Clinical trial NCT01981941: Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
Official title: Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Restless Legs Syndrome (RLS)
Keywords: Gabapentin
Restless legs syndrome (RLS)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with restless legs syndrome (RLS) according to the international RLS Study Group Diagnostic Criteria
* Patients whose score is 15 or greater on the International RLS (IRLS) Rating Scale on the first day of the pre-observation period.
* Patients whose creatinine clearance level at the first day of pre-observation period is ≥30 mL/min to \<60mL/min estimated by Cockcroft-Gaul t equation
* Patients who provide written consent

Exclusion Criteria:

* Patients with sleep disorder such as sleep apnea syndrome, which affects the RLS evaluation
* Patients with history of augmentation and treatment rebound of RLS symptoms when using dopamine agonis
* Patients with neuropathy and movement disorder (diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesia, rheumatoid arthritis etc)
* Patients with uncontrolled diabetes \[HbA1c\>7.5% (NGSP value), in the past six months\], iron deficiency anemia, or drug administration of hypnotic sedatives.
* Patients who attempted suicide within six months prior to the consent obtained, or who have been diagnosed as a suicide risk by investigator or sub-investigator
* Patients with moderate or severe depression
* Patients with alcohol dependence or drug intoxication or who have a history of abuse or drug dependence in the past one year
* Patients whose job is shift work, professional driver, or engaging in hazardous activities such as operating machinery
* Patients with history of hypersensitivity to gabapentin
* Patients who have experience to participate in other post-marketing clinical studies or clinical trials within 12 weeks prior to the start of pre-observation
* Others: patients who are concluded to be ineligible by an investigator or sub-investigator as ineligible

Primary outcomes:
measure: Change in International Restless Leg Syndrome (IRLS) rating scale score
timeFrame: Baseline and at 4 week of the treatment (or at discontinuation)
Secondary outcomes:
measure: Change in Investigator-rated clinical global impression (ICGI) score
timeFrame: Baseline and at 4 week of the treatment (or at discontinuation)
measure: Change in Patient-related clinical global impression (PCGI) score
timeFrame: Baseline and at 4 week of the treatment (or at discontinuation)
measure: Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale
timeFrame: Up to 5 weeks
measure: Plasma gabapentin concentration
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References: