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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01981941
First received: November 6, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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 Intervention Phase
Restless Legs Syndrome (RLS)
Drug: Gabapentin enacarbil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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―

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in International Restless Leg Syndrome (IRLS) rating scale score [ Time Frame: Baseline and at 4 week of the treatment (or at discontinuation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Investigator-rated clinical global impression (ICGI) score [ Time Frame: Baseline and at 4 week of the treatment (or at discontinuation) ] [ Designated as safety issue: No ]
  • Change in Patient-related clinical global impression (PCGI) score [ Time Frame: Baseline and at 4 week of the treatment (or at discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 5 weeks ] [ Designated as safety issue: No ]
  • Plasma gabapentin concentration [ Time Frame: Up to 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Drug: Gabapentin enacarbil
Oral

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981941

Contacts
Contact: Clinical Development Administration Dept. clintrialtrials_info@jp.astellas.com

Locations
Japan
Recruiting
Chubu, Japan
Recruiting
Chugoku, Japan
Recruiting
Kansai, Japan
Recruiting
Kanto, Japan
Recruiting
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Principal Investigator: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01981941     History of Changes
Other Study ID Numbers: 8825-CL-0103
Study First Received: November 6, 2013
Last Updated: November 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Restless Legs Syndrome
Renal Insufficiency
Psychomotor Agitation
Syndrome
Kidney Diseases
Urologic Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Disease
Pathologic Processes
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents

ClinicalTrials.gov processed this record on September 22, 2014