Viewing Study NCT00344994



Ignite Creation Date: 2024-05-05 @ 4:54 PM
Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00344994
Status: COMPLETED
Last Update Posted: 2011-05-13
First Post: 2006-06-23

Brief Title: SWITCHRestless Legs Patients Switched to Ropinirole From Pramipexole
Sponsor: Augusta University
Organization: Augusta University

Study Overview

Official Title: An Open-Label Prospective Study of Restless Legs Patients Switched to Ropinirole From Pramipexole to Help Determine the Equipotent Dose
Status: COMPLETED
Status Verified Date: 2011-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: BACKGROUND Dopamine agonists such as ropinirole Requip and pramipexole Mirapex are effective treatments for Restless Legs Syndrome and Parkinson Disease However although the safety and efficacy may be established it is common for clinicians to switch between therapies in order to seek optimal symptomatic relief for their patients The best strategy for switching from other dopamine agonists to Requip is currently undetermined Currently ropinirole is the only medication indicated for the treatment of moderate to severe RLS

Every patient will have an individual response to each dopamine agonist Usually patients are switched from one dopamine agonist to another due to the following factors

Lack of response or loss of efficacy
Predictable and dose-related side effects
Ergot-associated adverse events pulmonary fibrosis cardiac valvulopathy etc
Sleep events sudden onset of sleep
Peripheral edema
Patient co-morbidities

The lack of clinical data makes it difficult to recommend switching guidelines that are suitable for all patients It is therefore recommended that the switching regimen be based on clinical judgment with individualization for each patient Switching from one dopamine agonist to another is dependent upon a number of factors including

1 The currently prescribed dopamine agonist
2 The dose of the current dopamine agonist
3 Whether dopamine agonist is being administered as monotherapy or as adjunct therapy to L-dopa
4 Individual patient response to both the current agonist and to the other dopamine agonist efficacy and tolerability
5 Stage of the disease

In placebo-controlled clinical trials for Requip a protocol for switching patients to Requip was not utilized Patients were generally required to discontinue previous dopamine agonist medications at least two weeks prior to baseline evaluation Patients already on dopamine agonists were discontinued according to the practices of the investigators

Methods of switching that have been studied previously include

1 Withdrawal of the current dopamine agonist according to the manufacturers recommendations followed by initiation of the other dopamine agonist based upon the manufacturers recommendations
2 An overnight switch with abrupt cessation of the current dopamine agonist followed by initiation of an estimated equivalent dose of the other dopamine agonist
3 Gradual withdrawal of the current dopamine agonist with simultaneous upward titration of the other dopamine agonist

STUDY DESIGN

SWITCH is a principal investigator-initiated open-label study that is being conducted at two sites to include the Medical College of Georgia and the VA Medical Center VAMC A total of 20 subjects will be enrolled at MCGVAMC Individuals who choose to participate will have approximately three to four study visits over a four week time period Patients with moderate to severe primary Restless Legs Syndrome will be included in the study All RLS medications will be at a stable dose for at least 4 weeks prior to enrollment Patients will be switched overnight at the Baseline Visit at a ratio of either 14 or 16 Mirapex pramipexole to Requip ropinirole per Conversion Table 1 below

Table 1 Conversion Table

Pramipexole Dose Requip Dose tablets

14 conversion

025mg------------------ 1mg 1X1mg

05mg ------------------ 2mg1X2mg

075mg-------------------3mg 1X 3mg

16 Conversion

025mg------------------15mg 3X05mg

05mg ------------------3mg 1X 3mg

075mg------------------4mg 1X4mg

At the baseline study visit a signed and dated consent will first be obtained from the subject In addition inclusionexclusion criteria will be reviewed before the start of any study procedures

