SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00344994
First received: June 23, 2006
Last updated: May 12, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Georgia Regents University:

Primary Outcome Measures:
  • CGI-S/CGI-I: (Visits 1, 2, and 4) [ Time Frame: 5 min ] [ Designated as safety issue: No ]
  • IRLS: (Visits 1, 2, and 4) [ Time Frame: 5 min ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale: (Visits 1, 2, and 4) [ Time Frame: 5 min ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344994

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

No publications provided

Responsible Party: Dr. Kapil Sethi/ / PI, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT00344994     History of Changes
Other Study ID Numbers: gskswitch
Study First Received: June 23, 2006
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014