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Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

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.
 
ClinicalTrials.gov Identifier: NCT02658188
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: ASP8825 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Study Start Date : December 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Experimental: ASP8825 group Drug: ASP8825
Oral
Other Name: gabapentin enacarbil




Primary Outcome Measures :
  1. Change from baseline in IRLS score [ Time Frame: Baseline to Week 52 ]
    IRLS: International Restless Legs Syndrome Scale

  2. Safety assessed by Vital signs [ Time Frame: Up to Week 52 ]
    Blood pressure and pulse rate

  3. Safety assessed by Adverse Events [ Time Frame: Up to Week 52 ]
  4. Safety assessed by Laboratory tests [ Time Frame: Up to Week 52 ]
    Hematology, blood biochemistry, thyroid function test and urinalysis

  5. Safety assessed by 12-lead-electrocardiogram [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  1. Proportion of responders on ICGl of improvement [ Time Frame: Up to Week 52 ]
    ICGI: Investigator-rated Clinical Global Impression of improvement

  2. Proportion of responders on PCGI of improvement [ Time Frame: Up to Week 52 ]
    PCGI: Patient-rated Clinical Global Impression

  3. Change from baseline in PSQI [ Time Frame: Baseline to Week 52 ]
    PSQI: Pittsburgh Sleep Quality Index

  4. Change from baseline in SF-36v2 [ Time Frame: Baseline to Week 52 ]
    SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2

  5. Change from baseline in RLS-QOL [ Time Frame: Baseline to Week 52 ]
    RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire

  6. Change from baseline in MOS sleep scale [ Time Frame: Baseline to Week 52 ]
    MOS: Medical outcomes study

  7. Plasma concentration of gabapentin [ Time Frame: Week 12, 28 and 52 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
  • International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study

Exclusion Criteria:

  • Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
  • Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula
  • Pregnant or lactating women
  • Individuals with serum ferritin <20 ng/mL were also excluded from the trial
  • Individuals with movement disorders and/or abnormal neurological findings

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 ClinicalTrials.gov identifier (NCT number): NCT02658188


Locations
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Japan
Chiba, Japan
Fukuoka, Japan
Hokkaido, Japan
Hyogo, Japan
Kanagawa, Japan
Kyoto, Japan
Miyagi, Japan
Osaka, Japan
Saitama, Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02658188    
Other Study ID Numbers: 8825-CL-0005
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Restless legs syndrome patients
ASP8825
XP13512
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents