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Restless Legs SyndromePhase 3NCT00355641

Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

A Phase 3 study testing Ropinirole Extended Release (XR) in people with Restless Legs Syndrome, run by GlaxoSmithKline at 65 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Restless Legs Syndrome
What is being tested?
Ropinirole Extended Release (XR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
65 sitesin 2 countries
Study dates
Oct 2005to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Subjects in North America ≥18 years of age who
  • Have successfully completed one of the following parent studies: 101468/205, ROX104805; OR
  • Have a diagnosis of primary RLS using the International RLS Study Group (IRSSG) Diagnostic Criteria (Appendix 10), experience RLS symptoms during both the evening (before 8 PM) and night-time, and have a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must be present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days).
  • Subjects must give written informed consent prior to any specific study procedures.

Who cannot join

  • Subjects who have any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis.
  • Subjects having clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
  • Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit.
  • Subjects with a history of augmentation and/or end-of-dose rebound symptoms.
  • Augmentation is defined as RLS symptoms that occurred while on treatment and occur ≥ 2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk.
  • End-of-dose rebound is defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication.
Show all 21Show fewer
  • Subjects who have exhibited intolerance to ropinirole.
  • For subjects entering Study 206, certain medications must be discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit:
  • ·dopamine agonists (including ropinirole immediate release formulation), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa The minimum discontinuation period is generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever is the longer period. If the subject will require longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must be consulted for further instructions.
  • Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and should be used with caution in patients taking ropinirole. For patients on stable doses, these agents may be permitted; however, it is recommended that the dose of the medication remain stable throughout the duration of the study.
  • Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
  • Women who have a positive pregnancy test.
  • Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant).
  • The following exclusion criteria must be assessed at Study 206 Screen/Baseline for subjects who are not rolling in following completion of Study 101468/205 or ROX104805:
  • Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
  • Subjects diagnosed with movement disorders (e.g., Parkinson's disease, dyskinesias, and dystonias).
  • Signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit)
  • Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
  • Subjects with a history of alcohol or substance abuse within the past year.
  • Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures
  • Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit

Trial locations and contacts

65 sites in 2 countries.

65 sites in 2 countries

United States59 sites

  • GSK Investigational Site

    Alabaster, Alabama, 35007

  • GSK Investigational Site

    Alexandria, Virginia, 22311

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70808

  • GSK Investigational Site

    Bingham Farms, Michigan, 48025

  • GSK Investigational Site

    Boca Raton, Florida, 33486

  • GSK Investigational Site

    Charlottesville, Virginia, 22911

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08003

  • GSK Investigational Site

    Cleveland, Ohio, 44130

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    Columbia, South Carolina, 29201

  • GSK Investigational Site

    Columbus, Ohio, 43232

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dawsonville, Georgia, 30534

  • GSK Investigational Site

    Denver, Colorado, 80212

  • GSK Investigational Site

    Endwell, New York, 13760

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Jackson, Tennessee, 38305

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Laguna Hills, California, 82653

  • GSK Investigational Site

    Largo, Florida, 33773

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Lenexa, Kansas, 66214

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Medford, Oregon, 97504-8456

  • GSK Investigational Site

    Mesa, Arizona, 85201

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    Northridge, California, 91325

  • GSK Investigational Site

    Oak Brook, Illinois, 60523

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Oxnard, California, 93030

  • GSK Investigational Site

    Pasadena, California, 91106

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Redondo Beach, California, 90277

  • GSK Investigational Site

    Reseda, California, 91355

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    Salt Lake City, Utah, 84121

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Schenectady, New York, 12308

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Massachusetts, 01104

  • GSK Investigational Site

    St. Petersburg, Florida, 33701

  • GSK Investigational Site

    Stuart, Florida, 34996

  • GSK Investigational Site

    Sun City, Arizona, 85351

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33609

  • GSK Investigational Site

    Toms River, New Jersey, 08755

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Walla Walla, Washington, 99362

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

Canada6 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Montreal, Quebec, H2T 2N6

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Official title: A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients With Restless Legs Syndrome (RLS)

The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.

Being tested
Ropinirole Extended Release (XR)
Keywords
Ropinirole, Restless Legs Syndrome, RLS
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropinirole Extended Release (XR)Drug

    Dose range of Ropinirole XR of 0.5mg to 6.0mg daily

Study groups in NCT00355641
Study groupRoleWhat they receive
Open LabelExperimentalAll subjects will receive ropinirole XR in this study. The total daily dose range of ropinirole XR will be 0.5mg to 6.0mg daily
Receives: Drug: Ropinirole Extended Release (XR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms).

    Measured: Up to 52 Weeks

Secondary outcomes (16)

  1. Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes.

    Measured: Up to 52 Weeks

  2. Incidence and severity of adverse events.

    Measured: Up to 52 Weeks

  3. Changes in vital signs (blood pressure and pulse) and weight.

    Measured: Up to 52 Weeks

  4. Changes in laboratory assessments (hematology and clinical chemistry).

    Measured: Up to 52 Weeks

  5. Changes in electrocardiogram (ECG) parameters.

    Measured: Up to 52 Weeks

  6. Assessment of augmentation.

    Measured: Up to 52 Weeks

  7. Assessment of rebound.

    Measured: Up to 52 Weeks

  8. Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward).

    Measured: Up to 52 Weeks

  9. Proportion of subjects with a score of much improved (2) or very much improved (1) on CGI-I at Week 52 LOCF.

    Measured: Up to 52 Weeks

  10. CGI Severity of Illness (CGI-S) at Week 52 LOCF.

    Measured: Up to 52 Weeks

  11. Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF.

    Measured: Up to 52 Weeks

  12. Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF.

    Measured: Up to 52 Weeks

  13. Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression (HADS) Scale at Week 52 LOCF.

    Measured: Up to 52 Weeks

  14. Change from baseline in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF.

    Measured: Up to 52 Weeks

  15. Change from baseline in the parameters for the work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF.

    Measured: Up to 52 Weeks

  16. Proportion of subjects satisfied with their treatment at Week 52 LOCF.

    Measured: Up to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355641
Sponsor's protocol ID
101468/206
Status last verified
Oct 2016
First submitted
20 Jul 2006
Last updated
28 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • C Hill-Zabala, R Bogan, D Lee, M Lomax. A 52-week open-label study to assess the long-term tolerability of Ropinirole CR Extended Release Tablets in subjects with Restless Legs Syndrome (RLS). 12th International Congress of Parkinson's Disease and Movement Disorders, Chicago, IL, June 22-26, 2008 (abstract 1112).

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropinirole Extended Release (XR) in people with Restless Legs Syndrome, run by GlaxoSmithKline at 65 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms). (time frame: Up to 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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