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

Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome (RLS)
• Intervention / Treatment: Drug: Gabapentin enacarbil

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Chugoku, Japan
  • Kansai, Japan
  • Kanto, Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Oral	Drug: Gabapentin enacarbil; Oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigator-rated clinical global impression (ICGI) score		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)	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Principal Investigator: Medical Director, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2013
• Primary Completion (Actual): May 13, 2015
• Study Completion (Actual): May 13, 2015

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimated): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Gabapentin; Restless legs syndrome (RLS)
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Behavioral Symptoms; Disease; Neurobehavioral Manifestations; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Gabapentin
• Other Study ID Numbers: 8825-CL-0103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.