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.)

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Restless Legs Syndrome

Treatments

Drug: Pramipexole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152958

248.546

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No 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