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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.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00356096
  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, af ter 12 weeks of treatment


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

MedlinePlus related topics: Depression Restless Legs
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

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

Estimated Enrollment: 367
Estimated Study Completion Date: June 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356096

  Show 54 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Italy
  More Information

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009