search
Back to results

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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirapex ER
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Pramipexole

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Give QD dose first then BID dosing

Give BID dosing and then QD dosing

Outcomes

Primary Outcome Measures

Patient preference
Overall preference in QD versus BID

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2012
Last Updated
January 18, 2012
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01515774
Brief Title
Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 In order to estimate the conversion rate of dopamine agonists into Mirapex ER
Detailed Description
Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER 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 Dose adjustment may be done in the first 4 weeks. Compare the benefit, side effects, and patient preference between the QD vs BID dosing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Pramipexole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Give QD dose first then BID dosing
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Give BID dosing and then QD dosing
Intervention Type
Drug
Intervention Name(s)
Mirapex ER
Intervention Description
Change Requip or Mirapex to Mirapex ER
Primary Outcome Measure Information:
Title
Patient preference
Description
Overall preference in QD versus BID
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Motor complications
Description
Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration
Time Frame
2 months at each arm
Title
Sleep problems
Description
Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)
Time Frame
2 months at each arm
Title
Motor UPDRS and HY stage
Time Frame
2months at each arm
Title
Side effects
Description
Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others
Time Frame
2 months at each arm
Title
Patient global impression for improvement
Time Frame
2 months at each arm
Title
Preference in each factor
Description
Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience
Time Frame
4 months
Title
Patient choice
Description
Patient choice in QD or BID Reason for the choice
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 30-80 Parkinson disease On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER On stable antiparkinsonian medication for at least 4 weeks Who signed consent to the study Exclusion Criteria: Who are on less than 2 mg of Requip or 0.375 mg of Mirapex Who have dementia, psychosis, major depression and other serious neurological or medical problems Who are allergic to the similar medications Who has history of heavy metal poisoning Who were on othe clinical trials of other medications within the last 4 weeks Who are pregnant or lactating Who are considered not eligible by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beom S Jeon, MD, PhD
Phone
82-2-2072-2876
Email
brain@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Young Yun, MD
Phone
82-2-2072-0359
Email
dream-yoon@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beom S. Jeon, MD, PhD
Phone
82-2-2072-2876
Email
brain@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Y Yun, MD
Phone
82-2-2072-0359
Email
dream-yoon@hanmail.net
First Name & Middle Initial & Last Name & Degree
Beom S. Jeon, MD, PhD
First Name & Middle Initial & Last Name & Degree
Han-Joon Kim, MD
First Name & Middle Initial & Last Name & Degree
Ji Y Yun, MD
First Name & Middle Initial & Last Name & Degree
Young Eun Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20110012
Citation
Jenner P, Konen-Bergmann M, Schepers C, Haertter S. Pharmacokinetics of a once-daily extended-release formulation of pramipexole in healthy male volunteers: three studies. Clin Ther. 2009 Nov;31(11):2698-711. doi: 10.1016/j.clinthera.2009.10.018.
Results Reference
background
PubMed Identifier
20669265
Citation
Rascol O, Barone P, Hauser RA, Mizuno Y, Poewe W, Schapira AH, Salin L, Sohr M, Debieuvre C; Pramipexole Switch Study Group. Efficacy, safety, and tolerability of overnight switching from immediate- to once daily extended-release pramipexole in early Parkinson's disease. Mov Disord. 2010 Oct 30;25(14):2326-32. doi: 10.1002/mds.23262.
Results Reference
background
PubMed Identifier
28265478
Citation
Yun JY, Kim YE, Yang HJ, Kim HJ, Jeon B. Twice-Daily versus Once-Daily Pramipexole Extended Release Dosage Regimens in Parkinson's Disease. Parkinsons Dis. 2017;2017:8518929. doi: 10.1155/2017/8518929. Epub 2017 Feb 7.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs