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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

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
• Actual Primary Completion Date: November 2006
• Actual Study Completion Date: December 2006

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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

Locations

Germany

Schwarz BioSciences GmbH

Monheim, Germany

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: Marianne Raetz; Schwarz BioSciences GmbH

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00389831
• Other Study ID Numbers: SP0879; 2006-001937-17 ( EudraCT Number )
• First Posted: October 19, 2006
• 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:

Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Disease; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; 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