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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01515774
• Other study ID #: H-1104-062-358
• Status: Unknown status
• Phase: Phase 4
• First received: January 10, 2012
• Last updated: January 18, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2012
• Source: Seoul National University Hospital
• Contact: Beom S Jeon, MD, PhD
• Phone: 82-2-2072-2876
• Email: brain[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Mirapex ER
Change Requip or Mirapex to Mirapex ER

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Jenner P, Könen-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient preference	Overall preference in QD versus BID	4 months
Secondary	Motor complications	Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration	2 months at each arm
Secondary	Sleep problems	Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS)	2 months at each arm
Secondary	Motor UPDRS and HY stage		2months at each arm
Secondary	Side effects	Rating scale (0~10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others	2 months at each arm
Secondary	Patient global impression for improvement		2 months at each arm
Secondary	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	4 months
Secondary	Patient choice	Patient choice in QD or BID Reason for the choice	4 months