Parkinson's DiseasePhase 2PARPOCNCT01766258
Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations
A Phase 2 study testing ODM-101 65mg Carbidopa, ODM-101 105mg Carbidopa and Stalevo in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma.
Trial summary
The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations. 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?
- ODM-101 65mg Carbidopa, ODM-101 105mg Carbidopa and Stalevo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Sep 2012
- 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.
- An average of 3.0 hours of off time, with a minimum of 0.5 hours of off time on each day (using PD home diary [hereafter diary]) on 3 consecutive days before the decision of entry.
- Treatment with 3-8 daily doses of levodopa/dopa decarboxylase inhibitor (DDCI) with entacapone (either levodopa/DDCI combined with Comtess®/Comtan® or as Stalevo®) or without entacapone, including daily use of soluble levodopa formulation, with a total daily levodopa dose in the range of 400-1400 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed providing that it is included in the total daily levodopa dose in the range of 400-1400 mg mentioned above. Use of additional soluble levodopa formulations as rescue treatment, such as Madopar LT or Quick, up to a maximum of 4 doses per week is allowed; however, its use should be avoided on days during which PD status (diary) is recorded. The levodopa dose from these rescue soluble levodopa formulations is not included in the range of total daily dose of levodopa indicated above.
- Unchanged levodopa/DDCI with or without entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase [MAO] B inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 4 weeks prior to the screening visit.
- Age of 30 years or above.
Who cannot join
- Secondary or atypical parkinsonism.
- Current 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 non-selective MAO inhibitors.
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also dopamine D2 receptor blocking antiemetics except domperidone). As an exception to the prohibition of use of antipsychotic drugs, 1 evening dose of an atypical antipsychotic is allowed.
- Severe dyskinesias as judged by the investigator; however, mild to moderate dyskinesia not significantly affecting patient's activities of daily living is allowed.
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- Currently active hallucinations.
- Severe orthostatic hypotension as judged by the investigator.
- Current dementia (Mini-Mental State Examination [MMSE] score < 24).
- Problematic impulse control disorders (ICD) such as pathological gambling, hypersexuality or compulsive shopping within 6 months prior to the screening visit.
- History of neuroleptic malignant syndrome (NMS) and/or non-traumatic (drug-induced) rhabdomyolysis.
- Past or current treatment with deep brain stimulation (DBS) or other surgical treatment for PD.
- Narrow-angle glaucoma or pheochromocytoma.
- Any active malignant cancer.
- Patients with pre-planned elective surgery that is likely to change or impact on the control of PD symptoms, or involve hospitalisation.
- Failure to demonstrate acceptable/appropriate use of the diary, despite adequate training, during the screening visit or other separate training sessions during the screening period.
About this study
Official title: Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations
The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.
Read the detailed description
This is a randomised, double-blind, double-dummy, active-controlled, crossover, multicentre, phase II proof of concept study in patients with PD and end-of-dose motor fluctuations. The patient's individually optimised daily levodopa regimen must be kept stable for at least 2 weeks before randomisation. The patients will be randomised to receive ODM-101 with 65 mg of carbidopa, ODM-101 with 105 mg of carbidopa and Stalevo® according to a 3-period crossover design.
The study consists of a screening period, 3 treatment periods and a post-treatment period. For each patient,there will be 9 visits: a screening visit performed 7-28 days before randomisation, a randomisation visit (visit 1), 6 visits during the 3 treatment periods (i.e. 2, 4, 6, 8, 10 and 12 weeks after randomisation and the start of the study treatment; visits 2-7), and an end-of-study visit 7-21 days after the last visit of the last treatment period. The duration of study will be 14-23 weeks for each patient.
The patients switch to study drugs after all assessments have been done at visit 1. The strength of the levodopa in the study drug is determined by the patient's individually optimised levodopa regimen before randomisation. During the first 2 weeks of each treatment period, the patient's levodopa strength (but not frequency) in the study drug will be adjusted as necessary by the investigator. For the remaining 2 weeks of each treatment period, the levodopa strengths should be kept stable.
Unscheduled visits maybe performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. In case the patient has not contacted the study centre within a week after the start of the treatment period, the study personnel will phone the patient to ensure that the symptoms and possible adverse events (AEs) are sufficiently controlled and captured, and to assess the need to adjust the levodopa treatment.
- Conditions
- Parkinson's Disease
- Being tested
- ODM-101 65mg Carbidopa, ODM-101 105mg Carbidopa, Stalevo
- Keywords
- Parkinson's Disease, Motor-fluctuation, 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.
ODM-101 65mg CarbidopaDrug
ODM-101 105mg CarbidopaDrug
StalevoDrug
| Study group | Role | What they receive |
|---|---|---|
| Stalevo | Active comparator | levodopa/carbidopa/entacapone Receives: Drug: Stalevo |
| ODM-101 65mg Carbidopa | Experimental | levodopa/carbidopa/entacapone Receives: Drug: ODM-101 65mg Carbidopa |
| ODM-101 105mg Carbidopa | Experimental | levodopa/carbidopa/entacapone Receives: Drug: ODM-101 105mg Carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of off time
Duration of off time measured by the diary will be analysed using analysis of variance (ANOVA) model for cross-over design.
Measured: Average per day (over 3 consecutive days during the last 2 weeks of each treatment period).
Secondary outcomes (1)
Unified Parkinson's disease rating Scale (UPDRS) I-IV and the sum of UPDRS II and III ('total score')
UPDRS I-IV and the sum of UPDRS II and III ('total score') asses by the investigator analysed using ANOVA model for crossover design.
