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

UCB Pharma44 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Restless Legs Syndrome

Interventions

Rotigotine Nasal SprayDRUG

Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution

Placebo Nasal SprayOTHER

Daily single dose of placebo delivered as single puff of nasal spray solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Schwarz BioSciences GmbH

Monheim, Germany

Outcomes

Primary Outcomes

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.

Time frame: 4 hours post-treatment period at each treatment day

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.

Time frame: 4 hours post-treatment period at each treatment day

Data from ClinicalTrials.gov

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