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

UCB

Status and phase: Completed; Phase 2

Conditions: Restless Legs Syndrome

Treatments: Drug: Rotigotine Nasal Spray; Other: Placebo Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389831

SP0879

2006-001937-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects receiving a single dose of placebo nasal spray on all 4 treatment days

Treatment:

Other: Placebo Nasal Spray

Rotigotine Nasal Spray

Experimental group

Description:

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

Treatment:

Drug: Rotigotine Nasal Spray