A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Pramipexole 0.125 mg tablet; Pramipexole 0.5 mg tablet
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of double blind phase in this trial is to compare the efficacy and safety at
      the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label
      phase in this trial is to investigate the long term safety and efficacy of pramipexole in
      RLS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients between 20 and 80 years

          2. Patients with a diagnosis of restless legs syndrome (RLS) according to the following
             diagnosis criteria of National institute of health (NIH)/International restless legs
             syndrome study group (IRLSSG):

               1. An urge to move the legs, usually accompanied or caused by uncomfortable and
                  unpleasant sensations in the legs.

               2. The urge to move or unpleasant sensations begin or worsen during periods of rest
                  or inactivity such as lying or sitting.

               3. 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.

               4. 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.

          3. Patients with a total score larger than 15 on the IRLS at Visit 2

        Exclusion Criteria:

          1. Premenopausal women who meet any of the following 1) to 3) 1) Patients who are
             pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to
             become pregnant during the study period

          2. Patients who cannot take adequate contraceptive measures

          3. Patients with a history of akathisia induced by neuroleptics

          4. Patients with diabetes mellitus requiring insulin therapy

          5. Patients who are judged to have microcytic anaemia by the investigator or
             sub-investigator

          6. Patients with a history or signs of peripheral neuropathy, myelopathy, multiple
             sclerosis, Parkinson's disease or other neurological diseases that may result in the
             occurrence of secondary RLS in the physical function tests or neurological tests

          7. Patients with other sleep disorders such as abnormal behaviour during Rapid eye
             movement (REM) sleep, narcolepsy and sleep apnoea syndrome (patients with an
             apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the
             relevant trial site or those with loud snoring at least 5 nights/week and an
             experience of respiratory arrest during sleep or excessive daytime sleepiness)