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.)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00152958
First received: September 8, 2005
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to target event for per protocol set (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • Number of target events (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Global Improvement (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Side Effects (CGI-SE) (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • Change in Patient global impression (PGI) (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline (visit 10) in Epworth sleepiness scale (ESS) [ Time Frame: from randomization up to 3 months ] [ Designated as safety issue: Yes ]
  • Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2) [ Time Frame: up to 9 months ] [ Designated as safety issue: Yes ]
  • Change from baseline ASRS (period 1) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in the total score of RLSRS (period 1) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • RLSRS responder status by visit (non-responder, partial responder, responder) (period 1) [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Global Improvement (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity of illness score (CGI-S) (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Side Effects (CGI-TE) (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in patient global impression from baseline (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in RLS-VASs (period 1) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in ESS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 224
Study Start Date: January 2004
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152958

Locations
Germany
emovis GmbH
Berlin, Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Clinpharm International GmbH & Co. KG
Berlin (Hellersdorf), Germany
Boehringer Ingelheim Investigational Site
Chemnitz, Germany
ClinPharm Internat. GmbH & Co. KG
Görlitz, Germany
Paracelsus-Elena-Klinik
Kassel, Germany
ClinPharm International GmbH & Co. KG
Leipzig, Germany
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg, Germany
Universitätsklinikum Giessen und Marburg
Marburg, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Boehringer Ingelheim Investigational Site
Würzburg, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00152958     History of Changes
Other Study ID Numbers: 248.546
Study First Received: September 8, 2005
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014