Parkinson's DiseasePhase 2COMPOCNCT02764125
Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)
A Phase 2 study testing Stalevo and levodopa MR in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 4 sites in 4 countries.
Trial summary
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (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?
- Stalevo and levodopa MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 8 Apr 2016to 27 Mar 2018
- 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 UK brain bank criteria with end-of-dose wearing-off (motor fluctuations).
- Hoehn and Yahr stage 2-4 performed during the ON-state.
- At least 2 hours of OFF-time on each day (measured by the ON/OFF diary) on 3 consecutive days at the end of the screening period just before the baseline visit (visit 1).
- Treatment with 4-8 daily doses of levodopa/AADC inhibitor, either combined with entacapone (levodopa/AADC inhibitor combined with Comtess/Comtan or as Stalevo) or without entacapone, with a total daily levodopa dose from > 400 mg to ≤ 1200 mg with entacapone, or from > 400 mg to ≤ 1400 mg without entacapone. One evening dose of controlled release formulation, 1 morning dose of soluble levodopa/AADC inhibitor, or both, as needed are allowed.
- Unchanged levodopa/AADC inhibitor 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 before the screening visit.
- Age of 30 years or above.
Who cannot join
- Secondary or atypical Parkinsonism.
- Current use of tolcapone or opicapone (within 4 weeks before the screening visit).
- Previous tolerability problems with entacapone, tolcapone or opicapone.
- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors (within 4 weeks before the screening visit).
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception to prohibit use of antipsychotic drugs, 1 evening dose of an atypical antipsychotic is allowed.
- Use of concomitant medicine which is predominantly metabolised by CYP3A4 and which has a narrow therapeutic window such as ergot alkaloids, carbamazepine, cyclosporin, macrolides (sirolimus and tacrolimus), quinidine or fentanyl.
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- Current use of warfarin (within 4 weeks before the screening visit).
- Inability to refrain from use of any iron preparations during the study.
- Disabling dyskinesias.
- Problematic hallucinations within 3 months before the screening visit.
- Symptomatic orthostatic hypotension.
- Current dementia (Mini Mental State Examination [MMSE] score < 26).
- Problematic impulse control disorders (ICDs), such as pathological gambling, hypersexuality or compulsive shopping within 6 months before the screening visit.
- History of neuroleptic malignant syndrome (NMS), non-traumatic rhabdomyolysis, or both.
- Any neurosurgical intervention for the treatment of PD, including deep brain stimulation (DBS).
- Narrow-angle glaucoma or pheochromocytoma.
- Any active malignant cancer.
- Clinically significant cardiovascular (e.g. ischaemic heart disease, ventricular or supraventricular arrhythmias), pulmonary, GI (e.g. inflammatory bowel disease), 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 > 1.25 x upper limit of normal (ULN) at screening.
- Any other abnormal value of laboratory, vital signs or ECG (such as QTcF prolongation ≥ 450 ms) that may 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).
- Patients with pre-planned surgery requiring hospitalisation during the study.
- Known hypersensitivity to active substances or to any of the excipients of the study treatments.
- Blood donation or loss of significant amount of blood within 60 days before screening visit.
- Participation in a drug study within 60 days before the first treatment period.
- 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.
- Failure to demonstrate acceptable/appropriate use of the ON/OFF diary despite adequate training during the screening visit.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).
Read the detailed description
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in PD patients with end-of-dose wearing-off (motor fluctuations).
In a 2-period crossover design the subjects will receive ODM-104/levodopa/ carbidopa or Stalevo during the different study periods in a randomised order. There will be a screening period, 2 treatment periods and a post-treatment period, altogether 7 scheduled visits: a screening visit, a baseline visit, 4 visits during the treatment periods (i.e. 2 visits/each period), and an end-of-study visit. Unscheduled visits may be performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. The total study duration will be 10-15 weeks for each subject.
- Conditions
- Parkinson's Disease
- Being tested
- Stalevo, levodopa MR
- Keywords
- Parkinson's Disease, 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.
StalevoDrug
Also called levodopa/carbidopa/entacapone
levodopa/carbidopa/entacapone
levodopa MRDrug
Also called levodopa MR/carbidopa/ODM-104
levodopa MR/carbidopa/ODM-104
| Study group | Role | What they receive |
|---|---|---|
| Stalevo | Active comparator | levodopa/carbidopa/entacapone Receives: Drug: Stalevo |
| levodopa MR | Experimental | Levodopa MR/carbidopa/ODM-104 Receives: Drug: levodopa MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of daily OFF-time (measured by Hauser ON/OFF-diary)
OFF-time (time when the patient does not experience a positive response to medication between the study drug intake) measured from the Hauser ON/OFF-diary that patient has filled in (24 hour clock) for 3 days prior to baseline visit and at the end of both treatment periods.
