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Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00356096
First received: July 24, 2006
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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, after 12 weeks of treatment


Condition Intervention Phase
Restless Legs Syndrome
Depression
Drug: pramipexole
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate [ Time Frame: 12 weeks ]

Enrollment: 404
Study Start Date: July 2006
Primary Completion Date: June 2007 (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:

  1. Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
  2. Male or female out-patients aged 18-80 years.
  3. 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:

    An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs) The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).

  4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
  5. In addition all of the following must be demonstrated at Visit 2 (baseline):

IRLS total score >15 A score of >=2 for item 10 of the IRLS rating scale

Exclusion Criteria:

  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 investigatos 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 investigators 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
  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: NCT00356096

  Show 54 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00356096     History of Changes
Other Study ID Numbers: 248.604
Study First Received: July 24, 2006
Last Updated: May 18, 2012
Health Authority: Finland: Finnish Medicines Agency
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte
Great Britain: MHRA
Ireland: The Irish Medicines Board
Italy: Comitato Etico Indipendente dell'Az. USL di Bologna - Bologna
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on November 19, 2014