Measured: Weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionSep 2012
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'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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Trenkwalder, MD, Principal investigator, Paracelsus-Elena-Klinik, Klinikstr. 16, 34128 Kassel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766258
- Sponsor's protocol ID
- 2939135
- Acronym
- PARPOC
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2012
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Trenkwalder C, Kuoppamaki M, Vahteristo M, Muller T, Ellmen J. Increased dose of carbidopa with levodopa and entacapone improves "off" time in a randomized trial. Neurology. 2019 Mar 26;92(13):e1487-e1496. doi: 10.1212/WNL.0000000000007173. Epub 2019 Mar 1.
PubMed 30824559
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations
- ClinicalTrials.gov ID
- NCT01766258
- Acronym / sponsor ID
- PARPOC / 2939135
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Motor-fluctuation, Wearing-off
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jan 2013 (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 of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.
Detailed description
This is a randomised, double-blind, double-dummy, active-controlled, crossover, multicentre, phase II proof of concept study in patients with PD and end-of-dose motor fluctuations. The patient's individually optimised daily levodopa regimen must be kept stable for at least 2 weeks before randomisation. The patients will be randomised to receive ODM-101 with 65 mg of carbidopa, ODM-101 with 105 mg of carbidopa and Stalevo® according to a 3-period crossover design.
The study consists of a screening period, 3 treatment periods and a post-treatment period. For each patient,there will be 9 visits: a screening visit performed 7-28 days before randomisation, a randomisation visit (visit 1), 6 visits during the 3 treatment periods (i.e. 2, 4, 6, 8, 10 and 12 weeks after randomisation and the start of the study treatment; visits 2-7), and an end-of-study visit 7-21 days after the last visit of the last treatment period. The duration of study will be 14-23 weeks for each patient.
The patients switch to study drugs after all assessments have been done at visit 1. The strength of the levodopa in the study drug is determined by the patient's individually optimised levodopa regimen before randomisation. During the first 2 weeks of each treatment period, the patient's levodopa strength (but not frequency) in the study drug will be adjusted as necessary by the investigator. For the remaining 2 weeks of each treatment period, the levodopa strengths should be kept stable.
Unscheduled visits maybe performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. In case the patient has not contacted the study centre within a week after the start of the treatment period, the study personnel will phone the patient to ensure that the symptoms and possible adverse events (AEs) are sufficiently controlled and captured, and to assess the need to adjust the levodopa treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stalevo | Active comparator | Drug: Stalevolevodopa/carbidopa/entacapone |
| ODM-101 65mg Carbidopa | Experimental | Drug: ODM-101 65mg Carbidopalevodopa/carbidopa/entacapone |
| ODM-101 105mg Carbidopa | Experimental | Drug: ODM-101 105mg Carbidopalevodopa/carbidopa/entacapone |
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.
- An average of 3.0 hours of off time, with a minimum of 0.5 hours of off time on each day (using PD home diary [hereafter diary]) on 3 consecutive days before the decision of entry.
- Treatment with 3-8 daily doses of levodopa/dopa decarboxylase inhibitor (DDCI) with entacapone (either levodopa/DDCI combined with Comtess®/Comtan® or as Stalevo®) or without entacapone, including daily use of soluble levodopa formulation, with a total daily levodopa dose in the range of 400-1400 mg. One evening dose of controlled-release formulation of levodopa/DDCI is allowed providing that it is included in the total daily levodopa dose in the range of 400-1400 mg mentioned above. Use of additional soluble levodopa formulations as rescue treatment, such as Madopar LT or Quick, up to a maximum of 4 doses per week is allowed; however, its use should be avoided on days during which PD status (diary) is recorded. The levodopa dose from these rescue soluble levodopa formulations is not included in the range of total daily dose of levodopa indicated above.
Key exclusion criteria (16 listed)
- Secondary or atypical parkinsonism.
- Current 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 non-selective MAO inhibitors.
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also dopamine D2 receptor blocking antiemetics except domperidone). As an exception to the prohibition of use of antipsychotic drugs, 1 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 |
|---|---|---|
| ODM-101 65mg Carbidopa | Drug | ODM-101 65mg Carbidopa |
| ODM-101 105mg Carbidopa | Drug | ODM-101 105mg Carbidopa |
| Stalevo | Drug | Stalevo |
Primary outcome
Duration of off time
Time frame: Average per day (over 3 consecutive days during the last 2 weeks of each treatment period).
Duration of off time measured by the diary will be analysed using analysis of variance (ANOVA) model for cross-over design.
1 secondary outcome
Unified Parkinson's disease rating Scale (UPDRS) I-IV and the sum of UPDRS II and III ('total score')
Time frame: Weeks 4, 8 and 12
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 21 Nov 2013.
- Derived from this study: PubMed 30824559Trenkwalder C, Kuoppamaki M, Vahteristo M, Muller T, Ellmen J. Increased dose of carbidopa with levodopa and entacapone improves "off" time in a randomized trial. Neurology. 2019 Mar 26;92(13):e1487-e1496. doi: 10.1212/WNL.0000000000007173. Epub 2019 Mar 1.
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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.
Claudia Trenkwalder, MD principal investigator
Paracelsus-Elena-Klinik, Klinikstr. 16, 34128 Kassel, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ODM-101 65mg Carbidopa, ODM-101 105mg Carbidopa and Stalevo in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma.
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 16 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 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 off time (time frame: Average per day (over 3 consecutive days during the last 2 weeks of each treatment period).). 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 NCT01766258, 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 21 Nov 2013.