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SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344994
First Posted: June 27, 2006
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Augusta University
  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: pramipexole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Augusta University:

Primary Outcome Measures:
  • CGI-S/CGI-I: (Visits 1, 2, and 4) [ Time Frame: 5 min ]
  • IRLS: (Visits 1, 2, and 4) [ Time Frame: 5 min ]
  • Epworth Sleepiness Scale: (Visits 1, 2, and 4) [ Time Frame: 5 min ]
  • ECG: An "ECG" or "electrocardiogram" is a test that measures the electrical activity of the heart. (Visits 1, 2, and 4) [ Time Frame: 5 min ]

Estimated Enrollment: 20
Study Start Date: May 2006
Study Completion Date: April 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pramipexole
    PO, 0.25mg, 0.50mg, or 0.75mg QHS
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344994


Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
GlaxoSmithKline
Investigators
Principal Investigator: Kapil D Sethi, MD Augusta University
  More Information

Responsible Party: Dr. Kapil Sethi/ / PI, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT00344994     History of Changes
Other Study ID Numbers: gskswitch
First Submitted: June 23, 2006
First Posted: June 27, 2006
Last Update Posted: May 13, 2011
Last Verified: May 2011

Keywords provided by Augusta University:
Restless Legs Syndrome
Mirapex (pramipexole)
Requip(Ropinirole)
Dopamine Agonist

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