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SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
This study is currently recruiting participants.
Verified by Medical College of Georgia, March 2008
First Received: June 23, 2006   Last Updated: October 13, 2009   History of Changes
Sponsor: Medical College of Georgia
Collaborator: GlaxoSmithKline
Information provided by: Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00344994
  Purpose

The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole for patients switched from pramipexole to ropinirole in patients with moderate to severe primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched from one dopamine agonist to an equipotent dose of another.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Mirapex(pramipexole) to Requip (Ropinirole)
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title: An Open-Label Prospective Study of Restless Legs Patients Switched to Ropinirole From Pramipexole to Help Determine the Equipotent Dose

Resource links provided by NLM:


Further study details as provided by Medical College of Georgia:

Primary Outcome Measures:
  • CGI-S/CGI-I: (Visits 1, 2, and 4)
  • IRLS: (Visits 1, 2, and 4)
  • Epworth Sleepiness Scale: (Visits 1, 2, and 4)
  • ECG: An "ECG" or "electrocardiogram" is a test that measures the electrical activity of the heart. (Visits 1, 2, and 4)

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: January 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent is obtained
  • Males and/or females; females of childbearing potential, who are not currently pregnant, must agree to use a medically accepted method of contraception throughout the study (i.e., oral contraception, intra- uterine device, or a long-acting injectable form of contraception). Barrier methods alone (i.e., condom) are not adequate.
  • Age > 18 years to ≤ 80 years
  • Patients with moderate to severe primary RLS
  • Stable dose of Pramipexole, between 0.25 mg and 0.75mg, for Restless Legs Syndrome for 4 weeks prior to enrollment
  • IRLS >15 (before pramipexole was initiated)

Exclusion Criteria:

Anyone who does not fit the criteria stated under "Inclusion Criteria" and anyone who is included in the following criteria:

  • Currently taking neuroleptic medications
  • Currently taking dopamine blocking anti-emetic medications.
  • Currently taking any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g., omeprazole) (Note: Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from (Visit 1) 14 days prior to Baseline to the end of the study.
  • Current hallucinations
  • History of disabling hallucinations or hallucinations in past requiring treatment
  • Mini-Mental status examination score < 25 on a scale of 30
  • Orthostatic hypotension >30 systolic drop and >20 diastolic drop
  • On cholinesterase inhibitors or memantine
  • Troublesome edema due to any reason
  • Epworth sleepiness scale >8
  • Another primary sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
  • Secondary causes of RLS (iron deficiency, renal failure)
  • Unstable medical conditions as determined by the investigator
  • Inadequately managed depression (patient on antidepressants must be on stable dose for 4 weeks prior to enrollment)
  • Other stable medical conditions which may interfere with patient evaluation
  • Female who is pregnant or lactating
  • Use of an investigational drug within the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344994

Contacts
Contact: Kapil D Sethi, MD 706-721-2798 ksethi@mcg.edu
Contact: John C Morgan, MD,PhD 706-721-2798 jmorgan@mcg.edu

Locations
United States, Georgia
Medical College of Georgia Recruiting
Augusta, Georgia, United States, 30912
Contact: Kapil D Sethi, MD     706-721-2798     ksethi@mcg.edu    
Contact: John C Morgan, MD, PhD     706-721-2798     jmorgan@mcg.edu    
Sponsors and Collaborators
Medical College of Georgia
GlaxoSmithKline
Investigators
Principal Investigator: Kapil D Sethi, MD Medical College of Georgia
  More Information

No publications provided

Study ID Numbers: gskswitch
Study First Received: June 23, 2006
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00344994     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Keywords provided by Medical College of Georgia:
Restless Legs Syndrome
Mirapex (pramipexole)
Requip(Ropinirole)
Dopamine Agonist

Additional relevant MeSH terms:
Neurotransmitter Agents
Ropinirole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Pramipexol
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Syndrome
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Protective Agents
Pharmacologic Actions
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009