Trial Outcomes & Findings for Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS (NCT NCT01170091)

Results Overview

If there is a dose titration, another 4 weeks should be followed up

Recruitment status

COMPLETED

Target enrollment

651 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2014-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Mirapex Patients with RLS who had initiated with Mirapex
Overall Study STARTED	651
Overall Study COMPLETED	627
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirapex Patients with RLS who had initiated with Mirapex
Overall Study Missing efficacy evaluation	3
Overall Study Treatment duration is less than 4 weeks	21

Baseline Characteristics

Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Restless Legs Syndrome (RLS) n=651 Participants Patients with RLS who had initiated with Mirapex
Age, Continuous	60.9 Years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex/Gender, Customized Female	369 Participants n=5 Participants
Sex/Gender, Customized Male	276 Participants n=5 Participants
Sex/Gender, Customized Not reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set

If there is a dose titration, another 4 weeks should be followed up

Outcome measures

Outcome measures
Measure	Mirapex n=651 Participants Patients with RLS who had initiated with Mirapex
Number of Reported Adverse Events Gastrointestinal disorders	8 cases
Number of Reported Adverse Events Nervous system disorders	1 cases
Number of Reported Adverse Events General disorders and admin site conditions	2 cases
Number of Reported Adverse Events Psychiatric disorders	1 cases

SECONDARY outcome

Timeframe: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)

Population: Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)

a change in 10-item scale rated by the patient on 5 levels with a minimum ("none") sum score of 0 to maximum ("very severe") sum score of 40

Outcome measures

Outcome measures
Measure	Mirapex n=627 Participants Patients with RLS who had initiated with Mirapex
International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment	-14.7 Units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)

Population: Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)

PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."

Outcome measures

Outcome measures
Measure	Mirapex n=627 Participants Patients with RLS who had initiated with Mirapex
Patient-Global Impressions (PGI-I) Very much improved	177 patients
Patient-Global Impressions (PGI-I) Much improved	360 patients
Patient-Global Impressions (PGI-I) Minimally improved	45 patients
Patient-Global Impressions (PGI-I) No change	42 patients
Patient-Global Impressions (PGI-I) Minimally worse	2 patients
Patient-Global Impressions (PGI-I) Much worse	1 patients
Patient-Global Impressions (PGI-I) Very much worse	0 patients

SECONDARY outcome

Timeframe: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)

Population: Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)

CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."

Outcome measures

Outcome measures
Measure	Mirapex n=627 Participants Patients with RLS who had initiated with Mirapex
Clinical Global Impressions-Global Improvement (CGI-I) Very much improved	188 patients
Clinical Global Impressions-Global Improvement (CGI-I) Much improved	351 patients
Clinical Global Impressions-Global Improvement (CGI-I) Minimally improved	49 patients
Clinical Global Impressions-Global Improvement (CGI-I) No change	35 patients
Clinical Global Impressions-Global Improvement (CGI-I) Minimally worse	3 patients
Clinical Global Impressions-Global Improvement (CGI-I) Much worse	1 patients
Clinical Global Impressions-Global Improvement (CGI-I) Very much worse	0 patients

Adverse Events

Patients With Restless Legs Syndrome (RLS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER