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

NCT01981941 | Completed Phase 4

• 1 other identifier: 8825-CL-0103
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

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.

Conditions

Restless Legs Syndrome (RLS)

Keywords

Gabapentin; Restless legs syndrome (RLS)

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

• 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)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

Oral

Drug: Gabapentin enacarbil

Interventions

Gabapentin enacarbil DRUG

Oral

Treatment group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Medical Director

  Astellas Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: November 5, 2013
• Primary Completion: May 13, 2015
• Study Completion: May 13, 2015
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)