During the course of the study some or all of the following procedures will be performed when patients come to the clinic for their study visit Table 2
Health and Medication Review Ask patients to answer questions about their health medical history and their medications All visits
Mini-Mental State Examination Patients will be asked a series of questions to determine their mental status Visit 1
CGI-SCGI-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
Blood Tests The study staff will draw about 3 tablespoons The study doctor will use this blood for Hematology and Chemistry panel laboratory tests Visit 1
Pregnancy Tests If the patient is female and can have children their blood about one extra tablespoon will be needed to perform this test will be tested to see if they are pregnant Patients will be told if the test results are positive The results of the test must be negative in order for the patient to be in the study Visit 1
Neurological and Physical Exam The study doctor will perform both a neurological and a physical exam Visit 1
Brief Physical Exam Visits 2 and 4
Concomitant Medication Review All visits
Blood Pressure Pulse Visits 1 2 and 4
Height Visit 1
Weight Visit 1
Study Drug Give patients a supply of study drug and tell them how to take it Patients will be asked to bring back all unused study drug to each visit Visits 1 2 and 4
Drug Compliance Visits 2 3 and 4
Adverse Event Review Visits 2 3 and 4
Telephone Contact The study doctor or study staff will call the patient to check on hisher health and see how heshe is handling the study drug If the study doctor decides that the patient is doing well on the medication Visit 3 could only consist of a telephone contact to include a review of concomitant medications adverse events and drug compliance If the patient is experiencing breakthrough symptoms a clinic visit will be required for Visit 3

All study visits will take approximately two 2 hours and the telephone contact should take no longer than thirty 30 minutes

Study Patients will see both the study coordinator and an investigator at every visit

At the end of study treatment subjects will be given treatment options subjects will have the option of continuing on ropinirole or returning to the use of pramipexole Subjects will then return to the care of their primary care physicianneurologist

USE OF HUMAN SUBJECTS andor HUMAN DERIVED MATERIALS

SUBJECT CHARACTERISTICS Patients with moderate to severe Restless Legs Syndrome that are currently taking a stable dose of Pramipexole will be approached during their visit to the MCG Movement Disorders Clinic and the VA Neurology Clinic and asked to participate in SWITCH If it becomes necessary to recruit from outside of MCGVAMC all advertisement materials will be submitted to the HAC for approval prior to use SWITCH is a double site study We plan to enroll a total of 25-30 individuals between the two sites Approximately 20 patients will be enrolled at MCGVAMC

MANAGING SIDE EFFECTS As with all drugs the possibility of unforeseeable risks and side effects exist The patients will be told of any important new information that might affect their decision to continue in the study in a timely manner Their Restless Legs Syndrome may not improve or may worsen despite participation In previous studies patients taking ropinirole reported the following side effects to include nausea headache dizziness drowsiness or sleepiness Individuals taking ropinirole may experience dizziness nausea sweaty or faintness when first standing up from lying down Hallucinations unreal visions sounds or sensations have also been reported in patients taking ropinirole especially in elderly patients patients taking ropinirole with L-dopa or patients taking higher amounts of ropinirole If a patient is taking L-dopa for Parkinsons disease ropinirole may worsen some of the side effects of L-dopa

Additionally ropinirole has been associated with sedating effects including somnolence and the possibility of falling asleep while engaged in activities of daily living including operation of a motor vehicle

Syncope or symptomatic hypertension may also occur particularly during initial treatment or dose titration Patients should be cautioned against rising rapidly after sitting or lying down Because of possible additive effects it is recommended that caution be exercised with patients who have sleep disorders or are taking sedating medications alcohol CNS depressants or medications that increase ropinirole plasma levels

Patients should get medical help and contact the study doctor or study staff if they have any of these or any other side effects during the study

If the study doctor considers that it is in the patients best interest to discontinue a current medication so that they can enter the study the patient may experience some withdrawal symptoms

The risks and discomforts of blood drawing from a vein include the possibility of pain or bruising at the site of the blood draw occasional feelings of lightheadedness and rarely infection at the site of the blood draw

Currently Ropinirole is an FDA approved drug for the treatment of RLS There are currently other medications used for the treatment of Restless Legs Syndrome such as Pramipexole gabapentin Sinemet clonazepam opiods pain medications benzodiazepines sleep medications anticonvulsants medications to prevent seizures and iron therapy The study doctor will discuss the benefits and risks associated with these alternatives with each patient

If a research related event arises the study team will manage the patients care In the event of an emergency the research team is available any time day or night via the MCG paging operator

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None