Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

January 18, 2012 updated by: BS Jeon, Seoul National University Hospital

An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease

  1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing
  2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER

  2. Cross over study design:

    • Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months
    • Group 2: BID in divided dose for 2 months then into QD dose for 2 months
  3. Dose adjustment may be done in the first 4 weeks.
  4. Compare the benefit, side effects, and patient preference between the QD vs BID dosing

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Beom S. Jeon, MD, PhD
          • Phone Number: 82-2-2072-2876
          • Email: brain@snu.ac.kr
        • Contact:
        • Principal Investigator:
          • Beom S. Jeon, MD, PhD
        • Sub-Investigator:
          • Han-Joon Kim, MD
        • Sub-Investigator:
          • Ji Y Yun, MD

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

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 30-80
  2. Parkinson disease
  3. On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
  4. On stable antiparkinsonian medication for at least 4 weeks
  5. Who signed consent to the study

Exclusion Criteria:

  1. Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
  2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
  3. Who are allergic to the similar medications
  4. Who has history of heavy metal poisoning
  5. Who were on othe clinical trials of other medications within the last 4 weeks
  6. Who are pregnant or lactating
  7. Who are considered not eligible by the investigator

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Give QD dose first then BID dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER
ACTIVE_COMPARATOR: Group 2
Give BID dosing and then QD dosing
Drug: Mirapex ER
Change Requip or Mirapex to Mirapex ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preference
Time Frame: 4 months
Overall preference in QD versus BID
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor complications
Time Frame: 2 months at each arm
Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration
2 months at each arm
Sleep problems
Time Frame: 2 months at each arm
Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)
2 months at each arm
Motor UPDRS and HY stage
Time Frame: 2months at each arm
2months at each arm
Side effects
Time Frame: 2 months at each arm
Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others
2 months at each arm
Patient global impression for improvement
Time Frame: 2 months at each arm
2 months at each arm
Preference in each factor
Time Frame: 4 months
Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience
4 months
Patient choice
Time Frame: 4 months
Patient choice in QD or BID Reason for the choice
4 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

October 1, 2012

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (ESTIMATE)

January 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1104-062-358

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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