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

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ClinicalTrials.gov Identifier: NCT00389831
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : September 4, 2009
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Rotigotine Nasal Spray Other: Placebo Nasal Spray Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2006
Primary Completion Date : November 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389831


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

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00389831     History of Changes
Other Study ID Numbers: SP0879
2006-001937-17 ( EudraCT Number )
First Posted: October 19, 2006    Key Record Dates
Results First Posted: September 4, 2009
Last Update Posted: October 2, 2014
Last Verified: February 2011

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

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