Measured: 3 consecutive days in the end of both periods compared to 3 consecutive days prior the baseline visit.
Secondary outcomes (3)
Switching patients from their regular levodopa treatment to planned new treatment.
To explore how to switch patients on levodopa/aromatic amino acid decarboxylase (AADC) inhibitor or levodopa/AADC inhibitor + entacapone directly to ODM-104 in combination with MR levodopa and carbidopa by evaluating how much adjustments to levodopa strengths need to be done and if there is difference between the two treatment groups.
Measured: two 4 weeks study periods
Determination of sample size
To determine the effect size for phase III planning if the difference between the two study treatment groups with this amount of patients can be shown.
Measured: two 4 weeks study periods
To show adequate Parkinson's Disease symptom control with the new treatment
To study levodopa daily dose and dosing frequency of the combination to see if Parkinson's disease symptoms are adequately controlled with study treatment.
Measured: two 4 weeks study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start8 Apr 2016
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aila Holopainen, MSc, Study director, Orion Corporation, Orion Pharma, Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764125
- Sponsor's protocol ID
- 3112004
- Acronym
- COMPOC
- Status last verified
- Apr 2018
- First submitted
- 13 Jan 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off
- ClinicalTrials.gov ID
- NCT02764125
- Acronym / sponsor ID
- COMPOC / 3112004
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Wearing-off
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 6 May 2016 (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.
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).
Detailed description
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in PD patients with end-of-dose wearing-off (motor fluctuations).
In a 2-period crossover design the subjects will receive ODM-104/levodopa/ carbidopa or Stalevo during the different study periods in a randomised order. There will be a screening period, 2 treatment periods and a post-treatment period, altogether 7 scheduled visits: a screening visit, a baseline visit, 4 visits during the treatment periods (i.e. 2 visits/each period), and an end-of-study visit. Unscheduled visits may be performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. The total study duration will be 10-15 weeks for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stalevo | Active comparator | Drug: Stalevolevodopa/carbidopa/entacapone |
| levodopa MR | Experimental | Drug: levodopa MRLevodopa MR/carbidopa/ODM-104 |
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 UK brain bank criteria with end-of-dose wearing-off (motor fluctuations).
- Hoehn and Yahr stage 2-4 performed during the ON-state.
- At least 2 hours of OFF-time on each day (measured by the ON/OFF diary) on 3 consecutive days at the end of the screening period just before the baseline visit (visit 1).
- Treatment with 4-8 daily doses of levodopa/AADC inhibitor, either combined with entacapone (levodopa/AADC inhibitor combined with Comtess/Comtan or as Stalevo) or without entacapone, with a total daily levodopa dose from > 400 mg to ≤ 1200 mg with entacapone, or from > 400 mg to ≤ 1400 mg without entacapone. One evening dose of controlled release formulation, 1 morning dose of soluble levodopa/AADC inhibitor, or both, as needed are allowed.
Key exclusion criteria (27 listed)
- Secondary or atypical Parkinsonism.
- Current use of tolcapone or opicapone (within 4 weeks before the screening visit).
- Previous tolerability problems with entacapone, tolcapone or opicapone.
- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors (within 4 weeks before the screening visit).
- Concomitant treatment with drugs having antidopaminergic action including alpha-methyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics except domperidone). As an exception to prohibit 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 |
|---|---|---|
| StalevoAlso: levodopa/carbidopa/entacaponelevodopa/carbidopa/entacapone | Drug | Stalevo |
| levodopa MRAlso: levodopa MR/carbidopa/ODM-104levodopa MR/carbidopa/ODM-104 | Drug | levodopa MR |
Primary outcome
Duration of daily OFF-time (measured by Hauser ON/OFF-diary)
Time frame: 3 consecutive days in the end of both periods compared to 3 consecutive days prior the baseline visit.
OFF-time (time when the patient does not experience a positive response to medication between the study drug intake) measured from the Hauser ON/OFF-diary that patient has filled in (24 hour clock) for 3 days prior to baseline visit and at the end of both treatment periods.
3 secondary outcomes
Switching patients from their regular levodopa treatment to planned new treatment.
Time frame: two 4 weeks study periods
Determination of sample size
Time frame: two 4 weeks study periods
To show adequate Parkinson's Disease symptom control with the new treatment
Time frame: two 4 weeks study 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 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Aila Holopainen, MSc study director
Orion Corporation, Orion Pharma, Development
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stalevo and levodopa MR in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 4 sites in 4 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 27 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Germany, Hungary, Latvia. 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 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 daily OFF-time (measured by Hauser ON/OFF-diary) (time frame: 3 consecutive days in the end of both periods compared to 3 consecutive days prior the baseline visit.). 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 5 Apr 2018.