An open – label clinical trial to study pharmacokinetics (PK) of different levels (0.125 mg, 0,25 mg, 0.5 mg) of pramipexole taken once a day by month in children who can accepte stable pramipesole doses for the treatment of Restless Leg Syndrome (RLS) – A disorder which feel the urge to move the legs to reduce the unpleasant sensation

Registry ID

EUCTR2011-002774-23

Source registry

EUCTR

Phase

PHASE1

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc.

Last update

2026-08-16

Conditions

• Restless Legs Syndrome

Summary

The primary objective of the study was to assess the pharmacokinetics of PPX in pediatric RLS patients. The total and maximum exposure, absorption, distribution and elimination after multiple administration of low (0.125 to 0.5 mg) single daily doses of PPX for the treatment of RLS were estimated in the pediatric population.

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