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

NCT00389831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-10-02

Study results available
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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.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Rotigotine Nasal Spray

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

OTHER

Placebo Nasal Spray

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • Marianne Raetz · Schwarz BioSciences GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-11-30
Completion
2006-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389831 on ClinicalTrials.gov