Clinical trial NCT01515774: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Pramipexole
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient preference
timeFrame: 4 months
Secondary outcomes:
measure: Motor complications
timeFrame: 2 months at each arm
measure: Sleep problems
timeFrame: 2 months at each arm
measure: Motor UPDRS and HY stage
timeFrame: 2months at each arm
measure: Side effects
timeFrame: 2 months at each arm
measure: Patient global impression for improvement
timeFrame: 2 months at each arm
measure: Preference in each factor
timeFrame: 4 months
measure: Patient choice
timeFrame: 4 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.