Switching From Oral Dopamine Agonists to Rotigotine

NCT01976871 | Completed Phase 4 Results

• 1 other identifier: MGH - 2013P000968
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate safety and tolerability of switching patients with Restless Legs Syndrome (RLS) from an oral dopamine agonist to rotigotine. As a secondary objective, the investigators will evaluate control of RLS symptoms on rotigotine compared to the prior oral regimen.

Conditions

Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease

Keywords

Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease; Rotigotine; Neupro; Dopamine Agonist

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Completing the Switch and Their Adverse Events

  The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine. The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment. Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved. Adverse Events are reported in the Adverse Events module.

  Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits

Secondary Outcomes (5)

• International Restless Legs Scale (IRLS)

  Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)

• RLS-6 Scale

  Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)

• Preference of Medication Scale (POM)

  Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)

• The Patient Global Impression of Change Scale

  Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)

• The Clinician Global Impression of Change Scale

  Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)

Study Arms (1)

Oral Dopamine Agonist to Rotigotine

EXPERIMENTAL

During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.

Drug: Rotigotine

Interventions

Rotigotine DRUG

Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator.

Also known as: Neupro

Oral Dopamine Agonist to Rotigotine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of RLS, defined by International Restless Legs Study Group (IRLS) essential criteria:
• An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
• The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting.
• The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
• The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
• (Although some subjects may not meet these criteria on their current oral regimen, these symptoms must have been present prior to treatment.)
• Current treatment with either pramipexole (≤1 mg total daily dose) or ropinirole (≤4 mg total daily dose) with unchanged dose for the past 30 days. Patients also on other RLS medications will be allowed to participate if the dosing has been stable for the past 30 days and the subject agrees to maintain a stable dose for the duration of the trial.
• Inadequate symptom control or patient dissatisfaction with current oral regimen.
• Able to speak and read English.
• Able to provide informed consent.
• Able to learn and demonstrate appropriate patch application.
• Returns appropriately completed RLS symptom log at Visit 2.
• Confirms understanding of cross-titration schedule and is able to restate or summarize these instructions at Visit 2.
• Age ≥18 and ≤75.
• BMI ≥18 and ≤35

You may not qualify if:

• Known secondary cause of RLS, including end-stage renal disease, severe iron deficiency (ferritin \<18), pregnancy.
• History of frequent symptomatic orthostatic hypotension.
• Current treatment with a dopamine antagonist medication.
• Another chronic pain syndrome that would, in the opinion of the investigator, interfere with evaluation of RLS symptoms or the response to the study medication.
• Plan to undergo a procedure that may require short or long-term opiates for pain control during the course of the trial.
• Women who are pregnant, lactating, or planning to become pregnant.
• Shift work or other commitments that do not allow for regular sleep at night.
• Known hypersensitivity or intolerance to rotigotine.
• Known allergy to sulfite-containing drugs.
• History of problematic skin hypersensitivity to adhesives.
• Previous or current clinically significant impulse control disorder, as determined by clinical interview.
• Anticipated change in psychiatric or neurologic status likely to require adjustment of CNS-active medications during the study period.
• Unwillingness of subject to remain on stable doses of CNS-active medications.
• Unwillingness of subject to refrain from as-needed use of RLS medications.
• Significant risk for suicide by clinical interview.

Sponsors & Collaborators

• John Winkelman, MD, PhD: lead
• UCB Pharma: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: Dr. John W. Winkelman
• Organization: Massachusetts General Hospital

jwwinkelman@partners.org

617-643-9101

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Sleep Disorders Clinical Research Program

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 6, 2013
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 29, 2016
• Results First Posted: October 13, 2016

Record last verified: 2016-10

Locations

US (1)