Clinical trial NCT01170091: Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Official title: Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General hospitals, primary care clinics

Brief summary: Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Detailed description: Study Design:

Eligibility criteria: Inclusion criteria:

1. Moderate to severe Primary Restless Legs Syndrome
2. Male or female patients aged at least 18 years

Exclusion criteria:

1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Mirapex
3. Pregnant and breastfeeding women
4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
5. Secondary RLS

Primary outcomes:
measure: Number of Reported Adverse Events
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment
timeFrame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
measure: Patient-Global Impressions (PGI-I)
timeFrame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
measure: Clinical Global Impressions-Global Improvement (CGI-I)
timeFrame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 1
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 2
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 3
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 32
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 33
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 34
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 35
city: Deajeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 36
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 25
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 26
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 27
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 28
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 29
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 30
city: Gwangju
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 31
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 10
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 11
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 12
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 13
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 14
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 15
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 16
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 17
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 18
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 19
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 20
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 21
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 22
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 23
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 24
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 4
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 5
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 6
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 7
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 8
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 9
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: