Conditions: Restless Legs Syndrome
Keywords: Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: no

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.

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).

Arms:
arm 1: Subjects receiving a single dose of placebo nasal spray on all 4 treatment days arm 2: 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

Interventions: intervention 1: Rotigotine Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution intervention 2: Daily single dose of placebo delivered as single puff of nasal spray solution

Protocol document: