Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Phase 4

Completed

• Conditions: Restless Legs Syndrome (RLS)
• Interventions: Drug: Gabapentin enacarbil

• Registration Number: NCT01981941
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2013-11-05
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Primary Completion: 2015-05-13
• Study Completion: 2015-05-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Gabapentin enacarbil	Oral

Primary Outcome Measures

Name	Time	Method
Change in International Restless Leg Syndrome (IRLS) rating scale score	Baseline and at 4 week of the treatment (or at discontinuation)

Secondary Outcome Measures

Name	Time	Method
Change in Patient-related clinical global impression (PCGI) score	Baseline and at 4 week of the treatment (or at discontinuation)	Baseline and at 4 week of the treatment (or at discontinuation)
Change in Investigator-rated clinical global impression (ICGI) score	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	Up to 5 weeks
Plasma gabapentin concentration	Up to 5 weeks