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

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

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Busan, South Korea

About this study

Study Design:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Number of Reported Adverse Events

Time frame: Up to 4 weeks

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

Secondary outcomes

International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment

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

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
Patient-Global Impressions (PGI-I)

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

PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."
Clinical Global Impressions-Global Improvement (CGI-I)

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

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2011
First posted: Jul 27, 2010
Registry last updated: Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed