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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00356096 |
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, af ter 12 weeks of treatment
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome Depression |
Drug: pramipexole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol?, Mirapexin?) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-Patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances |
Estimated Enrollment: | 367 |
Estimated Study Completion Date: | June 2007 |
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, ea ch defined as change from baseline after 12 weeks of treatment. Secondary objectives are the assessment of the effects on clinical global impressions-global improv ement, RLS, depressive symptoms, pain in limbs, sleep quality and severity of RLS symptoms, anxiety
, quality of life in RLS, patient global impression and safety, each defined as change from baseline in comparison to placebo. The expected duration of the screening period is 4-28 days, depending on the required wash-out from concomitant medications and each individual patients situation. The duration of the treatment period for individual patients is 12 weeks (+/-3 days). The duration of the follow-up period is 7 days (+/
-3 days). The total duration of patient participation is 14-17 weeks
Study Hypothesis:
This study has the potential to demonstrate efficacy and safety of pramipexole f or a large subgroup of RLS patients suffering from concomitant mood disturbances
. The study will therefore explore the role and efficacy of pramipexole in RLS p atients with underlying mood and / or anxiety disorders and benefit a large subg roup of RLS sufferers.
Comparison(s):
Placebo
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
In addition all of the following must be demonstrated at Visit 2 (baseline):
1. Women of child-bearing potential who do not use an adequate method of contraception 2. Any women of child-bearing potential not having negative pregnancy test at screening 3. Breastfeeding women 4. Concomitant or previous pharmacologic therapy for RLS 5. All treatment less than 14 days before baseline or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms 6. Withdrawal symptoms of any medication must not be present at baseline 7. Previous pramipexole non-responders in other indications than RLS. 8. Hypersensitivity to pramipexole or any other component of the investigational product 9. Diagnosis of diabetes mellitus requiring insulin 10. Any of the following laboratory results at screening: clinically significant abnormalities at the investigator?s discretion; Hb below lower limit of normal 11. Clinically significant renal disease at screening 12. Clinically significant hepatic disease at screening 13. Serum ferritin <10 ng/mL at screening. 14. History of/or malignant melanoma. 15. History of/or clinically significant vision abnormalities 16. History of/or any other sleep disorder 17. History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy, or BDI-II total score >28 18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator?s opinion 19. History of/or alcohol abuse or drug addiction within the last 2 years before screening 20. Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake cycle 21. Participation in an investigational drug study within one month prior to the start of this study 22. Patients with any clinically significant conditions that in the opinion of the investigator
Study Chair: | Boehringer Ingelheim Study Coordinator | BI Italy |
Study ID Numbers: | 248.604 |
Study First Received: | July 24, 2006 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00356096 |
Health Authority: | United States of America: Food and Drug Administration; Great Britain: MHRA; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte; Italy: Comitato Etico Indipendente dell'Az. USL di Bologna - Bologna; Finland: National Agency for Medicines; Sweden: Medical Products Agency; Ireland: The Irish Medicines Board; Korea, Republic of: Korea Food and Drug Administration (KFDA); France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Spain: Agencia Espanola del Medicamento y Productos Sanitarios |
Depression Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Depressive Disorder Dyskinesias Pramipexol |
Behavioral Symptoms Sleep Disorders, Intrinsic Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Parasomnias Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Psychomotor Disorders Dopamine Agents Central Nervous System Agents |