Clinical trial NCT00256854: Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Official title: A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients With Restless Legs Syndrome (RLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Keywords: RLS
Ropinirole
Restless Legs Syndrome
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS
timeFrame: Up to 5 weeks
measure: Number of Participants With SAEs and Severity of AEs
timeFrame: Up to 5 weeks
measure: Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion
timeFrame: Up to 4 weeks
measure: Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion
timeFrame: Up to 5 weeks
measure: Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)
timeFrame: Up to 5 weeks
measure: Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion
timeFrame: Up to 5 weeks
measure: Change From Pre-conversion in Pulse Rate to One Week Post-conversion
timeFrame: Up to 5 weeks
measure: Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: GSK Investigational Site
state: California
city: Oxnard
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Reseda
country: United States
facility: GSK Investigational Site
state: California
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Springfield
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: GSK Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Plainview
country: United States
facility: GSK Investigational Site
state: New York
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Walla Walla
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: