Restless Legs SyndromePhase 3NCT02658188
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
A Phase 3 study testing ASP8825 in people with Restless Legs Syndrome, run by Astellas Pharma Inc at 10 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- ASP8825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 10 sitesJapan
- Study dates
- Dec 2007to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Chiba
Study site
Fukuoka
Study site
Hokkaido
Study site
Hyōgo
Study site
Kanagawa
Study site
Kyoto
Study site
Miyagi
Study site
Osaka
Study site
Saitama
Study site
Tokyo
About this study
Official title: Long-term Study - 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- ASP8825
- Keywords
- Restless legs syndrome patients, ASP8825, XP13512
- 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.
ASP8825Drug
Also called gabapentin enacarbil
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP8825 group | Experimental | Not described Receives: Drug: ASP8825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in IRLS score
IRLS: International Restless Legs Syndrome Scale
Measured: Baseline to Week 52
Safety assessed by Vital signs
Blood pressure and pulse rate
Measured: Up to Week 52
Safety assessed by Adverse Events
Measured: Up to Week 52
Safety assessed by Laboratory tests
Hematology, blood biochemistry, thyroid function test and urinalysis
Measured: Up to Week 52
Safety assessed by 12-lead-electrocardiogram
Measured: Up to Week 52
Secondary outcomes (7)
Proportion of responders on ICGl of improvement
ICGI: Investigator-rated Clinical Global Impression of improvement
Measured: Up to Week 52
Proportion of responders on PCGI of improvement
PCGI: Patient-rated Clinical Global Impression
Measured: Up to Week 52
Change from baseline in PSQI
PSQI: Pittsburgh Sleep Quality Index
Measured: Baseline to Week 52
Change from baseline in SF-36v2
SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2
Measured: Baseline to Week 52
Change from baseline in RLS-QOL
RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire
Measured: Baseline to Week 52
Change from baseline in MOS sleep scale
MOS: Medical outcomes study
Measured: Baseline to Week 52
Plasma concentration of gabapentin
Measured: Week 12, 28 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658188
- Sponsor's protocol ID
- 8825-CL-0005
- Status last verified
- Feb 2016
- First submitted
- 13 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
- ClinicalTrials.gov ID
- NCT02658188
- Acronym / sponsor ID
- 8825-CL-0005
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless legs syndrome patients, ASP8825, XP13512
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP8825 group | Experimental | Drug: ASP8825 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8825Also: gabapentin enacarbilOral | Drug | ASP8825 group |
Primary outcome
Change from baseline in IRLS score
Time frame: Baseline to Week 52
IRLS: International Restless Legs Syndrome Scale
Safety assessed by Vital signs
Time frame: Up to Week 52
Blood pressure and pulse rate
Safety assessed by Adverse Events
Time frame: Up to Week 52
Safety assessed by Laboratory tests
Time frame: Up to Week 52
Hematology, blood biochemistry, thyroid function test and urinalysis
Safety assessed by 12-lead-electrocardiogram
Time frame: Up to Week 52
7 secondary outcomes
Proportion of responders on ICGl of improvement
Time frame: Up to Week 52
Proportion of responders on PCGI of improvement
Time frame: Up to Week 52
Change from baseline in PSQI
Time frame: Baseline to Week 52
Change from baseline in SF-36v2
Time frame: Baseline to Week 52
Change from baseline in RLS-QOL
Time frame: Baseline to Week 52
Change from baseline in MOS sleep scale
Time frame: Baseline to Week 52
Plasma concentration of gabapentin
Time frame: Week 12, 28 and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASP8825 in people with Restless Legs Syndrome, run by Astellas Pharma Inc at 10 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 2 inclusion and 5 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 IRLS score (time frame: Baseline to Week 52). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2016.