Restless Legs SyndromeNCT00721279

Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 127 sites in Austria.

Completed

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

Trial summary

The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
What is being tested?: Sifrol® (pramipexole dihydrochloride)
How many people: 549 participants
Where: 127 sitesAustria
Study dates: Sep 2007to Oct 2008
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with idiopathic RLS

Who may be able to join

Primary Restless Legs Syndrome (i.e. idiopathic RLS)
Indication for treatment with pramipexole
Male or female patients older than 18 years

Who cannot join

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
Current treatment with pramipexole

Trial locations and contacts

127 sites in 1 country.

City, postcode or hospital

127 sites in 1 country

Austria127 sites

Boehringer Ingelheim Investigational Site
Absam
Boehringer Ingelheim Investigational Site
Absdorf
Boehringer Ingelheim Investigational Site
Afritz
Boehringer Ingelheim Investigational Site
Alkoven
Boehringer Ingelheim Investigational Site
Altenmarkt/Zauchensee
Boehringer Ingelheim Investigational Site
Anif
Boehringer Ingelheim Investigational Site
Au
Boehringer Ingelheim Investigational Site
Bad Goisern am Hallstättersee
Boehringer Ingelheim Investigational Site
Bad Schallerbach
Boehringer Ingelheim Investigational Site
Bad Vöslau
Boehringer Ingelheim Investigational Site
Baden
Boehringer Ingelheim Investigational Site
Bärnbach
Boehringer Ingelheim Investigational Site
Bleiburg
Boehringer Ingelheim Investigational Site
Bludenz
Boehringer Ingelheim Investigational Site
Bregenz
Boehringer Ingelheim Investigational Site
Bruck A.d. Mur
Boehringer Ingelheim Investigational Site
Deutschkreutz
Boehringer Ingelheim Investigational Site
Deutschlandsberg
Boehringer Ingelheim Investigational Site
Dornbirn
Boehringer Ingelheim Investigational Site
Ebensee
Boehringer Ingelheim Investigational Site
Faak am See
Boehringer Ingelheim Investigational Site
Ferlach
Boehringer Ingelheim Investigational Site
Fieberbrunn
Boehringer Ingelheim Investigational Site
Filzmoos
Boehringer Ingelheim Investigational Site
Fischamend
Boehringer Ingelheim Investigational Site
Fohnsdorf
Boehringer Ingelheim Investigational Site
Fritzens
Boehringer Ingelheim Investigational Site
Gallizien
Boehringer Ingelheim Investigational Site
Gallspach
Boehringer Ingelheim Investigational Site
Gaspoldshofen
Boehringer Ingelheim Investigational Site
Gerasdorf bei Wien
Boehringer Ingelheim Investigational Site
Gloggnitz
Boehringer Ingelheim Investigational Site
Gmunden
Boehringer Ingelheim Investigational Site
Grafenstein
Boehringer Ingelheim Investigational Site
Graz
Boehringer Ingelheim Investigational Site
Großklein
Boehringer Ingelheim Investigational Site
Grünbach
Boehringer Ingelheim Investigational Site
Haid
Boehringer Ingelheim Investigational Site
Halbturn
Boehringer Ingelheim Investigational Site
Hall in Tirol
Boehringer Ingelheim Investigational Site
Hart
Boehringer Ingelheim Investigational Site
Heidenreichstein
Boehringer Ingelheim Investigational Site
Hornstein
Boehringer Ingelheim Investigational Site
Innsbruck
Boehringer Ingelheim Investigational Site
Jenbach
Boehringer Ingelheim Investigational Site
Judenburg
Boehringer Ingelheim Investigational Site
Kapfenberg
Boehringer Ingelheim Investigational Site
Kematen
Boehringer Ingelheim Investigational Site
Klagenfurt
Boehringer Ingelheim Investigational Site
Kleinzell
Boehringer Ingelheim Investigational Site
Klosterneuburg
Boehringer Ingelheim Investigational Site
Krems
Boehringer Ingelheim Investigational Site
Kufstein
Boehringer Ingelheim Investigational Site
Laakirchen
Boehringer Ingelheim Investigational Site
Längenfeld
Boehringer Ingelheim Investigational Site
Langenwang
Boehringer Ingelheim Investigational Site
Lavamünd
Boehringer Ingelheim Investigational Site
