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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01981941
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome (RLS) Drug: Gabapentin enacarbil Phase 4

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  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-marketing Clinical Study of Gabapentin Enacarbil ―Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment―
Study Start Date : May 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Experimental: Treatment group
Drug: Gabapentin enacarbil

Primary Outcome Measures :
  1. 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 Measures :
  1. Change in Investigator-rated clinical global impression (ICGI) score [ Time Frame: Baseline and at 4 week of the treatment (or at discontinuation) ]
  2. Change in Patient-related clinical global impression (PCGI) score [ Time Frame: Baseline and at 4 week of the treatment (or at discontinuation) ]
    Baseline and at 4 week of the treatment (or at discontinuation)

  3. Safety assessed by the incidence of adverse events, vital signs, labo-tests, body weight and Epworth sleepiness scale [ Time Frame: Up to 5 weeks ]
  4. Plasma gabapentin concentration [ Time Frame: Up to 5 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01981941

Chubu, Japan
Chugoku, Japan
Kansai, Japan
Kanto, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Principal Investigator: Medical Director Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01981941     History of Changes
Other Study ID Numbers: 8825-CL-0103
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Astellas Pharma Inc:
Restless legs syndrome (RLS)

Additional relevant MeSH terms:
Renal Insufficiency
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators