Phase 3
N=135
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Restless Legs Syndrome · Restless Legs Syndrome (RLS)
Bottom Line
View on ClinicalTrials.gov: NCT00256854 ↗Enrolled (actual)
135
Serious AEs
0.7%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period — 9; 14; 10; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ropinirole IR 1 mg (Drug); Ropinirole IR 2 mg (Drug); Ropinirole IR 1 mg Placebo (Drug); Ropinirole IR 2 mg Placebo (Drug); Ropinirole CR 2 mg (Drug); Ropinirole CR 3 mg (Drug); Ropinirole CR 2 mg Placebo (Drug); Ropinirole CR 3 mg Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period |
9; 14; 10; 11; 7; 5 | — |
| SECONDARY Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With SAEs and Severity of AEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion |
14; 12; 10; 9; 6; 6 | — |
| SECONDARY Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion |
-5.1; -0.1; -1.5; -1.3; -5.8; 1.2 | — |
| SECONDARY Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) |
1; 1; 1; 1; 1; 2 | — |
| SECONDARY Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion |
-0.8; -3.9; 4.0; -7.7; -1.2; -5.3 | — |
| SECONDARY Change From Pre-conversion in Pulse Rate to One Week Post-conversion |
-0.1; -0.4; 1.0; -0.9; -1.5; 1.2 | — |
| SECONDARY Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure |
-20.0; -20.0; -6.0; -8.0; -6.4; -10.6 | — |
Summary
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
- Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
- Subjects with RLS symptoms during both the evening and night or night time only.
- Subjects who have given written informed consent to participate.
Exclusion Criteria
- Subjects who require treatment of daytime RLS symptoms.
- Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
- Movement Disorders, Clinically significant or unstable medical conditions.
- Abnormal labs, electrocardiogram (ECG) or physical findings.
- Receiving prohibited medications.
- Sleeping habits incompatible with study design.
- Intolerance to ropinirole or other dopamine agonist.
- Pregnant or lactating.
- Women of child-bearing potential who are not practicing an acceptable method of birth control.
Data sourced from ClinicalTrials.gov (NCT00256854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.