Restless Legs SyndromePhase 2NCT00152997
Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
A Phase 2 study testing Pramipexole 0.125 mg tablets in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 7 sites in Japan.
Trial summary
The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International… 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?
- Pramipexole 0.125 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 7 sitesJapan
- Study dates
- Aug 2004to Dec 2005
- 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
- According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following four all criterias must be presented:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in legs
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
- The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night
- PLM (during time in bed) index of at least 5 per hour (in the worst affected leg) at Visit 3
- Total score of RLS severity scale-Japanese version by IRLSSG > 15 at Visit 3
- At least 1 time per week of RLS symptoms interfering with sleep within the last one month at Visit 1.
Who cannot join
- Pre-menopausal women who meet any one of the following (1) - (3):
- Pregnant or possibly pregnant
- In lactation
- Desire to be pregnant during study period Even when a patient was confirmed not to fall under the criteria above at initiation of study, if the patient is of childbearing potential, pregnancy tests should be performed when possible. If pregnancy test is positive, the investigational product should be discontinued.
- Males not using an adequate form of contraception.
- Patients who took the neuroleptics within 4 weeks before the screening Visit 1, or neuroleptic-induced akathisia.
Show all 12Show fewer
- Patients who can not stop the treatment with medication or dietary supplements, which could significantly influence RLS symptoms to wash-out at least 14 days before drug administration (refer to Appendix 3 for prohibited medication), e.g. dopaminergic drugs (levodopa or dopamine agonists) or antidopaminergic drugs (neuroleptics or metoclopramide etc.), MAO inhibitors, sympathomimetics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, folic acid, vitamin B12, antihistaminics, lithium, melatonin.
- Patients with diabetes mellitus requiring insulin therapy.
- Patients with microcytic anemia at investigators discretion.
- History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms.
- Other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnea syndrome (with AHI >15 at Visit 3, or a history of loud snoring occurring at least 5 nights a week combined with a history of breathing pauses during sleep and excessive daytime sleepiness).
- Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Boehringer Ingelheim Investigational Site
Akita, Akita
Boehringer Ingelheim Investigational Site
Kochi, Kochi
Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
Boehringer Ingelheim Investigational Site
Otaru,Hokkaido
Boehringer Ingelheim Investigational Site
Sakai, Osaka
Boehringer Ingelheim Investigational Site
Shibuya,Tokyo
Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.
The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.
- Conditions
- Restless Legs Syndrome
- Being tested
- Pramipexole 0.125 mg tablets, Pramipexole 0.125 mg tablets Placebo
- 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.
Pramipexole 0.125 mg tabletsDrug
Pramipexole 0.125 mg tablets PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG
Secondary outcomes (1)
Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2005
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152997
- Sponsor's protocol ID
- 248.557
- Status last verified
- Oct 2013
- First submitted
- 9 Sep 2005
- Last updated
- 31 Oct 2013
- Results posted
- No
Publications
Inoue Y, Oka Y, Kagimura T, Kuroda K, Hirata K. Reliability, validity, and responsiveness of the Japanese version of International Restless Legs Syndrome Study Group rating scale for restless legs syndrome in a clinical trial setting. Psychiatry Clin Neurosci. 2013 Sep;67(6):412-9. doi: 10.1111/pcn.12074. Epub 2013 Aug 5.
PubMed 23910574
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.
- ClinicalTrials.gov ID
- NCT00152997
- Acronym / sponsor ID
- 248.557
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2005 (actual)
- First posted
- 12 Sep 2005 (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 trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following four all criterias must be presented:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in legs
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
- The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
- The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night
Key exclusion criteria (12 listed)
- Pre-menopausal women who meet any one of the following (1) - (3):
- Males not using an adequate form of contraception.
- Patients who took the neuroleptics within 4 weeks before the screening Visit 1, or neuroleptic-induced akathisia.
- Patients who can not stop the treatment with medication or dietary supplements, which could significantly influence RLS symptoms to wash-out at least 14 days before drug administration (refer to Appendix 3 for prohibited medication), e.g. dopaminergic drugs (levodopa or dopamine agonists) or antidopaminergic drugs (neuroleptics or metoclopramide etc.), MAO inhibitors, sympathomimetics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, folic acid, vitamin B12, antihistaminics, lithium, melatonin.
- Patients with diabetes mellitus requiring insulin therapy.
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 |
|---|---|---|
| Pramipexole 0.125 mg tablets | Drug | – |
| Pramipexole 0.125 mg tablets Placebo | Drug | – |
Primary outcome
Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG
1 secondary outcome
Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG )
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 31 Oct 2013.
- Derived from this study: PubMed 23910574Inoue Y, Oka Y, Kagimura T, Kuroda K, Hirata K. Reliability, validity, and responsiveness of the Japanese version of International Restless Legs Syndrome Study Group rating scale for restless legs syndrome in a clinical trial setting. Psychiatry Clin Neurosci. 2013 Sep;67(6):412-9. doi: 10.1111/pcn.12074. Epub 2013 Aug 5.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
7 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 Pramipexole 0.125 mg tablets in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 7 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 8 inclusion and 12 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG. 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 NCT00152997, 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 31 Oct 2013.