NCT00389831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 4, 2009

Completed
Last Updated

October 2, 2014

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

October 17, 2006

Results QC Date

July 28, 2009

Last Update Submit

September 24, 2014

Conditions

Restless Legs Syndrome

Keywords

RotigotineRotigotine nasal sprayEfficacy, safety and tolerabilityRestless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

  • Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo

    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.

    4 hours post-treatment period at each treatment day

  • Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.

    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.

    4 hours post-treatment period at each treatment day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo Nasal Spray

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

Drug: Rotigotine Nasal Spray

Interventions

Rotigotine Nasal SprayDRUG

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

Also known as: SPM937
Rotigotine Nasal Spray
Placebo Nasal SprayOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

You may not qualify if:

  • Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schwarz BioSciences GmbH

Monheim, Germany

Location

Related Links

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB Pharma
+1 877 822 9493

Study Officials

  • Marianne Raetz

    Schwarz BioSciences GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

August 1, 2006

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

October 2, 2014

Results First Posted

September 4, 2009

Record last verified: 2011-02

Locations

DE(1)