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

Restless Legs Syndrome (RLS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981941
• Other study ID #: 8825-CL-0103
• Status: Completed
• Phase: Phase 4
• Start date: November 5, 2013
• Est. completion date: May 13, 2015

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 13, 2015
• Est. primary completion date: May 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Renal Insufficiency
• Restless Legs Syndrome
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

Drug:
• Gabapentin enacarbil
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Restless Leg Syndrome (IRLS) rating scale score		Baseline and at 4 week of the treatment (or at discontinuation)
Secondary	Change in Investigator-rated clinical global impression (ICGI) score		Baseline and at 4 week of the treatment (or at discontinuation)
Secondary	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)
Secondary	Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale		Up to 5 weeks
Secondary	Plasma gabapentin concentration		Up to 5 weeks

External Links

•   Link to results on Astellas Clinical Study Results website