Idiopathic Restless Legs SyndromePhase 3NCT00390689
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
A Phase 3 study testing Pramipexole 0.125 mg tablet and Pramipexole 0.5 mg tablet in people with Idiopathic Restless Legs Syndrome, run by Boehringer Ingelheim at 34 sites in Japan.
Trial summary
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Idiopathic Restless Legs Syndrome
- What is being tested?
- Pramipexole 0.125 mg tablet and Pramipexole 0.5 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 34 sitesJapan
- Study dates
- Oct 2006to Mar 2008
- Phase
- Phase 3
- 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
- Male or female patients between 20 and 80 years
- Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (IRLSSG):
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the 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.
- Patients with a total score larger than 15 on the IRLS at Visit 2
Who cannot join
- Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period
- Patients who cannot take adequate contraceptive measures
- Patients with a history of akathisia induced by neuroleptics
- Patients with diabetes mellitus requiring insulin therapy
- Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
- Patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, Parkinson's disease or other neurological diseases that may result in the occurrence of secondary RLS in the physical function tests or neurological tests
- Patients with other sleep disorders such as abnormal behaviour during Rapid eye movement (REM) sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
248.627.037 Boehringer Ingelheim Investigational Site
Aichi-gun, Aichi
248.627.014 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
248.627.029 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
248.627.032 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
248.627.030 Boehringer Ingelheim Investigational Site
Kagoshima, Kagoshima
248.627.013 Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama
248.627.033 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa
248.627.027 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
248.627.023 Boehringer Ingelheim Investigational Site
Kitakyusyu, Fukuoka
248.627.024 Boehringer Ingelheim Investigational Site
Kitakyusyu, Fukuoka
248.627.022 Boehringer Ingelheim Investigational Site
Kochi, Kochi
248.627.034 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
248.627.038 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
248.627.041 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
248.627.039 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto
248.627.003 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
248.627.036 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
248.627.025 Boehringer Ingelheim Investigational Site
Mitaka-shi, Tokyo
248.627.015 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
248.627.017 Boehringer Ingelheim Investigational Site
Osaka, Osaka
248.627.011 Boehringer Ingelheim Investigational Site
Otaru, Hokkaido
248.627.026 Boehringer Ingelheim Investigational Site
Otsu, Shiga
248.627.002 Boehringer Ingelheim Investigational Site
Sakai,Osaka
248.627.010 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
248.627.035 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
248.627.012 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
248.627.001 Boehringer Ingelheim Investigational Site
Shibuya-ku, Tokyo
248.627.004 Boehringer Ingelheim Investigational Site
Shimotsuga-gun,Tochigi
248.627.040 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
248.627.018 Boehringer Ingelheim Investigational Site
Takatsuki,Osaka
248.627.028 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
248.627.019 Boehringer Ingelheim Investigational Site
Tokushima, Tokushima
248.627.016 Boehringer Ingelheim Investigational Site
Toyohashi, Aichi
248.627.031 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
About this study
Official title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.
- Conditions
- Idiopathic Restless Legs Syndrome
- Being tested
- Pramipexole 0.125 mg tablet, Pramipexole 0.5 mg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole 0.125 mg tabletDrug
Pramipexole 0.5 mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole 0.25 mg once daily | Experimental | Pramipexole 0.25 mg given once daily Receives: Drug: Pramipexole 0.125 mg tablet |
| Pramipexole 0.5 mg once daily | Experimental | Pramipexole 0.5 mg given once daily Receives: Drug: Pramipexole 0.5 mg tablet |
| Pramipexole 0.75 mg once daily | Experimental | Pramipexole 0.75 mg given once daily Receives: Drug: Pramipexole 0.125 mg tablet; Drug: Pramipexole 0.5 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.
Measured: Week 6 - change from baseline
Secondary outcomes (13)
IRLS Responder
The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)
Measured: baseline to week 6
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).
Measured: Week 6 - change from baseline
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)
Measured: Week 6 - change from baseline
Clinical Global Impression Global Improvement (CGI-I) Responder
CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.
Measured: baseline to week 6
Patient Global Impression (PGI) Responder
PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.
Measured: baseline to week 6
Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
Measured: baseline to 6 weeks
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).
Measured: Week 52 - change from baseline
IRLS Responder for Open-label Period
The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)
Measured: baseline to week 52
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).
Measured: Week 52 - change from baseline
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)
Measured: Week 52 - change from baseline
Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.
Measured: baseline to week 52
Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.
Measured: baseline to week 52
Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week
Measured: baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390689
- Sponsor's protocol ID
- 248.627
- Status last verified
- Apr 2014
- First submitted
- 19 Oct 2006
- Last updated
- 2 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study
- ClinicalTrials.gov ID
- NCT00390689
- Acronym / sponsor ID
- 248.627
- Conditions
- Idiopathic Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- First posted
- 20 Oct 2006 (estimated)
- Results
- Posted 25 Aug 2009
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 double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pramipexole 0.25 mg once daily | Experimental | Drug: Pramipexole 0.125 mg tabletPramipexole 0.25 mg given once daily |
| Pramipexole 0.5 mg once daily | Experimental | Drug: Pramipexole 0.5 mg tabletPramipexole 0.5 mg given once daily |
| Pramipexole 0.75 mg once daily | Experimental | Drug: Pramipexole 0.125 mg tablet, Drug: Pramipexole 0.5 mg tabletPramipexole 0.75 mg given once daily |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients between 20 and 80 years
- Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (IRLSSG):
- Patients with a total score larger than 15 on the IRLS at Visit 2
Key exclusion criteria (7 listed)
- Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period
- Patients who cannot take adequate contraceptive measures
- Patients with a history of akathisia induced by neuroleptics
- Patients with diabetes mellitus requiring insulin therapy
- Patients who are judged to have microcytic anaemia by the 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 |
|---|---|---|
| Pramipexole 0.125 mg tablet | Drug | Pramipexole 0.25 mg once daily, Pramipexole 0.75 mg once daily |
| Pramipexole 0.5 mg tablet | Drug | Pramipexole 0.5 mg once daily, Pramipexole 0.75 mg once daily |
Primary outcome
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks
Time frame: Week 6 - change from baseline
The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.
13 secondary outcomes
IRLS Responder
Time frame: baseline to week 6
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks
Time frame: Week 6 - change from baseline
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks
Time frame: Week 6 - change from baseline
Clinical Global Impression Global Improvement (CGI-I) Responder
Time frame: baseline to week 6
Patient Global Impression (PGI) Responder
Time frame: baseline to week 6
Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.
Time frame: baseline to 6 weeks
Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period
Time frame: Week 52 - change from baseline
IRLS Responder for Open-label Period
Time frame: baseline to week 52
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period
Time frame: Week 52 - change from baseline
Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period
Time frame: Week 52 - change from baseline
Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period
Time frame: baseline to week 52
Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period
Time frame: baseline to week 52
Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period
Time frame: baseline to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- 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 chair
Boehringer Ingelheim
34 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 Pramipexole 0.125 mg tablet and Pramipexole 0.5 mg tablet in people with Idiopathic Restless Legs Syndrome, run by Boehringer Ingelheim at 34 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 7 inclusion and 7 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
Yes. Results are posted in the registry (first posted 25 Aug 2009). 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 (IRLS) Total Score at 6 Weeks (time frame: Week 6 - change from baseline). 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 2 Jul 2014.