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Completed

NCT Number: NCT02658188

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

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP8825

Drug

Oral

Other names: gabapentin enacarbil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2016
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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