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

NCT ID: NCT00389831

Last Updated: 2014-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Nasal Spray

Intervention Type OTHER

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

Rotigotine Nasal Spray

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

Group Type EXPERIMENTAL

Rotigotine Nasal Spray

Intervention Type DRUG

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

Interventions

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Rotigotine Nasal Spray

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

Intervention Type DRUG

Placebo Nasal Spray

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

Intervention Type OTHER

Other Intervention Names

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SPM937

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Raetz

Role: STUDY_DIRECTOR

Schwarz BioSciences GmbH

Locations

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Schwarz BioSciences GmbH

Monheim, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2006-001937-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0879

Identifier Type: -

Identifier Source: org_study_id

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