---
title: Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
nct_id: NCT00389831
overall_status: COMPLETED
phase: PHASE2
sponsor: UCB Pharma
study_type: INTERVENTIONAL
primary_condition: Restless Legs Syndrome
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00389831.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00389831"
ct_last_update_post_date: 2014-10-02
last_seen_at: "2026-05-12T06:24:35.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

**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

**NCT ID:** [NCT00389831](https://clinicaltrials.gov/study/NCT00389831)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** UCB Pharma
- **Conditions:** Restless Legs Syndrome
- **Start Date:** 2006-08
- **Completion Date:** 2006-12
- **CT.gov Last Update:** 2014-10-02

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Placebo** (PLACEBO_COMPARATOR) — Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
- **Rotigotine Nasal Spray** (EXPERIMENTAL) — 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

- **Rotigotine Nasal Spray** (DRUG) — Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution
- **Placebo Nasal Spray** (OTHER) — Daily single dose of placebo delivered as single puff of nasal spray solution

## Primary Outcomes

- **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.
- **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.

## Locations (1)

- Schwarz BioSciences GmbH, Monheim, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.schwarz biosciences gmbh|monheim||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00389831.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00389831*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*