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

Restless Legs Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389831
• Other study ID #: SP0879
• Secondary ID: 2006-001937-17
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: September 24, 2014
• Start date: August 2006
• Est. completion date: December 2006

Study information

• Verified date: February 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Schwarz BioSciences GmbH	Monheim

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No

External Links

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