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

Phase 2

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Rotigotine Nasal Spray; Other: Placebo Nasal Spray

• Registration Number: NCT00389831
• Lead Sponsor: UCB Pharma

Brief Summary

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.

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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Primary Completion: 2006-11
• Study Completion: 2006-12
• Results First Submitted: 2009-07-28
• Results First Submitted QC: 2009-07-28
• Results First Posted: 2009-09-04
• Status Verified: 2011-02
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotigotine Nasal Spray	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
Placebo	Placebo Nasal Spray	Subjects receiving a single dose of placebo nasal spray on all 4 treatment days

Primary Outcome Measures

Name	Time	Method
Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo	4 hours post-treatment period at each treatment day	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.
Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.	4 hours post-treatment period at each treatment day	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.

Trial Locations

Locations (1)

Schwarz BioSciences GmbH; 🇩🇪 Monheim, Germany