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
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Rotigotine Nasal Spray
Other: Placebo Nasal Spray
Phase 2

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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: August 2006
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SPM937

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389831

Locations
Germany
Schwarz BioSciences GmbH
Monheim, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Marianne Raetz Schwarz BioSciences GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00389831     History of Changes
Other Study ID Numbers: SP879
Study First Received: October 17, 2006
Results First Received: July 28, 2009
Last Updated: August 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
Rotigotine nasal spray
Efficacy, safety and tolerability
Restless Legs Syndrome

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014