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

Astellas

Status and phase

Completed

Phase 4

Conditions

Restless Legs Syndrome (RLS)

Treatments

Drug: Gabapentin enacarbil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981941

8825-CL-0103

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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