NCT01515774

Brief Summary

  1. 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. 2.In order to estimate the conversion rate of dopamine agonists into Mirapex ER

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 10, 2012

Last Update Submit

January 18, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasePramipexole

Outcome Measures

Primary Outcomes (1)

  • Patient preference

    Overall preference in QD versus BID

    4 months

Secondary Outcomes (7)

  • Motor complications

    2 months at each arm

  • Sleep problems

    2 months at each arm

  • Motor UPDRS and HY stage

    2months at each arm

  • Side effects

    2 months at each arm

  • Patient global impression for improvement

    2 months at each arm

  • +2 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Give QD dose first then BID dosing

Drug: Mirapex ER

Group 2

ACTIVE COMPARATOR

Give BID dosing and then QD dosing

Drug: Mirapex ER

Interventions

Mirapex ERDRUG

Change Requip or Mirapex to Mirapex ER

Group 1Group 2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20110012BACKGROUND

  • 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.

    PMID: 20669265BACKGROUND

  • 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.

    PMID: 28265478DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Beom S Jeon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beom S Jeon, MD, PhD

CONTACT

82-2-2072-2876brain@snu.ac.kr

Ji Young Yun, MD

CONTACT

82-2-2072-0359dream-yoon@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 24, 2012

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

KR(1)