Restless Legs SyndromePhase 2NCT00530530
ASP8825 - Study in Patients With Restless Legs Syndrome
A Phase 2 study testing ASP8825 in people with Restless Legs Syndrome, run by Astellas Pharma Inc at 6 sites in Japan.
Trial summary
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with 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
- What is being tested?
- ASP8825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- 6 sitesJapan
- Study dates
- Sep 2007to Jan 2009
- Phase
- Phase 2
- 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 with RLS, based on the International RSL Study Group Diagnostic Criteria
- History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
- Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period
Who cannot join
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
- A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyusyu
Study site
Tōhoku
About this study
Official title: ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
Read the detailed description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
- Conditions
- Restless Legs Syndrome
- Being tested
- ASP8825, Placebo
- Keywords
- ASP8825, Restless legs Syndrome, 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 XP13512
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose 1 Receives: Drug: ASP8825 |
| 2 | Experimental | Dose 2 Receives: Drug: ASP8825 |
| 3 | Experimental | Dose 3 Receives: Drug: ASP8825 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the International Restless Legs Syndrome rating scale score
Measured: 12 weeks
Secondary outcomes (6)
Investigator-related Clinical Global Impression of Improvement
Measured: 12 weeks
Patient- related Clinical Global Impression of Improvement
Measured: 12 weeks
The Pittsburgh sleep quality index
Measured: 12 weeks
The SF-36 Health Survey
Measured: 12 weeks
The Restless Legs Syndrome QOL Questionnaire
Measured: 12 weeks
The Medical Outcomes Study sleep scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530530
- Sponsor's protocol ID
- 8825-CL-0003
- Status last verified
- Oct 2014
- First submitted
- 13 Sep 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30.
PubMed 23121149
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00530530
- Acronym / sponsor ID
- 8825-CL-0003
- Conditions
- Restless Legs Syndrome
- Keywords
- ASP8825, Restless legs Syndrome, XP13512
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Sep 2007 (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 demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
Detailed description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ASP8825Dose 1 |
| 2 | Experimental | Drug: ASP8825Dose 2 |
| 3 | Experimental | Drug: ASP8825Dose 3 |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
- History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
- Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period
Key exclusion criteria (3 listed)
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
- A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
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: XP13512oral | Drug | 1, 2, 3 |
| Placebooral | Drug | 4 |
Primary outcome
The change of the International Restless Legs Syndrome rating scale score
Time frame: 12 weeks
6 secondary outcomes
Investigator-related Clinical Global Impression of Improvement
Time frame: 12 weeks
Patient- related Clinical Global Impression of Improvement
Time frame: 12 weeks
The Pittsburgh sleep quality index
Time frame: 12 weeks
The SF-36 Health Survey
Time frame: 12 weeks
The Restless Legs Syndrome QOL Questionnaire
Time frame: 12 weeks
The Medical Outcomes Study sleep scale
Time frame: 12 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 29 Oct 2014.
- Derived from this study: PubMed 23121149Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30.
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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.
Central Contact study chair
Astellas Pharma Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP8825 in people with Restless Legs Syndrome, run by Astellas Pharma Inc at 6 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 3 inclusion and 3 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change of the International Restless Legs Syndrome rating scale score (time frame: 12 weeks). 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 NCT00530530, which also lists 1 linked publication.
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 29 Oct 2014.