Restless Legs SyndromeNCT01174459

Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 159 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Restless Legs Syndrome
How many people: 571 participants
Where: 159 sitesJapan
Study dates: Aug 2010to Aug 2013
Phase: Observational
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 500

Who may be able to join

Patient with Restless Legs Syndrome

Who cannot join

None

Trial locations and contacts

159 sites in 1 country.

City, postcode or hospital

159 sites in 1 country

Japan159 sites

Boehringer Ingelheim Investigational Site 119
Akashi
Boehringer Ingelheim Investigational Site 52
Akishima
Boehringer Ingelheim Investigational Site 16
Akita
Boehringer Ingelheim Investigational Site 22
Ami-machi
Boehringer Ingelheim Investigational Site 36
Asahi
Boehringer Ingelheim Investigational Site 1
Asahikawa
Boehringer Ingelheim Investigational Site 40
Chiba
Boehringer Ingelheim Investigational Site 158
Chōfu
Boehringer Ingelheim Investigational Site 78
Chūō
Boehringer Ingelheim Investigational Site 66
Fujisawa
Boehringer Ingelheim Investigational Site 7
Fukagawa
Boehringer Ingelheim Investigational Site 144
Fukuoka
Boehringer Ingelheim Investigational Site 146
Fukuoka
Boehringer Ingelheim Investigational Site 19
Fukushima
Boehringer Ingelheim Investigational Site 132
Fukuyama
Boehringer Ingelheim Investigational Site 82
Gifu
Boehringer Ingelheim Investigational Site 83
Hamamatsu
Boehringer Ingelheim Investigational Site 56
Hatchioji
Boehringer Ingelheim Investigational Site 129
Hayashima-machi
Boehringer Ingelheim Investigational Site 123
Himeji
Boehringer Ingelheim Investigational Site 111
Hirakata
Boehringer Ingelheim Investigational Site 133
Hiroshima
Boehringer Ingelheim Investigational Site 30
Honjō
Boehringer Ingelheim Investigational Site 38
Ichihara
Boehringer Ingelheim Investigational Site 37
Ichikawa
Boehringer Ingelheim Investigational Site 79
Ichikawasango-machi
Boehringer Ingelheim Investigational Site 117
Ikeda
Boehringer Ingelheim Investigational Site 149
Isahaya
Boehringer Ingelheim Investigational Site 118
Itami
Boehringer Ingelheim Investigational Site 10
Iwamizawa
Boehringer Ingelheim Investigational Site 127
Izumo
Boehringer Ingelheim Investigational Site 154
Kagoshima
Boehringer Ingelheim Investigational Site 155
Kagoshima
Boehringer Ingelheim Investigational Site 74
Kanazawa
Boehringer Ingelheim Investigational Site 76
Kanazawa
Boehringer Ingelheim Investigational Site 120
Katō
Boehringer Ingelheim Investigational Site 124
Kawai-machi
Boehringer Ingelheim Investigational Site 60
Kawasaki
Boehringer Ingelheim Investigational Site 63
Kawasaki
Boehringer Ingelheim Investigational Site 31
Keroyama-machi
Boehringer Ingelheim Investigational Site 145
Kitakyuushu
Boehringer Ingelheim Investigational Site 122
Kobe
Boehringer Ingelheim Investigational Site 46
Kodaira
Boehringer Ingelheim Investigational Site 50
Kodaira
Boehringer Ingelheim Investigational Site 32
Koshigaya
Boehringer Ingelheim Investigational Site 101
Kōtari
Boehringer Ingelheim Investigational Site 150
Kumamoto
Boehringer Ingelheim Investigational Site 151
Kumamoto
Boehringer Ingelheim Investigational Site 143
Kurume
Boehringer Ingelheim Investigational Site 102
Kyoto
Boehringer Ingelheim Investigational Site 103
Kyoto
Boehringer Ingelheim Investigational Site 98
Kyoto
Boehringer Ingelheim Investigational Site 99
Kyoto
Boehringer Ingelheim Investigational Site 100
Maizuru
Boehringer Ingelheim Investigational Site 80
Matsumoto
Boehringer Ingelheim Investigational Site 81
Matsumoto
Boehringer Ingelheim Investigational Site 142
Matsuyama
Boehringer Ingelheim Investigational Site 28
Mibu-machi
Boehringer Ingelheim Investigational Site 138
Miki-machi
Boehringer Ingelheim Investigational Site 115
Minoo
Boehringer Ingelheim Investigational Site 47
Mitaka
Boehringer Ingelheim Investigational Site 153
Miyazaki
Boehringer Ingelheim Investigational Site 134
Miyoshi
Boehringer Ingelheim Investigational Site 112
Moriguchi
Boehringer Ingelheim Investigational Site 13
Morioka
Boehringer Ingelheim Investigational Site 2
Muroran
Boehringer Ingelheim Investigational Site 88
Nagakute-machi
Boehringer Ingelheim Investigational Site 41
Nagareyama
Boehringer Ingelheim Investigational Site 148
Nagasaki
Boehringer Ingelheim Investigational Site 85
Nagoya
Boehringer Ingelheim Investigational Site 86
Nagoya
Boehringer Ingelheim Investigational Site 87
Nagoya
Boehringer Ingelheim Investigational Site 92
Nagoya
Boehringer Ingelheim Investigational Site 68
Nigata-honmachi
Boehringer Ingelheim Investigational Site 69
