Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Trial to Assess the Efficacy, Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome

The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Other: Placebo Nasal Spray; Drug: Rotigotine Nasal Spray

Detailed Description

Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Monheim, Germany
    • Schwarz BioSciences GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

Exclusion Criteria:

• Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects receiving a single dose of placebo nasal spray on all 4 treatment days	Other: Placebo Nasal Spray; Daily single dose of placebo delivered as single puff of nasal spray solution
Experimental: Rotigotine Nasal Spray; Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4	Drug: Rotigotine Nasal Spray; Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution; Other Names: SPM937

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo	Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.	4 hours post-treatment period at each treatment day
Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.	The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.	4 hours post-treatment period at each treatment day

Collaborators and Investigators

• Sponsor: UCB Pharma
• Investigators: Study Director: Marianne Raetz, Schwarz BioSciences GmbH

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 17, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (Estimate): October 19, 2006

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: September 24, 2014
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Restless Legs Syndrome; Rotigotine; Rotigotine nasal spray; Efficacy, safety and tolerability
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0879; 2006-001937-17 (EudraCT Number)