Leibnitz, Styria
Boehringer Ingelheim Investigational Site
Leoben
Boehringer Ingelheim Investigational Site
Leopoldsdorf
Boehringer Ingelheim Investigational Site
Linz
Boehringer Ingelheim Investigational Site
Litschau
Boehringer Ingelheim Investigational Site
Litzelsdorf
Boehringer Ingelheim Investigational Site
Lofer
Boehringer Ingelheim Investigational Site
Marbach
Boehringer Ingelheim Investigational Site
Mattersburg
Boehringer Ingelheim Investigational Site
Meiningen
Boehringer Ingelheim Investigational Site
Melk
Boehringer Ingelheim Investigational Site
Micheldorf
Boehringer Ingelheim Investigational Site
Michelhausen
Boehringer Ingelheim Investigational Site
Mödling
Boehringer Ingelheim Investigational Site
Münzbach
Boehringer Ingelheim Investigational Site
Neufelden
Boehringer Ingelheim Investigational Site
Neunkirchen
Boehringer Ingelheim Investigational Site
Ottenheim
Boehringer Ingelheim Investigational Site
Pabneukirchen
Boehringer Ingelheim Investigational Site
Parndorf
Boehringer Ingelheim Investigational Site
Passail
Boehringer Ingelheim Investigational Site
Pernegg
Boehringer Ingelheim Investigational Site
Pinggau
Boehringer Ingelheim Investigational Site
Pischelsdorf
Boehringer Ingelheim Investigational Site
Poysdorf
Boehringer Ingelheim Investigational Site
Reichental
Boehringer Ingelheim Investigational Site
Ried im Innkreis
Boehringer Ingelheim Investigational Site
Roppen
Boehringer Ingelheim Investigational Site
Rüstorf
Boehringer Ingelheim Investigational Site
Saint Andrä
Boehringer Ingelheim Investigational Site
Saint Peter
Boehringer Ingelheim Investigational Site
Salzburg
Boehringer Ingelheim Investigational Site
Sandl
Boehringer Ingelheim Investigational Site
Sankt Florian
Boehringer Ingelheim Investigational Site
Sankt Gertraud
Boehringer Ingelheim Investigational Site
Sankt Pölten
Boehringer Ingelheim Investigational Site
Sankt Valentin
Boehringer Ingelheim Investigational Site
Sankt Veit an der Glan
Boehringer Ingelheim Investigational Site
Satteins
Boehringer Ingelheim Investigational Site
Schattendorf
Boehringer Ingelheim Investigational Site
Schörfling
Boehringer Ingelheim Investigational Site
Schwaz
Boehringer Ingelheim Investigational Site
Schwechat
Boehringer Ingelheim Investigational Site
Soielberg
Boehringer Ingelheim Investigational Site
Spielberg
Boehringer Ingelheim Investigational Site
Steinbrunn
Boehringer Ingelheim Investigational Site
Stockerau
Boehringer Ingelheim Investigational Site
Strallegg
Boehringer Ingelheim Investigational Site
Telfs
Boehringer Ingelheim Investigational Site
Veitsch
Boehringer Ingelheim Investigational Site
Vienna
Boehringer Ingelheim Investigational Site
Villach
Boehringer Ingelheim Investigational Site
Völs
Boehringer Ingelheim Investigational Site
Vorchdorf
Boehringer Ingelheim Investigational Site
Wagna
Boehringer Ingelheim Investigational Site
Walding
Boehringer Ingelheim Investigational Site
Wals
Boehringer Ingelheim Investigational Site
Wartberg
Boehringer Ingelheim Investigational Site
Wattens
Boehringer Ingelheim Investigational Site
Weer
Boehringer Ingelheim Investigational Site
Weißkirchen in Steiermark
Boehringer Ingelheim Investigational Site
Weiz
Boehringer Ingelheim Investigational Site
Wels
Boehringer Ingelheim Investigational Site
Wiener Neudorf
Boehringer Ingelheim Investigational Site
Wiener Neustadt
Boehringer Ingelheim Investigational Site
Wieselburg
Boehringer Ingelheim Investigational Site
Wilhelmsburg
Boehringer Ingelheim Investigational Site
Windhaag
Boehringer Ingelheim Investigational Site
Wolkersdorf
Boehringer Ingelheim Investigational Site
Zirl

Other trials in Austria

About this study

Official title: Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS

Conditions: Restless Legs Syndrome
Being tested: Sifrol® (pramipexole dihydrochloride)
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.