Nigata-honmachi
Boehringer Ingelheim Investigational Site 70
Nigata-honmachi
Boehringer Ingelheim Investigational Site 71
Nigata-honmachi
Boehringer Ingelheim Investigational Site 139
Niihama
Boehringer Ingelheim Investigational Site 141
Niihama
Boehringer Ingelheim Investigational Site 11
Ninohe
Boehringer Ingelheim Investigational Site 121
Nishinomiya
Boehringer Ingelheim Investigational Site 157
Nishitōkyō
Boehringer Ingelheim Investigational Site 17
Ōdate
Boehringer Ingelheim Investigational Site 152
Ōita
Boehringer Ingelheim Investigational Site 130
Okayama
Boehringer Ingelheim Investigational Site 131
Okayama
Boehringer Ingelheim Investigational Site 89
Okazaki
Boehringer Ingelheim Investigational Site 104
Osaka
Boehringer Ingelheim Investigational Site 105
Osaka
Boehringer Ingelheim Investigational Site 106
Osaka
Boehringer Ingelheim Investigational Site 128
Ōta-ku
Boehringer Ingelheim Investigational Site 97
Ōtsu
Boehringer Ingelheim Investigational Site 140
Ōzu
Boehringer Ingelheim Investigational Site 26
Ryūgasaki
Boehringer Ingelheim Investigational Site 147
Saga
Boehringer Ingelheim Investigational Site 64
Sagamihara
Boehringer Ingelheim Investigational Site 34
Saitama
Boehringer Ingelheim Investigational Site 107
Sakai
Boehringer Ingelheim Investigational Site 108
Sakai
Boehringer Ingelheim Investigational Site 39
Sakura
Boehringer Ingelheim Investigational Site 3
Sapporo
Boehringer Ingelheim Investigational Site 4
Sapporo
Boehringer Ingelheim Investigational Site 5
Sapporo
Boehringer Ingelheim Investigational Site 6
Sapporo
Boehringer Ingelheim Investigational Site 8
Sapporo
Boehringer Ingelheim Investigational Site 9
Sapporo
Boehringer Ingelheim Investigational Site 113
Sayama
Boehringer Ingelheim Investigational Site 14
Sendai
Boehringer Ingelheim Investigational Site 15
Sendai
Boehringer Ingelheim Investigational Site 27
Shimotsuke
Boehringer Ingelheim Investigational Site 29
Shimotsuke
Boehringer Ingelheim Investigational Site 125
Shingū
Boehringer Ingelheim Investigational Site 84
Shizuoka
Boehringer Ingelheim Investigational Site 95
Suzuka
Boehringer Ingelheim Investigational Site 96
Suzuka
Boehringer Ingelheim Investigational Site 137
Takamatsu
Boehringer Ingelheim Investigational Site 109
Takatsuki
Boehringer Ingelheim Investigational Site 110
Takatsuki
Boehringer Ingelheim Investigational Site 12
Takizawa-mura
Boehringer Ingelheim Investigational Site 33
Tokorozawa
Boehringer Ingelheim Investigational Site 42
Tokyo Arakawa
Boehringer Ingelheim Investigational Site 53
Tokyo Chuo
Boehringer Ingelheim Investigational Site 43
Tokyo Itabashi
Boehringer Ingelheim Investigational Site 45
Tokyo Meguro
Boehringer Ingelheim Investigational Site 54
Tokyo Minato
Boehringer Ingelheim Investigational Site 49
Tokyo Nerima
Boehringer Ingelheim Investigational Site 55
Tokyo Nerima
Boehringer Ingelheim Investigational Site 44
Tokyo Ota
Boehringer Ingelheim Investigational Site 51
Tokyo Shibuya
Boehringer Ingelheim Investigational Site 58
Tokyo Shibuya
Boehringer Ingelheim Investigational Site 57
Tokyo Shinagawa
Boehringer Ingelheim Investigational Site 48
Tokyo Shinjyuku
Boehringer Ingelheim Investigational Site 21
Toride
Boehringer Ingelheim Investigational Site 126
Tottori
Boehringer Ingelheim Investigational Site 72
Toyama
Boehringer Ingelheim Investigational Site 73
Toyama
Boehringer Ingelheim Investigational Site 90
Toyohashi
Boehringer Ingelheim Investigational Site 93
Toyohashi
Boehringer Ingelheim Investigational Site 91
Toyokawa
Boehringer Ingelheim Investigational Site 94
Toyokawa
Boehringer Ingelheim Investigational Site 114
Toyonaka
Boehringer Ingelheim Investigational Site 116
Toyonaka
Boehringer Ingelheim Investigational Site 20
Tsuchiura
Boehringer Ingelheim Investigational Site 24
Tsukuba
Boehringer Ingelheim Investigational Site 77
Tsuruga
Boehringer Ingelheim Investigational Site 35
Tsurugashima
Boehringer Ingelheim Investigational Site 156
Urazoe
Boehringer Ingelheim Investigational Site 23
Ushiku
Boehringer Ingelheim Investigational Site 25
Ushiku
Boehringer Ingelheim Investigational Site 75
Utinada-machi
Boehringer Ingelheim Investigational Site 18
Yamagata
Boehringer Ingelheim Investigational Site 135
Yanai
Boehringer Ingelheim Investigational Site 59
Yokohama
Boehringer Ingelheim Investigational Site 61
Yokohama
Boehringer Ingelheim Investigational Site 62
Yokohama
Boehringer Ingelheim Investigational Site 65
Yokohama
Boehringer Ingelheim Investigational Site 67
Yokohama
Boehringer Ingelheim Investigational Site 159
Yokose-machi
Boehringer Ingelheim Investigational Site 136
Yoshinogawa

Other trials in Japan

About this study

Conditions: Restless Legs Syndrome
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.

Study groups in NCT01174459
Study group	Role	What they receive
Patient with Restless Legs Syndrome		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Drug-related Adverse Events
Number of patients with drug-related adverse events
Measured: 12 Months

Secondary outcomes (1)

Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.
Measured: after 12 months or at the end of observation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2013

First posted3 Aug 2010 (estimated)
Study startAug 2010
Primary completionAug 2013
Study completionAug 2013

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 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 571 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01174459
Sponsor's protocol ID: 248.678
Status last verified: Aug 2014
First submitted: 2 Aug 2010
Last updated: 29 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
ClinicalTrials.gov ID: NCT01174459
Acronym / sponsor ID: 248.678
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 571 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 3 Aug 2010 (estimated)
Results: Posted 29 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patient with Restless Legs Syndrome	–	–

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 500

Key inclusion criteria (1 listed)

Patient with Restless Legs Syndrome

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of Drug-related Adverse Events
Time frame: 12 Months
Number of patients with drug-related adverse events

1 secondary outcome

Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
Time frame: after 12 months or at the end of observation

Results and safety

Results posted to the registry on 29 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient With Restless Legs Syndrome	571	566

Primary outcome: Incidence of Drug-related Adverse Events

Time frame: 12 Months. Number. Unit: participants

Measure	Patient With Restless Legs Syndrome n = 510
Value	76

Population analysed: Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient With Restless Legs Syndrome	10 of 510 (2%)	0 of 510 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Restless Legs Syndrome

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

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

159 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 159 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 1 inclusion and 1 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 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2014). 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?

Incidence of Drug-related Adverse Events (time frame: 12 Months). 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 NCT01174459.

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 Aug 2014.