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.)

Restless Legs Syndrome Clinical Trial

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.)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152958
• Other study ID #: 248.546
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: November 18, 2013
• Start date: January 2004

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	emovis GmbH	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to target event (CGI-I rating in association with RLSRS score above 15, period 2) for full analysis set		from randomization up to 3 months	No
Secondary	Time to target event for per protocol set (period 2)		from randomization up to 3 months	No
Secondary	Number of target events (period 2)		from randomization up to 3 months	No
Secondary	Change from baseline (visit 10) in the total score of Restless Legs Syndrome Rating Scale for Severity (RLSRS) (period 2)		from randomization up to 3 months	No
Secondary	Clinical Global Impressions - Global Improvement (period 2)		from randomization up to 3 months	No
Secondary	Change from baseline (visit 10) in Clinical Global Impressions - Severity of illness score (CGI-S) by 2 or more categories (period 2)		from randomization up to 3 months	No
Secondary	Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 2)		from randomization up to 3 months	No
Secondary	Clinical Global Impressions - Side Effects (CGI-SE) (period 2)		from randomization up to 3 months	No
Secondary	Change in Patient global impression (PGI) (period 2)		from randomization up to 3 months	No
Secondary	Change from baseline (visit 10) in Johns Hopkins Quality of Life (RLS-QoL) score (period 2)		from randomization up to 3 months	No
Secondary	Change from baseline (visit 10) in Visual analogue scales (RLS-VASs) for assessment of RLS symptoms (period 2)		from randomization up to 3 months	No
Secondary	Change from baseline (visit 10) in Epworth sleepiness scale (ESS)		from randomization up to 3 months	Yes
Secondary	Change from baseline (visit 2) in Augmentation severity rating scale of IRLSSG (ASRS) (period 2)		up to 9 months	Yes
Secondary	Change from baseline ASRS (period 1)		up to 6 months	Yes
Secondary	Change from baseline in the total score of RLSRS (period 1)		up to 6 months	No
Secondary	RLSRS responder status by visit (non-responder, partial responder, responder) (period 1)		after 6 months	No
Secondary	RLSRS responder status for patients who discontinued the study prematurely in period 1 by reason for discontinuation (period 1)		up to 6 months	No
Secondary	Clinical Global Impressions - Global Improvement (period 1)		6 months	No
Secondary	Clinical Global Impressions - Severity of illness score (CGI-S) (period 1)		6 months	No
Secondary	Clinical Global Impressions - Therapeutic Effect (CGI-TE) (period 1)		6 months	No
Secondary	Clinical Global Impressions - Side Effects (CGI-TE) (period 1)		6 months	No
Secondary	Change in patient global impression from baseline (period 1)		6 months	No
Secondary	Change from baseline in Johns Hopkins Quality of Life (RLS-QoL) score (period 1)		6 months	No
Secondary	Change from baseline in RLS-VASs (period 1)		6 months	No
Secondary	Change from baseline in ESS		6 months	Yes

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