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A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00349531
  Purpose

The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturba nce of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Phase IV

MedlinePlus related topics: Restless Legs Sleep Disorders
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 Pramipexole (Sifrol?, Mirapexin?) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-Patients With Idiopathic Restless Legs Syndrome

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Primary endpoint: change from baseline after 12 weeks in IRLS total score. Co-primary endpoint: change from baseline after 12 weeks in MOS sleep disturbance score.

Secondary Outcome Measures:
  • Secondary endpoints: CGI-I and IRLS responder rate other MOS dimensions, RLS-6 items 4-6, IRLS item 10, VAS ,Verbal Fluency Tests ,RLS-QoL scores PGI responder rate adverse event profile, systolic and diastolic blood pressure, pulse rate

Estimated Enrollment: 320
Estimated Study Completion Date: May 2007
Detailed Description:

The primary objective of this study is to investigate the effects on RLS symptoms (based on IRLS) an d sleep disturbance (based on MOS sleep scale) of pramipexole 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome (RLS). Secondary objectives are to investigate the effects on clinical global impressions-global improvemen t (based on CGI-I responder rate), RLS (based on IRLS responder rate), other MOS dimensions (based o n MOS sleep scale), daytime symptoms (based on items 4-6 of the RLS-6 scales), associated mood distu rbance (based on item 10 of the IRLS scale), pain in limbs (based on a visual analogue scale), cogni tive function (based on verbal fluency tests), quality of life in RLS (based on Johns Hopkins RLS-Qo L questionnaire), patient global impression (based on PGI responder rate) and safety (based on AE pr ofile) of pramipexole 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 safety and efficacy of pramipexole o n RLS symptoms and on RLS-associated sleep disturbances from which the majority of RLS patients suffer. The study will therefore explore the role and efficacy o f pramipexole in RLS patients with concomitant sleep disturbances and may benefi t nearly all RLS patients.

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. IRLS total score >15 at baseline (Visit 2).

1.Women of child-bearing potential who do not use during the trial an adequate method of contraception.2.Women of child-bearing potential not having negative pregnancy test at screening.3.Breastfeeding women.4.Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.5.All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.6.Withdrawal symptoms.7.Pramipexole non-responders in other indications than RLS.8.Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.9.Diabetes mellitus requiring insulin therapy.10.Any of the following laboratory results at screening: any clinically significant abnormalities in laboratory parameters;haemoglobin below LLN.11.Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.12.Clinically significant hepatic disease or GPT >2 times the ULN.13.Serum ferritin <10 ng/mL.14.History of/or malignant melanoma.15.History of/or clinically significant vision abnormalities.16.History of/or any other sleep disorder (other than RLS-related).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.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 2 years).20.Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.21.Participation in an investigational drug study within one month.22.Any clinically significant conditions that would interfere or constitute a health hazard for the patient.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349531

  Show 49 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Italy
  More Information

Study ID Numbers: 248.615
Study First Received: July 6, 2006
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00349531  
Health Authority: Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) di Milano;   Ireland: The Irish Medicines Board;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte;   Norway: Norwegian Medicines Agency (Statens Legemiddelverk);   Spain: Agencia Espanola del Medicamento y Productos Sanitarios;   Sweden: Medical Products Agency;   Great Britain: MHRA

Study placed in the following topic categories:
Ekbom syndrome
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dyskinesias
Pramipexol
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 14, 2009