Sifrol® (pramipexole dihydrochloride)Drug

What is being measured

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

Frequency Analysis for Baseline Pattern of RLS Symptoms
Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
Measured: Baseline
Change in Total Scores of IRLS (International Restless Legs Rating Scale)
The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.
The change from baseline was calculated as baseline minus the week 12 value.
Measured: Baseline and final visit (week12)
Change in Global Clinical Impression - Improvement (CGI-I) Scale
The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
Measured: baseline and final visit (week 12)
Frequency of Adverse Events
Frequency of patients with any adverse event, causally related adverse events and serious adverse events
Measured: Up to 16 weeks
Correlation of the Change in IRLS at End of Titration and at Final Visit
Correlation of the change in IRLS at end of titration and at final visit
Measured: Up to 12 weeks

Timeline

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

Sep 2007Oct 2008

First posted24 Jul 2008 (estimated)
Study startSep 2007
Primary completionOct 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 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
Time perspective: Prospective
Enrolment: 549 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00721279
Sponsor's protocol ID: 248.655
Status last verified: May 2014
First submitted: 23 Jul 2008
Last updated: 4 Jun 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

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All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
ClinicalTrials.gov ID: NCT00721279
Acronym / sponsor ID: 248.655
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 549 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Oct 2008 (actual)
First posted: 24 Jul 2008 (estimated)
Results: Posted 8 Jan 2010

Clinical summary

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

Study design

Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with idiopathic RLS

Key inclusion criteria (3 listed)

Primary Restless Legs Syndrome (i.e. idiopathic RLS)
Indication for treatment with pramipexole
Male or female patients older than 18 years

Key exclusion criteria (2 listed)

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
Current treatment with pramipexole

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
Sifrol® (pramipexole dihydrochloride)	Drug	–

Primary outcome

Frequency Analysis for Baseline Pattern of RLS Symptoms
Time frame: Baseline
Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
Change in Total Scores of IRLS (International Restless Legs Rating Scale)
Time frame: Baseline and final visit (week12)
The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value.
Change in Global Clinical Impression - Improvement (CGI-I) Scale
Time frame: baseline and final visit (week 12)
The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
Frequency of Adverse Events
Time frame: Up to 16 weeks
Frequency of patients with any adverse event, causally related adverse events and serious adverse events
Correlation of the Change in IRLS at End of Titration and at Final Visit
Time frame: Up to 12 weeks
Correlation of the change in IRLS at end of titration and at final visit

Results and safety

Results posted to the registry on 8 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
De-novo Patients	452	416
Pre-treated Patients	97	73

Primary outcome: Frequency Analysis for Baseline Pattern of RLS Symptoms

Time frame: Baseline. Number. Unit: percentage of participants

Measure	De-novo Patients n = 440	Pre-treated Patients n = 83
Mild	0.7	2.4
Moderate	19.3	18.1
Severe	62.0	55.4
Very Severe	18.0	24.1

Population analysed: Full analysis set (FAS)

Primary outcome: Change in Total Scores of IRLS (International Restless Legs Rating Scale)

Time frame: Baseline and final visit (week12). Median (Inter-Quartile Range). Unit: scores on a scale

Measure	De-novo Patients n = 428	Pre-treated Patients n = 80
Value	17 (13.00 to 22.00)	16 (11.00 to 22.75)

Population analysed: Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included

Primary outcome: Change in Global Clinical Impression - Improvement (CGI-I) Scale

Time frame: baseline and final visit (week 12). Number. Unit: percentage of participants

Measure	De-novo Patients n = 440	Pre-treated Patients n = 83
Very much improved	47.0	44.6
Much improved	45.5	42.2
Minimally improved	3.0	8.4
No change	1.8	2.4
Minimally worse	0.0	0.0
Much worse	0.2	0.0
Very much worse	0.0	0.0
missing	2.5	2.4

Population analysed: Full analysis set

Primary outcome: Frequency of Adverse Events

Time frame: Up to 16 weeks. Number. Unit: participants

Measure	Overall n = 549
Any adverse event	25
Causally related adverse event	7
serious adverse events	2

Population analysed: Safety Analysis Set (SAF)

Adverse events

Time frame: Up to 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
De-novo Patients	0 of 452 (0%)	0 of 452 (0%)	Not reported
Pre-treated Patients	2 of 97 (2.1%)	0 of 97 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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
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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
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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

127 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 127 sites in Austria.

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 2 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Austria. 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 8 Jan 2010). 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?

Frequency Analysis for Baseline Pattern of RLS Symptoms (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT00721279.

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 4 Jun 2014.