NCT00344994

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

June 23, 2006

Last Update Submit

May 12, 2011

Conditions

Restless Legs Syndrome

Keywords

Restless Legs SyndromeMirapex (pramipexole)Requip(Ropinirole)Dopamine Agonist

Outcome Measures

Primary Outcomes (4)

  • CGI-S/CGI-I: (Visits 1, 2, and 4)

    5 min

  • IRLS: (Visits 1, 2, and 4)

    5 min

  • Epworth Sleepiness Scale: (Visits 1, 2, and 4)

    5 min

  • ECG: An "ECG" or "electrocardiogram" is a test that measures the electrical activity of the heart. (Visits 1, 2, and 4)

    5 min

Interventions

pramipexoleDRUG

PO, 0.25mg, 0.50mg, or 0.75mg QHS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kapil D Sethi, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2007

Study Completion

April 1, 2010

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

US(1)