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

Primary Purpose

Restless Legs Syndrome (RLS)

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Gabapentin enacarbil

About this trial

This is an interventional treatment trial for Restless Legs Syndrome (RLS) focused on measuring Gabapentin, Restless legs syndrome (RLS)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Oral

Outcomes

Primary Outcome Measures

Change in International Restless Leg Syndrome (IRLS) rating scale score

Secondary Outcome Measures

Change in Investigator-rated clinical global impression (ICGI) score

Change in Patient-related clinical global impression (PCGI) 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

Plasma gabapentin concentration

Full Information

NCT ID

NCT01981941

First Posted

November 6, 2013

Last Updated

January 23, 2019

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01981941

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 5, 2013 (Actual)

Primary Completion Date

May 13, 2015 (Actual)

Study Completion Date

May 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome (RLS)

Keywords

Gabapentin, Restless legs syndrome (RLS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

Gabapentin enacarbil

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Change in International Restless Leg Syndrome (IRLS) rating scale score

Time Frame

Baseline and at 4 week of the treatment (or at discontinuation)

Secondary Outcome Measure Information:

Title

Change in Investigator-rated clinical global impression (ICGI) score

Time Frame

Baseline and at 4 week of the treatment (or at discontinuation)

Title

Change in Patient-related clinical global impression (PCGI) score

Description

Baseline and at 4 week of the treatment (or at discontinuation)

Time Frame

Baseline and at 4 week of the treatment (or at discontinuation)

Title

Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale

Time Frame

Up to 5 weeks

Title

Plasma gabapentin concentration

Time Frame

Up to 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Principal Investigator

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyushu

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Links:

URL

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=147

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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