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A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pramipexole
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female out-patients aged 18-80 Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group RLSRS score > 15 RLS symptoms present at least 2 to 3 days per week within the last 3 months Written informed consent Exclusion Criteria: Women of childbearing potential without adequate contraception, or breastfeeding Concomitant or previous pharmacologically therapy of RLS Clinically significant renal disease, and/or hepatic disease Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures Presence of any sleep disorder History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction History of or clinical signs of malign neoplasm Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated Allergic to pramipexole or its excipients

Sites / Locations

  • Clinpharm International GmbH & Co. KG
  • Boehringer Ingelheim Investigational Site
  • Charité Campus Virchow-Klinikum
  • emovis GmbH
  • Boehringer Ingelheim Investigational Site
  • ClinPharm Internat. GmbH & Co. KG
  • Paracelsus-Elena-Klinik
  • ClinPharm International GmbH & Co. KG
  • Neurologische Klinik der Otto-von-Guericke-Universität
  • Universitätsklinikum Giessen und Marburg
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set

Secondary Outcome Measures

Time to target event for per protocol set (period 2)
Number of target events (period 2)
Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2)
Clinical Global Impressions - Global Improvement (period 2)
Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2)
Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2)
Clinical Global Impressions - Side Effects (CGI-SE) (period 2)
Change in Patient global impression (PGI) (period 2)
Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2)
Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2)
Change from baseline (visit 10) in Epworth sleepiness scale (ESS)
Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2)
Change from baseline ASRS (period 1)
Change from baseline in the total score of RLSRS (period 1)
RLSRS responder status by visit (non-responder, partial responder, responder) (period 1)
RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1)
Clinical Global Impressions - Global Improvement (period 1)
Clinical Global Impressions - Severity of illness score (CGI-S) (period 1)
Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1)
Clinical Global Impressions - Side Effects (CGI-TE) (period 1)
Change in patient global impression from baseline (period 1)
Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1)
Change from baseline in RLS-VASs (period 1)
Change from baseline in ESS

Full Information

First Posted
September 8, 2005
Last Updated
November 18, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00152958
Brief Title
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
Official Title
A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole. Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician's clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
224 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pramipexole
Primary Outcome Measure Information:
Title
Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set
Time Frame
from randomization up to 3 months
Secondary Outcome Measure Information:
Title
Time to target event for per protocol set (period 2)
Time Frame
from randomization up to 3 months
Title
Number of target events (period 2)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2)
Time Frame
from randomization up to 3 months
Title
Clinical Global Impressions - Global Improvement (period 2)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2)
Time Frame
from randomization up to 3 months
Title
Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2)
Time Frame
from randomization up to 3 months
Title
Clinical Global Impressions - Side Effects (CGI-SE) (period 2)
Time Frame
from randomization up to 3 months
Title
Change in Patient global impression (PGI) (period 2)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 10) in Epworth sleepiness scale (ESS)
Time Frame
from randomization up to 3 months
Title
Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2)
Time Frame
up to 9 months
Title
Change from baseline ASRS (period 1)
Time Frame
up to 6 months
Title
Change from baseline in the total score of RLSRS (period 1)
Time Frame
up to 6 months
Title
RLSRS responder status by visit (non-responder, partial responder, responder) (period 1)
Time Frame
after 6 months
Title
RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1)
Time Frame
up to 6 months
Title
Clinical Global Impressions - Global Improvement (period 1)
Time Frame
6 months
Title
Clinical Global Impressions - Severity of illness score (CGI-S) (period 1)
Time Frame
6 months
Title
Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1)
Time Frame
6 months
Title
Clinical Global Impressions - Side Effects (CGI-TE) (period 1)
Time Frame
6 months
Title
Change in patient global impression from baseline (period 1)
Time Frame
6 months
Title
Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1)
Time Frame
6 months
Title
Change from baseline in RLS-VASs (period 1)
Time Frame
6 months
Title
Change from baseline in ESS
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female out-patients aged 18-80 Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group RLSRS score > 15 RLS symptoms present at least 2 to 3 days per week within the last 3 months Written informed consent Exclusion Criteria: Women of childbearing potential without adequate contraception, or breastfeeding Concomitant or previous pharmacologically therapy of RLS Clinically significant renal disease, and/or hepatic disease Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures Presence of any sleep disorder History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction History of or clinical signs of malign neoplasm Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated Allergic to pramipexole or its excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Clinpharm International GmbH & Co. KG
City
Berlin (Hellersdorf)
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
Country
Germany
Facility Name
emovis GmbH
City
Berlin
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Chemnitz
Country
Germany
Facility Name
ClinPharm Internat. GmbH & Co. KG
City
Görlitz
Country
Germany
Facility Name
Paracelsus-Elena-Klinik
City
Kassel
Country
Germany
Facility Name
ClinPharm International GmbH & Co. KG
City
Leipzig
Country
Germany
Facility Name
Neurologische Klinik der Otto-von-Guericke-Universität
City
Magdeburg
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg
City
Marburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.546_U05-1532.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.546_literature.pdf
Description
Related Info

Learn more about this trial

A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)

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