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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00389831
First received: October 17, 2006
Last updated: August 30, 2011
Last verified: February 2011

October 17, 2006
August 30, 2011
August 2006
November 2006   (final data collection date for primary outcome measure)
  • Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo [ Time Frame: 4 hours post-treatment period at each treatment day ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 hours post-treatment period at each treatment day ] [ Designated as safety issue: No ]
    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.
PLMWI decrease
Complete list of historical versions of study NCT00389831 on ClinicalTrials.gov Archive Site
Not Provided
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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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: Rotigotine Nasal Spray
    Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
    Other Name: SPM937
  • Other: Placebo Nasal Spray
    Daily single dose of placebo delivered as single puff of nasal spray solution
  • Placebo Comparator: Placebo
    Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
    Intervention: Other: Placebo Nasal Spray
  • 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
    Intervention: Drug: Rotigotine Nasal Spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00389831
SP879
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: Marianne Raetz Schwarz BioSciences GmbH
UCB, Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP