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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 May 2012 |
Main ID: |
EUCTR2008-005889-32-SE |
Date of registration:
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11/05/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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RANDOMIZED, DOUBLE-BLIND, 12-MONTH STUDY OF PREGABALIN IN
SUBJECTS WITH RESTLESS LEGS SYNDROME - n/a
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Scientific title:
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RANDOMIZED, DOUBLE-BLIND, 12-MONTH STUDY OF PREGABALIN IN
SUBJECTS WITH RESTLESS LEGS SYNDROME - n/a |
Date of first enrolment:
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17/07/2009 |
Target sample size:
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750 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005889-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Finland
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects must meet the following criteria to be eligible to participate in the study: 1. Diagnosis of RLS is to be made by a Physician with experience and/or training in RLS. Idiopathic RLS with the presence of all four clinical manifestations of RLS: • Urge to move the legs usually with dysesthesias: 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); • Onset or exacerbation with rest: The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; • Relief with movement: The urge to move or unpleasant sensations are partially or totally relieved by movements, such as walking or stretching, at least as long as the activity continues; • Circadian pattern: 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); • The following instruments will be utilized to aid the diagnosis: • Medical history and/or RLS treatment history. • Cambridge-Hopkins Restless Legs Syndrome Short Form Diagnostic Questionnaire (RLS-SFDQ-9) – entered by the subjects. • RLS-Clinical Diagnostic Interview (RLS CDI) – conducted and signed-off by the Investigator. 2. RLS symptoms must occur predominantly in the evening (between the hours of 17:00 to 07:00). 3. A history or the presence of RLS symptoms for at least 6 months. 4. An International Restless Leg Scale (IRLS) total score =15 at beginning of placebo run-in (1 week prior to Baseline) and end of placebo run-in (Baseline). 5. Have =15 nights with RLS symptoms in the month prior to Screening. Subjects receiving RLS therapy at the time of Screening are to have had =15 nights per month with RLS symptoms prior to initiation of this treatment. Have =2 nights with RLS symptoms during the week of placebo run-in. 6. Both genders. Age 18 years or older. 7. Evidence of a personally signed and dated Informed Consent Document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Subjects may not participate in the study if they meet any of the following criteria: 1. Any secondary form of RLS which is primarily attributable to other conditions, eg, end stage renal disease, iron-deficiency anemia. 2. Current augmentation due to RLS treatment, or pramipexole-caused clinically significant augmentation within 6 weeks of the Screening Visit. Clinically significant augmentation is defined as the subject experiences symptoms that are severe enough to impact the subject’s daily life and/or requires an alteration of treatment, eg, change to another class of medication. 3. Requiring regular (more than 2 times a week within 3 months of screening visit) medication treatment for daytime RLS symptoms (between the hours of 07:00 to 17:00). 4. Placebo responders as defined by a >50% improvement in RLS symptoms, ie, decrease of the total score in IRLS Scale between beginning of placebo run in (1 week prior to Baseline) and end of placebo run-in (Baseline Visits). 5. Any symptomatic neuropathies or current diagnosis of clinically relevant concomitant conditions that may confound clinical assessments of RLS and/or severe enough to disturb sleep, for example, painful leg and moving toes syndrome. 6. Clinically significant lumbar radiculopathy or central spinal stenosis by history or examination. 7. Presence of severe central nervous degenerative diseases such as Parkinson’s disease, dementia, progressive supranuclear paresthesia, multisystem atrophy, Huntington Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease. 8. History or presence of a severe sleep disorder, especially those with difficulty falling and/or staying asleep, that may confound assessments (Apnea/Hypopnea Index greater than 20 if a sleep study has been previously performed) at the Screening or Baseline Visits. With mild to moderate sleep apnea, a subject may be eligible to participate the study. However, an AHI must be <20 without aid of continuous positive airway pressure therapy (CPAP) if a sleep study has been previously performed. 9. Use of medications likely to influence sleep architecture or motor manifestations during sleep prior to the Baseline Visit (BL) without an appropriate washout period. Refer to Appendix 1 for the list of exclusionary medications. These include neuroleptics, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants, psychostimulantmedications, barbiturates and opioids. Note: Use of serotonin selective reuptake inhibitor (SSRI) antidepressants at a stable dose for minimum 6 months prior to Screening are allowed to enter the study, if discontinuation is determined against the subject's well being. However, subject must be able to sustain the same treatment and dose level throughout the trial per investigator's discretion. Use of selective (serotonin) norepinephrine reuptake inhibitor (SNRI) is not permitted during the study. 10. Clinically significant liver disease, or an elevation in either bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) levels >3 times the upper limit of normal value (ULN). 11. Clinically significant renal disease, or creatinine clearance level <60 mL/min (estimated by Cockroft Gault method). 12. Any other clinically significant condition (eg, cardiac dysfunction, active neoplasm, uncorrected hypothyroidism or hyperthyroidism) or laboratory assay abnormality. 13. Failure to respond positively to dopaminergic agents, gabapentin or pregabalin in treating RLS acc
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Restless Legs Syndrome MedDRA version: 9.1
Level: LLT
Classification code 10058920
Term: Restless legs syndrome
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Intervention(s)
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Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148-553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-3-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148-553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-3-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Lyrica Pharmaceutical Form: Capsule* INN or Proposed INN: Pregabalin CAS Number: 148-553-50-8 Current Sponsor code: Lyrica Other descriptive name: (s)-3-(aminomethyl)-5-methylhexanoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Sifrol Pharmaceutical Form: Capsule* INN or Proposed INN: Pramipexole Dihydrochloride, Premipexole Dihydrochloride Monohydrate, Pramipexole salt CAS Number: 104632-26-0 Current Sponsor code: Sifrol Other descriptive name: (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
Trade Name: Sifrol Pharmaceutical Form: Capsule* INN or Proposed INN: Pramipexole Dihydrochloride, Premipexole Dihydrochloride Monohydrate, Pramipexole salt CAS Number: 104632-26-0 Current Sponsor code: Sifrol Other descriptive name: (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate Concentratio
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Primary Outcome(s)
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Main Objective: • To assess the efficacy of a fixed dose of pregabalin to placebo during the first 12 week treatment period in subjects with RLS. • To compare the rate of augmentation of a fixed dose of pregabalin to 2 fixed doses of pramipexole over 9 or 12 months in subjects with RLS.
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Primary end point(s): All analyses for the primary and secondary endpoints will be conducted for the Intent-to-Treat (ITT) population, which is the set of randomized subjects who take at least one dose of study medication and have at least one post-randomization efficacy assessment.
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Secondary Objective: To assess the comparability of efficacy of pregabalin and pramipexole in treating symptoms of RLS with pregabalin or pramipexole during the first 12wks and beyond through end of the study •To assess the severity of augmentation associated with pregabalin or pramipexole treatment •To assess the tolerability and safety of pregabalin and pramipexole treatment over 1yr •To assess the impact of pregabalin and pramipexole treatment on subjective sleep parameters over 1yr •To assess the impact of pregabalin and pramepexol treatment on next day impact over 1yr •To assess the impact of pregabalin and pramepexol treatment on mood as compared to placebo during the first 12wks •To assess the impact of pregabalin and pramipexole treatment on quality of life over 1yr •To assess the impact of pregabalin and pramipexole treatment on limb pain during the first 12wks •To assess the impact of pregabalin and pramipexole treatment on work productivity and activity impairment over 1yr
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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