NCT00389831

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine Nasal Spray	Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
OTHER	Placebo Nasal Spray	Daily single dose of placebo delivered as single puff of nasal spray solution

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-11-01
• Completion: 2006-12-01
• First posted: 2006-10-19
• Last updated: 2014-10-02
• Results posted: 2009-09-04

Locations

1 site across 1 country: Germany