute
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbidopa in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 5 sites in 2 countries.
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 7 inclusion and 22 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Duration of motor response by UPDRS III (time frame: 20 minute intervals). 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 12 Sep 2011.