Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens (PARTEST)

September 9, 2011 updated by: Orion Corporation, Orion Pharma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Hämeenlinna, Finland, 13530
        • Kanta-Hämeen Keskussairaala
      • Oulu, Finland, 90100
        • ODL Terveys Oy (ODL)
      • Pori, Finland, 28100
        • Porin Lääkäritalo
  • Sweden
      • Jönköping, Sweden, SE-55185
        • Länssjukhuset Ryhov, Medicin/Neurologmottagningen
      • Stockholm, Sweden, SE-171 76
        • Karolinska Universitetssjukhuset Solna, Neurologkliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Carbidopa
Capsules
EXPERIMENTAL: Stalevo
levodopa/carbidopa/entacapone
Drug: Carbidopa
Capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
20 minute intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orion Corporation, Orion Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vilho Myllylä, Prof, Oulu Deaconess Instutute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2939136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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