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Restless Legs Syndrome (RLS)Phase 4NCT03053427

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

A Phase 4 study testing Gabapentin enacarbil in people with Restless Legs Syndrome (RLS), run by Astellas Pharma Inc at 46 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Restless Legs Syndrome (RLS)
What is being tested?
Gabapentin enacarbil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
46 sitesJapan
Study dates
30 Mar 2017to 25 Jun 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has Restless Legs Syndrome (RLS), based on the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria.
  • Subject has reported history of RLS symptoms for at least 15 days in the month prior to the first dosing; if on treatment, this frequency of symptoms was started before treatment.
  • Subject with International Restless Legs Syndrome Rating Scale (IRLS) score ≥ 15.
  • Subject has discontinued dopamine agonists, and/or gabapentin at least 1 week prior to the first dosing.
  • Subject has discontinued other treatments for RLS at least 2 weeks prior to the first dosing.
  • Female subject must either:
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  • Be of non-childbearing potential:
  • Post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
  • documented surgically sterile
  • Or, if of childbearing potential:
  • Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
  • And have a negative urine pregnancy test at Screening
  • And, if heterosexually active, agree to consistently use two forms of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
  • Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study while on treatment.
  • Subject with a Body Mass Index of ≥ 18.5 and < 30.
  • Subject with estimated creatinine clearance of ≥ 60 mL/min.

Who cannot join

  • Subject has a sleep disorder that may significantly affect the assessment of RLS.
  • Subject has a history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment.
  • Subject has neurologic disease or movement disorder.
  • Subject has poorly controlled diabetes, iron deficiency anemia, or are currently taking any sedative/hypnotic.
  • Subject has a history of suicide attempt within 6 months prior to informed consent.
  • Subject has a high level of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST).
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  • Subject is currently suffering from moderate or severe depression.
  • Subject has a history of alcohol dependence or drug abuse, or subject had alcohol or drug abuse or dependence in the last 1 year.
  • Subject is a shift worker, professional driver, or operator of dangerous machinery.
  • Subject has clinically significant or unstable medical conditions.
  • Subject has a history of hypersensitivity reaction to gabapentin.
  • Subject has previously taken pregabalin, gabapentin enacarbil, or the study drug of Gabapentin enacarbil.
  • Subject has participated in a clinical study for another investigational drug or medical device or post-marketing clinical study within 12 weeks (84 days) prior to the first dosing, or is currently participating in any of these studies.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Japan46 sites

  • Site JP00012

    Arakawa City, Tokyo

  • Site JP00031

    Chiba

  • Site JP00001

    Chōfu, Tokyo

  • Site JP00028

    Chōfu, Tokyo

  • Site JP00018

    Chūō, Tokyo

  • Site JP00024

    Chūō, Tokyo

  • Site JP00036

    Fukuoka

  • Site JP00041

    Kawanishi, Hyōgo

  • Site JP00038

    Kawasaki, Kanagawa

  • Site JP00006

    Kitakyushu, Fukuoka

  • Site JP00022

    Kitakyushu, Fukuoka

  • Site JP00005

    Kobe, Hyōgo

  • Site JP00020

    Kyoto

  • Site JP00035

    Kyoto

  • Site JP00048

    Meguro City, Tokyo

  • Site JP00034

    Musashino, Tokyo

  • Site JP00025

    Nagoya, Aichi-ken

  • Site JP00029

    Nagoya, Aichi-ken

  • Site JP00040

    Nagoya, Aichi-ken

  • Site JP00046

    Nakano City, Tokyo

  • Site JP00010

    Osaka

  • Site JP00026

    Osaka

  • Site JP00037

    Osaka

  • Site JP00039

    Osaka

  • Site JP00047

    Osaka

  • Site JP00019

    Ōta-ku, Tokyo

  • Site JP00030

    Saitama

  • Site JP00044

    Saitama

  • Site JP00032

    Sakai, Osaka

  • Site JP00002

    Sapporo, Hokkaido

  • Site JP00003

    Sapporo, Hokkaido

  • Site JP00004

    Sapporo, Hokkaido

  • Site JP00023

    Sapporo, Hokkaido

  • Site JP00011

    Shibuya City, Tokyo

  • Site JP00013

    Shinagawa, Tokyo

  • Site JP00015

    Shinagawa, Tokyo

  • Site JP00016

    Shinagawa, Tokyo

  • Site JP00008

    Shinjuku, Tokyo

  • Site JP00014

    Shinjuku, Tokyo

  • Site JP00021

    Shinjuku, Tokyo

  • Site JP00043

    Tokorozawa, Saitama

  • Site JP00007

    Yokohama, Kanagawa

  • Site JP00017

    Yokohama, Kanagawa

  • Site JP00049

    Yokohama, Kanagawa

  • Site JP00050

    Yokohama, Kanagawa

  • Site JP00009

    Yokosuka, Kanagawa

Other trials in Japan

About this study

Official title: Gabapentin Enacarbil Post-marketing Clinical Study A Randomized, Double-blind, Placebo-controlled, Parallel-group Study in Subjects With Restless Legs Syndrome.

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

Read the detailed description

After 1 week run in period with single-blind placebo, participants meeting the inclusion and none of the exclusion criteria were randomized to receive double-blind treatment with either gabapentin enacarbil 600 mg or placebo for 12 weeks treatment period. After then, single-blind placebo was given for 1 week for follow-up observation.

Being tested
Placebo, Gabapentin enacarbil
Keywords
Restless Legs Syndrome, ASP8825, Gabapentin enacarbil
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Oral administration

  • Gabapentin enacarbilDrug

    Also called Regnite

    Oral administration

Study groups in NCT03053427
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo was administered orally once daily after the evening meal.
Receives: Drug: Placebo
Gabapentin enacarbilExperimentalGabapentin enacarbil was administered orally once daily after the evening meal. Participants with an estimated creatinine clearance of ≥ 60 mL/min to < 90 mL/min at the start of the run-in period were administrated gabapentin enacarbil 300 mg for 1 week followed by gabapentin enacarbil 600 mg for 11 weeks.
Receives: Drug: Gabapentin enacarbil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12

    The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.

    Measured: Baseline and week 12

Secondary outcomes (8)

  1. Change From Baseline in IRLS Score at Each Time Point

    ANCOVA model with the baseline value as a covariate was used.

    Measured: Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)

  2. Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response

    ICGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.

    Measured: EoT (week 12)

  3. Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response

    PCGI was assessed by 7-point ordinate scale. Participants who were "Very much improved" or "Much improved" were defined as responders.

    Measured: EoT (week 12)

  4. Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)

    The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used.

    Measured: Baseline and EoT (week 12)

  5. Change From Baseline in Athens Insomnia Scale

    Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used.

    Measured: Baseline and EoT (week 12)

  6. Change From Baseline in Restless Legs Syndrome (RLS) Pain Score

    The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used.

    Measured: Baseline and EoT (week 12)

  7. Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)

    Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status).

    Measured: Baseline and EoT (week 12)

  8. Number of Participants With Adverse Events

    Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.

    Measured: From first dose of study drug up to week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2017
  2. Study start30 Mar 2017
  3. Primary completion25 Jun 2018
  4. Study completion25 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053427
Sponsor's protocol ID
8825-CL-0101
Status last verified
Nov 2024
First submitted
12 Feb 2017
Last updated
12 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gabapentin enacarbil in people with Restless Legs Syndrome (RLS), run by Astellas Pharma Inc at 46 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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