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Parkinson´s DiseasePhase 2NCT00562198

PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding

A Phase 2 study testing entacapone and carbidopa and Sinemet 200mg/50mg in people with Parkinson´s Disease, run by Orion Corporation, Orion Pharma at 5 sites in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson´s Disease
What is being tested?
entacapone and carbidopa and Sinemet 200mg/50mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
5 sitesFinland
Study dates
Jan 2008to May 2008
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients with idiopathic Parkinson's disease according to the UK Brain Bank criteria.
  • Predictable wearing-off symptoms with a response to standard release levodopa/carbidopa (200/50 mg)during the levodopa challenge test lasting for a minimum of 1.5 h and a maximum of 4 h.
  • The magnitude of response (peak effect) in the levodopa challenge test is at least 30%. The magnitude of response is defined to be the difference between the baseline score and the lowest UPDRS III score during the levodopa challenge test.
  • Hoehn and Yahr stage of at least 2.0 performed during the "ON" state.
  • Treatment with at least 4 daily doses of levodopa/dopa decarboxylase inhibitor (DDCI) (± entacapone(Comtess® or Stalevo) with total daily levodopa dose in the range of 400-1200mg.
  • Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication [dopamine agonists,monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with an approved dose], if any, for at least 2 weeks prior to period I.
  • Written informed consent obtained.
  • Age of 45-80 years, inclusive.

Who cannot join

  • Secondary or atypical parkinsonism.
  • Patients with any unpredictable "OFF"-periods.
  • Patients with moderate to severe treatment-related peak-dose dyskinesia likely to affect the quality of brain magnetic resonance image (MRI) or positron emission tomography (PET) imaging.
  • Failure to adequately respond to the levodopa (levodopa/carbidopa 200/50 mg) challenge test with the duration of response lasting less than 1.5 h or more than 4 h.
  • Presence of a basal ganglia lesion in the MRI image or any other factor(s) that would make MRI or PET imaging likely to be unsatisfactory.
  • Presence of any ferromagnetic objects that would make brain MRI imaging contraindicated.
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  • Patients with a history of 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 including the interpretation and usage of MRI and PET images for the study purposes.
  • History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
  • Severe hepatic impairment.
  • Any abnormal electrocardiogram (ECG) finding with clinical relevance.
  • Female patients of childbearing potential (menstruating or less than 2 years post-menopausal) if they are not using adequate contraception during the study (defined as hormonal contraception, intrauterine device or surgical sterilization) or female patients who are pregnant or lactating.
  • Treatment with cabergoline.
  • Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
  • Concomitant treatment with any drugs with antidopaminergic action (e.g. with D2 receptor blocking properties) less than two weeks or within five times the elimination half-life of a given drug prior to the first study drug administration. As an exception, the use of domperidone is allowed.
  • Current, regular use of any iron preparation that cannot be interrupted for the duration of the study
  • Patients who are likely to need a rescue dose of levodopa after the withdrawal from their own levodopa/DDCI ± entacapone medication prior to PET imaging.
  • Known hypersensitivity to active study drug substances or to any of the excipients.
  • Participation in other drug studies within 30 days prior to study entry.
  • Blood donation or loss of significant amount of blood within 60 days prior to the screening.
  • Any other condition that in the opinion of the investigator could create a hazard to the subject safety,endanger the study procedures or interfere with the interpretation of study results.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Finland5 sites

  • Helsinki University Hospital, Department of Neurology

    Helsinki, 00029

  • Oulu University Hospital, Department of Neurology

    Oulu, 90220

  • Porin Lääkäritalo

    Pori, 28100

  • FinnMedi Tutkimus Oy

    Tampere, 33520

  • CRST

    Turku, 20520

Other trials in Finland

About this study

Official title: Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study.

This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet. After the wash-out the study drug on period 2 will be administered according to a crossover design.

Being tested
entacapone and carbidopa, Sinemet 200mg/50mg
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • entacapone and carbidopaDrug

    Entacapone 200mg carbidopa 50mg

  • Sinemet 200mg/50mgDrug

    Sinemet 200mg/50mg once

Study groups in NCT00562198
Study groupRoleWhat they receive
1ExperimentalInvestigational drug Stalevo 200
Receives: Drug: entacapone and carbidopa; Drug: Sinemet 200mg/50mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference between the study drugs in change in striatal 11C-raclopride BP.Striatal 11C-raclopride BP will be determined with PET scans performed at baseline and from 2.5 to 3.5 h after the study drug administration.

    Measured: Post-dosing PET scan

Secondary outcomes (1)

  1. The difference between the study drugs in levodopa mean C2.5- 3.5h.

    Measured: C 2.5-3.5h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionFeb 2008
  4. Study completionMay 2008

Why it stopped: Illogistical results found in interim evaluation.

Resources

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
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00562198
Sponsor's protocol ID
2939121
Status last verified
Jun 2008
First submitted
19 Nov 2007
Last updated
16 Jun 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing entacapone and carbidopa and Sinemet 200mg/50mg in people with Parkinson´s Disease, run by Orion Corporation, Orion Pharma at 5 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 8 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: stopped early, as of the sponsor's last update on 16 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 5 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 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 was stopped early (reason given: Illogistical results found in interim evaluation.). Results are not available in the source record.

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?

The difference between the study drugs in change in striatal 11C-raclopride BP.Striatal 11C-raclopride BP will be determined with PET scans performed at baseline and from 2.5 to 3.5 h after the study drug administration. (time frame: Post-dosing PET scan). 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 NCT00562198.

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 16 Jun 2008.

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