Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Restless Legs Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256854
• Other study ID #: ROX104805
• Status: Completed
• Phase: Phase 3
• Start date: November 14, 2005
• Est. completion date: September 21, 2006

Study information

• Verified date: November 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 21, 2006
• Est. primary completion date: September 21, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

Drug:
• Ropinirole IR 1 mg
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.
• Ropinirole IR 2 mg
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.
• Ropinirole IR 1 mg Placebo
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.
• Ropinirole IR 2 mg Placebo
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
• Ropinirole CR 2 mg
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.
• Ropinirole CR 3 mg
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.
• Ropinirole CR 2 mg Placebo
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
• Ropinirole CR 3 mg Placebo
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Laguna Hills	California
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oxnard	California
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Plainview	New York
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Reseda	California
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toms River	New Jersey
United States	GSK Investigational Site	Walla Walla	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period	AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.	Up to 5 weeks
Secondary	Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS	AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.	Up to 5 weeks
Secondary	Number of Participants With SAEs and Severity of AEs	SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.	Up to 5 weeks
Secondary	Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion	Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1="Very much improved" to 7="Very much worse"). Typically, a participant with a score of 1 were considered as "Very much improved" and 2 as "Much improved" responder. Positive response was given in terms of worsen to stable or stable to improved.	Up to 4 weeks
Secondary	Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion	The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the "Week 1" total score from the "Week 2" total score for the first conversion and the "Week 3" total score from the "Week 4" total score for the second conversion.	Up to 5 weeks
Secondary	Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)	The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.	Up to 5 weeks
Secondary	Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion	Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the Week 3" values.	Up to 5 weeks
Secondary	Change From Pre-conversion in Pulse Rate to One Week Post-conversion	Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the "Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the "Week 3" values.	Up to 5 weeks
Secondary	Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure	Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the "post evening dose" values minus the "pre evening dose" values at the Week 1 visit and the changes for the second conversion were the "post evening dose" values minus the "pre evening dose" values at the Week 3 visit.	Up to 5 weeks

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