A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Idiopathic Restless Legs Syndrome

Treatments: Drug: Pramipexole 0.125 mg tablet; Drug: Pramipexole 0.5 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390689

248.627

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 3 patient groups

Pramipexole 0.25 mg once daily

Experimental group

Description:

Pramipexole 0.25 mg given once daily

Treatment:

Drug: Pramipexole 0.125 mg tablet

Pramipexole 0.5 mg once daily

Experimental group

Description:

Pramipexole 0.5 mg given once daily

Treatment:

Drug: Pramipexole 0.5 mg tablet

Pramipexole 0.75 mg once daily

Experimental group

Description:

Pramipexole 0.75 mg given once daily

Treatment:

Drug: Pramipexole 0.125 mg tablet

Drug: Pramipexole 0.5 mg tablet