Restless Legs SyndromePhase 4NCT00349531
A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 49 sites in 9 countries.
Trial summary
The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Pramipexole
- How many people
- 369 participants
- Where
- 49 sitesin 9 countries
- Study dates
- Jul 2006to May 2007
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
- Male or female out-patients aged 18-80 years.
- Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to 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
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- 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. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
- RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
- IRLS total score >15 at baseline (Visit 2).
Who cannot join
- Women of child-bearing potential who do not use during the trial an adequate method of contraception.
- Women of child-bearing potential not having negative pregnancy test at screening.
- Breastfeeding women.
- Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.
- All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
- Withdrawal symptoms.
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- Pramipexole non-responders in other indications than RLS.
- Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
- Diabetes mellitus requiring insulin therapy.
- Any of the following laboratory results at screening:
- any clinically significant abnormalities in laboratory parameters;
- haemoglobin below LLN.
- Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.
- Clinically significant hepatic disease or GPT >2 times the ULN.
- Serum ferritin <10 ng/mL.
- History of/or malignant melanoma.
- History of/or clinically significant vision abnormalities.
- History of/or any other sleep disorder (other than RLS-related).
- History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy.
- History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator's opinion.
- History of/or alcohol abuse or drug addiction (within 2 years).
- Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
- Participation in an investigational drug study within one month.
- Any clinically significant conditions that would interfere or constitute a health hazard for the patient.
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Germany9 sites
248.615.49109 Boehringer Ingelheim Investigational Site
Berlin
248.615.49105 Boehringer Ingelheim Investigational Site
Görlitz
248.615.49108 Boehringer Ingelheim Investigational Site
Hattingen
248.615.49106 Boehringer Ingelheim Investigational Site
München
248.615.49102 Boehringer Ingelheim Investigational Site
Schwerin
248.615.49103 Boehringer Ingelheim Investigational Site
Steglitz
248.615.49101 Boehringer Ingelheim Investigational Site
Ulm
248.615.49107 Boehringer Ingelheim Investigational Site
Witten
248.615.49104 Boehringer Ingelheim Investigational Site
Würzburg
Italy8 sites
248.615.39007 Policlinico di Bari - Università di Bari
Bari
248.615.39006 Ospedale Civile di Dolo
Dolo (VE)
248.615.39002 Ospedale S. Martino - A. O. Università di Genova
Genova
248.615.39008 Policlinico Gaetano Martino
Messina
248.615.39001 Istituto San Raffaele Turro
Milan
248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"
Pavia
248.615.39005 Ospedale S. Chiara
Pisa
248.615.39003 A. O. Santa Maria della Misericordia
Udine
Spain6 sites
248.615.3408 Hospital Nuestra Señora de Sonsoles
Ávila
248.615.3402
Maderid
248.615.3404 Hospital General Universitario Gregorio Marañón
Madrid
248.615.3406
Madrid
248.615.3407
Madrid
248.615.3403 Hospital General de Catalunya
San Cugat Del Valles (Barcelona)
United Kingdom6 sites
248.615.44006 Boehringer Ingelheim Investigational Site
Buckshaw Village, Chorley
248.615.44004 Boehringer Ingelheim Investigational Site
Cambridge
248.615.44007 Boehringer Ingelheim Investigational Site
Manchester
248.615.44009 Boehringer Ingelheim Investigational Site
Reading
248.615.44002 Boehringer Ingelheim Investigational Site
Romford
248.615.44005 Boehringer Ingelheim Investigational Site
West Green, Crawley
Norway5 sites
248.615.47101 Boehringer Ingelheim Investigational Site
Bekkestua
248.615.47102 Boehringer Ingelheim Investigational Site
Fevik
248.615.47104 Boehringer Ingelheim Investigational Site
Moelv
248.615.47103 Boehringer Ingelheim Investigational Site
Oslo
248.615.47105 Boehringer Ingelheim Investigational Site
Tvedestrand
Denmark4 sites
248.615.45102 Boehringer Ingelheim Investigational Site
København K
248.615.45101 Boehringer Ingelheim Investigational Site
København NV
248.615.45103 Boehringer Ingelheim Investigational Site
Kongens Lyngby
248.615.45104 Boehringer Ingelheim Investigational Site
Vaerløse
Finland4 sites
248.615.35101 Boehringer Ingelheim Investigational Site
Espoo
248.615.35104 Boehringer Ingelheim Investigational Site
Joensuu
248.615.35103 Boehringer Ingelheim Investigational Site
Lahti
248.615.35102 Boehringer Ingelheim Investigational Site
Oulu
Sweden4 sites
248.615.46101 Boehringer Ingelheim Investigational Site
Gothenburg
248.615.46103 Boehringer Ingelheim Investigational Site
Gothenburg
248.615.46102 Boehringer Ingelheim Investigational Site
Hedemora
248.615.46104 Boehringer Ingelheim Investigational Site
Örebro
Ireland3 sites
248.615.35302
Birr
248.615.35301 Boehringer Ingelheim Investigational Site
Carrigtohill
248.615.35303
Castlecomer
About this study
Official title: A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome
The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome
- Being tested
- Pramipexole
- 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.
PramipexoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: change from baseline after 12 weeks in IRLS total score. Co-primary endpoint: change from baseline after 12 weeks in MOS sleep disturbance score.
Measured: 12 weeks after start of treatment
Secondary outcomes (1)
Secondary endpoints: CGI-I and IRLS responder rate other MOS dimensions, RLS-6 items 4-6, IRLS item 10, VAS ,Verbal Fluency Tests ,RLS-QoL scores PGI responder rate adverse event profile, systolic and diastolic blood pressure, pulse rate
Measured: 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2007
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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349531
- Sponsor's protocol ID
- 248.615
- Status last verified
- May 2012
- First submitted
- 6 Jul 2006
- Last updated
- 21 May 2012
- Results posted
- No
Publications
Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.
PubMed 21256799
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-patients With Idiopathic Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00349531
- Acronym / sponsor ID
- 248.615
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2007 (actual)
- First posted
- 7 Jul 2006 (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 primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
- Male or female out-patients aged 18-80 years.
- Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
- RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
- IRLS total score >15 at baseline (Visit 2).
Key exclusion criteria (24 listed)
- Women of child-bearing potential who do not use during the trial an adequate method of contraception.
- Women of child-bearing potential not having negative pregnancy test at screening.
- Breastfeeding women.
- Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.
- All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
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 | Drug | – |
Primary outcome
Primary endpoint: change from baseline after 12 weeks in IRLS total score. Co-primary endpoint: change from baseline after 12 weeks in MOS sleep disturbance score.
Time frame: 12 weeks after start of treatment
1 secondary outcome
Secondary endpoints: CGI-I and IRLS responder rate other MOS dimensions, RLS-6 items 4-6, IRLS item 10, VAS ,Verbal Fluency Tests ,RLS-QoL scores PGI responder rate adverse event profile, systolic and diastolic blood pressure, pulse rate
Time frame: 12 weeks after start of treatment
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 21 May 2012.
- Derived from this study: PubMed 21256799Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.
- 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
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 49 sites in 9 countries.
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 9 inclusion and 24 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany, Italy, Spain, United Kingdom, Norway and 4 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: change from baseline after 12 weeks in IRLS total score. Co-primary endpoint: change from baseline after 12 weeks in MOS sleep disturbance score. (time frame: 12 weeks after start of treatment). 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 NCT00349531, 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 21 May 2012.