To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
This study is a multicenter, non-blinded, non-comparative study. Patients who meet the eligible criteria will undergo one week observation period followed by four week treatment period. In treatment period, patients will receive gabapentin enacarbil orally one daily after dinner. After the four-week treatment period with gabapentin enacarbil, a one-week post-observation period will be undertaken.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
Change in International Restless Leg Syndrome (IRLS) rating scale score
Time frame: Baseline and at 4 week of the treatment (or at discontinuation)
Change in Investigator-rated clinical global impression (ICGI) score
Time frame: Baseline and at 4 week of the treatment (or at discontinuation)
Change in Patient-related clinical global impression (PCGI) score
Baseline and at 4 week of the treatment (or at discontinuation)
Time frame: Baseline and at 4 week of the treatment (or at discontinuation)
Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale
Time frame: Up to 5 weeks
Plasma gabapentin concentration
Time frame: Up to 5 weeks
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