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

Seoul National University Hospital200 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Parkinson's Disease

Interventions

Mirapex ERDRUG

Change Requip or Mirapex to Mirapex ER

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Patient preference

Overall preference in QD versus BID

Time frame: 4 months

Secondary Outcomes

Motor complications

Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration

Time frame: 2 months at each arm

Sleep problems

Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)

Time frame: 2 months at each arm

Motor UPDRS and HY stage

Time frame: 2months at each arm

Side effects

Rating scale (0\~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others

Time frame: 2 months at each arm

Patient global impression for improvement

Time frame: 2 months at each arm

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

Time frame: 4 months

Patient choice

Patient choice in QD or BID Reason for the choice

Time frame: 4 months

Central Contacts

Beom S Jeon, MD, PhD

CONTACT

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

Ji Young Yun, MD

CONTACT

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

Data from ClinicalTrials.gov

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