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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

NCT01525641

Parkinson Disease

COMPLETED

A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease

NCT01485172

Parkinson Disease

COMPLETED PHASE4

Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily

NCT00986245

Parkinson Disease

COMPLETED PHASE4

Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD

NCT01807481

PD

UNKNOWN PHASE4

Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease

NCT03412513

Overactive Bladder Parkinson Disease

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Give QD dose first then BID dosing

Group Type ACTIVE_COMPARATOR

Mirapex ER

Intervention Type DRUG

Change Requip or Mirapex to Mirapex ER

Group 2

Give BID dosing and then QD dosing

Group Type ACTIVE_COMPARATOR

Mirapex ER

Intervention Type DRUG

Change Requip or Mirapex to Mirapex ER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirapex ER

Change Requip or Mirapex to Mirapex ER

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No