Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

NCT00530790 | Completed Phase 2 Results

• 1 other identifier: 107846
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 11

Brief Summary

This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (6)

• Drug Related Adverse Events-On-Therapy

  Weeks 1 - 12 Treatment Period

• Haematology Clinical Lab Values Change From Baseline

  Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.

  Baseline - Week 13 (Follow-up)

• Blood Chemistry Clinical Lab Values Change From Baseline

  Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L

  Baseline - Week 13 (Follow-up)

• Urinalysis Clinical Lab Values

  Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.

  Baseline - Week 13 (Follow-up)

• 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline

  Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.

  Baseline, Week 4, 8, 12, 13 (Follow-up)

• Vital Signs and Body Weight Change From Baseline

  Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.

  Baseline to Week 12/EW

Secondary Outcomes (11)

• Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score

  Baseline and after Week 12

• Clinical Global Impression Scale - Severity of Illness (CGI-S)

  Baseline - Final assessment point

• Clinical Global Impression Global Improvement (CGI-GI)

  Baseline - Final assessment point

• Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score

  Baseline - Week 12/EW

• Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains

  Baseline - Week 12/EW

Study Arms (1)

ropinirole CR-RLS

EXPERIMENTAL

Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day.

Drug: ropinirole controlled release (CR)-RLS

Interventions

ropinirole controlled release (CR)-RLS DRUG

White film-coated round-shaped tablet

Also known as: Ropinirole CR-RLS (SK&F101468)

ropinirole CR-RLS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At Week -1 (at the start of Screening period)
• Patients who are diagnosed with RLS according to the International RLS Study Group's (IRLSSG) Diagnostic Criteria.
• Age: Patients aged at least 18 years and under 80 years.
• Patients who have had RLS symptoms in the evening or nighttime (17:00 to 7:00 next day) for at least 20 days within one month before the start of the screening period. Patients treated for RLS before the start of the Screening period and who do not meet this criterion are considered eligible if the previous therapy can be discontinued from the Screening period.
• Patients who experience RLS symptoms requiring treatment after 17:00 but prior to bedtime.
• Abstinence
• Oral Contraceptive, either combined or progestogen alone
• Injectable progestogen
• Implants of levonorgestrel
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
• Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
• Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository
• Inpatient or outpatient status: Outpatient status

You may not qualify if:

• Patients requiring treatment for daytime RLS symptoms (7:00 to 17:00).
• Patients with signs of secondary RLS (e.g. chronic renal failure, iron-deficiency anemia, pregnancy, rheumatoid arthritis and Parkinson's disease).
• Patients whose serum ferritin level is \<10 μg/L (ng/mL) at the start of Screening period.
• Patients with following sleep disorder not associated with RLS e.g. narcolepsy, sleep terror disorder, sleep walking disorder, breathing related sleep disorder (Patients with obvious apnea in nighttime sleeping when they do not have alcohol drinking or over 15 times/hour is used to a target for apnea hypopnea index,in which case to implement polysomnography), etc.
• Patients with complication of movement disorder (e.g. Parkinson's disease, dyskinesia, dystonia, etc.).
• Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder.
• The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (Pharmaceutical affairs Bureau/Safety Division (PAB/SD) Notification No. 80, dated 29 June 1992).
• Patients with the medical history or complication of cancer or malignant tumour.
• Patients with the medical history or complication of substance abuse (e.g. alcohol or drug) or dependency of substance for the last one year
• Patients whose diastolic blood pressure (BP) is \>110 mmHg or \<50 mmHg or whose systolic BP is \>180 mmHg or \<90 mmHg at the start of Screening period and Week0.
• Patients intolerant for ropinirole hydrochloride (HCl) or other dopamine agonists.
• Patients with the medical history of allergy to ropinirole HCl in the past.
• Patients with the medical history of Augmentation to ropinirole HCl or other dopamine agonists in the past and those who have experienced early morning RLS symptoms.
• Augmentation is defined as below:
• RLS appear 2 hours earlier than the pre-treatment. Symptoms become severer than the pre-treatment. Symptoms which start after less time at rest than they did before treatment. The RLS extend to other sites (e.g. arm and trunk).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Fukuoka, 802-0084, Japan

Location

GSK Investigational Site

Fukuoka, 810-0044, Japan

Location

GSK Investigational Site

Fukuoka, 830-0011, Japan

Location

GSK Investigational Site

Hiroshima, 733-0031, Japan

Location

GSK Investigational Site

Kanagawa, 210-0024, Japan

Location

GSK Investigational Site

Osaka, 550-0004, Japan

Location

GSK Investigational Site

Osaka, 589-0022, Japan

Location

GSK Investigational Site

Osaka, 599-8263, Japan

Location

GSK Investigational Site

Tochigi, 321-0293, Japan

Location

GSK Investigational Site

Tokyo, 151-0053, Japan

Location

GSK Investigational Site

Tokyo, 187-0041, Japan

Location

Related Publications (1)

• GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 17, 2007
• Study Start: August 23, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 26, 2018
• Results First Posted: July 24, 2009

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (11)