Ropinirole Tablets In Young Patients With Restless Legs Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Restless Leg Syndrome, Neurology |
| Therapuetic Areas: | Neurology, Rheumatology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | June 2005 |
| End Date: | December 2007 |
An Open Label, Single Dose, Dose Rising, Multi-centre Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescent Patients With RLS.
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent
patients with restless legs syndrome (RLS) in order to determine the starting dose for the
ropinirole titration regimen for this age group. Patients will receive two single doses
unless poor tolerability is observed following the first dose.
patients with restless legs syndrome (RLS) in order to determine the starting dose for the
ropinirole titration regimen for this age group. Patients will receive two single doses
unless poor tolerability is observed following the first dose.
Inclusion Criteria:
- Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
Exclusion Criteria:
- Subjects who require RLS treatment during the daytime, suffer from other primary
sleep disorders or are taking medication known to induce drowsiness, affect RLS or
sleep, or to induce or treat alertness, including methylphenidate.
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