Restless Legs Syndrome (RLS)Phase 4NCT01981941
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
A Phase 4 study testing Gabapentin enacarbil in people with Restless Legs Syndrome (RLS), run by Astellas Pharma Inc at 5 sites in Japan.
Trial summary
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. 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?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesJapan
- Study dates
- 5 Nov 2013to 13 May 2015
- Phase
- Phase 4
- 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 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chūbu
Study site
Chugoku
Study site
Kansai
Study site
Kanto
Study site
Kyushu
About this study
Official title: Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-
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.
Read the 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.
- Conditions
- Restless Legs Syndrome (RLS)
- Being tested
- Gabapentin enacarbil
- Keywords
- Gabapentin, Restless legs syndrome (RLS)
- 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.
Gabapentin enacarbilDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Oral Receives: Drug: Gabapentin enacarbil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Leg Syndrome (IRLS) rating scale score
Measured: Baseline and at 4 week of the treatment (or at discontinuation)
Secondary outcomes (4)
Change in Investigator-rated clinical global impression (ICGI) score
Measured: Baseline and at 4 week of the treatment (or at discontinuation)
Change in Patient-related clinical global impression (PCGI) score
Baseline and at 4 week of the treatment (or at discontinuation)
Measured: 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
Measured: Up to 5 weeks
Plasma gabapentin concentration
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start5 Nov 2013
- Primary completion13 May 2015
- Study completion13 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs Syndrome (RLS)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Principal investigator, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981941
- Sponsor's protocol ID
- 8825-CL-0103
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2013
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment-
- ClinicalTrials.gov ID
- NCT01981941
- Acronym / sponsor ID
- 8825-CL-0103
- Conditions
- Restless Legs Syndrome (RLS)
- Keywords
- Gabapentin, Restless legs syndrome (RLS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 13 May 2015 (actual)
- Study completion
- 13 May 2015 (actual)
- First posted
- 13 Nov 2013 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Gabapentin enacarbilOral |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Gabapentin enacarbilOral | Drug | Treatment group |
Primary outcome
Change in International Restless Leg Syndrome (IRLS) rating scale score
Time frame: Baseline and at 4 week of the treatment (or at discontinuation)
4 secondary outcomes
Change in Investigator-rated clinical global impression (ICGI) score
Time frame: Baseline and at 4 week of the treatment (or at discontinuation)
Change in Patient-related clinical global impression (PCGI) score
Time frame: 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
Plasma gabapentin concentration
Time frame: Up to 5 weeks
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 8 Nov 2024.
- Individual participant dataSharing planned: 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/.
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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 principal investigator
Astellas Pharma Inc
5 sites in 1 country: see every site and its status.
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 5 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 4 inclusion and 11 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
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 in International Restless Leg Syndrome (IRLS) rating scale score (time frame: Baseline and at 4 week of the treatment (or at discontinuation)). 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 8 Nov 2024.