Restless Legs SyndromePhase 4NCT00356096
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
A Phase 4 study testing pramipexole in people with Restless Legs Syndrome and Depression, run by Boehringer Ingelheim at 54 sites in 9 countries.
Trial summary
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Restless Legs Syndrome, Depression
- What is being tested?
- pramipexole
- How many people
- 404 participants
- Where
- 54 sitesin 9 countries
- Study dates
- Jul 2006to Jun 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 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).
- In addition all of the following must be demonstrated at Visit 2 (baseline):
- IRLS total score >15 A score of >=2 for item 10 of the IRLS rating scale
Who cannot join
- Women of child-bearing potential who do not use an adequate method of contraception
- Any women of child-bearing potential not having negative pregnancy test at screening
- Breastfeeding women
- Concomitant or previous pharmacologic therapy for RLS
- All treatment less than 14 days before baseline or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms
- Withdrawal symptoms of any medication must not be present at baseline
Show all 22Show fewer
- Previous pramipexole non-responders in other indications than RLS.
- Hypersensitivity to pramipexole or any other component of the investigational product
- Diagnosis of diabetes mellitus requiring insulin
- Any of the following laboratory results at screening: clinically significant abnormalities at the investigatos discretion; Hb below lower limit of normal
- Clinically significant renal disease at screening
- Clinically significant hepatic disease at screening
- Serum ferritin <10 ng/mL at screening.
- History of/or malignant melanoma.
- History of/or clinically significant vision abnormalities
- History of/or any other sleep disorder
- 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, or BDI-II total score >28
- History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigators opinion
- History of/or alcohol abuse or drug addiction within the last 2 years before screening
- Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake cycle
- Participation in an investigational drug study within one month prior to the start of this study
- Patients with any clinically significant conditions that in the opinion of the investigator
Trial locations and contacts
54 sites in 9 countries.
54 sites in 9 countries
Germany11 sites
248.604.4902 Boehringer Ingelheim Investigational Site
Berlin
248.604.4904 Boehringer Ingelheim Investigational Site
Berlin
248.604.4905 Boehringer Ingelheim Investigational Site
Berlin
248.604.4906 Boehringer Ingelheim Investigational Site
Berlin
248.604.4909 Boehringer Ingelheim Investigational Site
Chemnitz
248.604.4901 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
248.604.4903 Boehringer Ingelheim Investigational Site
Hellersdorf
248.604.4907 Boehringer Ingelheim Investigational Site
Kassel
248.604.4910 Boehringer Ingelheim Investigational Site
Leipzig
248.604.4908 Boehringer Ingelheim Investigational Site
Marburg
248.604.4911 Boehringer Ingelheim Investigational Site
München
France7 sites
248.604.3301A HOP Le Vinatier,Psychiat,Bron
Bron
248.604.3304B Hôpital Roger Salengro
Lille
248.604.3307A Cabinet Médical
Montbrison
248.604.3303A Hôpital Gui de Chauliac
Montpellier Cédex 5
248.604.3303C Hôpital Gui de Chauliac
Montpellier Cédex 5
248.604.3302A Hôpital Pitié Salpétrière
Paris Cédex 13
248.604.3305B Hôpital du Haut Levêque
Pessac Cédex
Italy7 sites
248.604.3901 Università degli Studi di Bologna
Bologna
248.604.3905 Casa di Cura Villa Serena
Città S. Angelo (PE)
248.604.3906 Clinica Psichiatrica
Pisa
248.604.3902 IRCCS San Raffaele
Roma
248.604.3909 IRCCS Fondazione "Salvatore Maugeri"
Telese Terme (be)
248.604.3908 Azienda Sanitaria San Giovanni Battista
Torino
248.604.3904 IRCCS Oasi Maria SS
Troina (Enna)
United Kingdom7 sites
248.604.44004 Boehringer Ingelheim Investigational Site
Cambridge
248.604.44006 Boehringer Ingelheim Investigational Site
Chorley
248.604.44001 Boehringer Ingelheim Investigational Site
London
248.604.44007 Boehringer Ingelheim Investigational Site
Manchester
248.604.44009 Boehringer Ingelheim Investigational Site
Reading
248.604.44002 Boehringer Ingelheim Investigational Site
Romford
248.604.44005 Boehringer Ingelheim Investigational Site
West Green, Crawley
Spain6 sites
248.604.3401
Madrid
248.604.3403
Madrid
248.604.3405
Madrid
248.604.3407
Oviedo
248.604.3402
San Cugat Del Vallés (Barcelona)
248.604.3404 Hospital de Donostia
San Sebastián
Sweden6 sites
248.604.4602 Boehringer Ingelheim Investigational Site
Gothenburg
248.604.4603 Boehringer Ingelheim Investigational Site
Gothenburg
248.604.4601 Boehringer Ingelheim Investigational Site
Hedemora
248.604.4605 Boehringer Ingelheim Investigational Site
Örebro
248.604.4604 Boehringer Ingelheim Investigational Site
Skövde
248.604.4606 Boehringer Ingelheim Investigational Site
Stockholm
Finland4 sites
248.604.35801 Boehringer Ingelheim Investigational Site
Espoo
248.604.35805 Boehringer Ingelheim Investigational Site
Helsinki
248.604.35803 Boehringer Ingelheim Investigational Site
Lahti
248.604.35802 Boehringer Ingelheim Investigational Site
Oulu
South Korea4 sites
248.604.82001 Boehringer Ingelheim Investigational Site
Daegu
248.604.82003 Boehringer Ingelheim Investigational Site
Incheon
248.604.82002 Boehringer Ingelheim Investigational Site
Seoul
248.604.82004 Boehringer Ingelheim Investigational Site
Seoul
Ireland2 sites
248.604.35305
Carrigtohill
248.604.35302 Boehringer Ingelheim Investigational Site
Castledermot
About this study
Official title: A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
- Conditions
- Restless Legs Syndrome, Depression
- Being tested
- pramipexole
- Medical subject headings
- Restless Legs Syndrome, Depression
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.
The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score
Measured: 12 weeks
Secondary outcomes (1)
The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJun 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
- 404 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
- NCT00356096
- Sponsor's protocol ID
- 248.604
- Status last verified
- May 2012
- First submitted
- 24 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 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances
- ClinicalTrials.gov ID
- NCT00356096
- Acronym / sponsor ID
- 248.604
- Conditions
- Restless Legs Syndrome, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- First posted
- 25 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 determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
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 (7 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:
- 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 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).
Key exclusion criteria (22 listed)
- Women of child-bearing potential who do not use an adequate method of contraception
- Any women of child-bearing potential not having negative pregnancy test at screening
- Breastfeeding women
- Concomitant or previous pharmacologic therapy for RLS
- All treatment less than 14 days before baseline 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
The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score
Time frame: 12 weeks
1 secondary outcome
The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate
Time frame: 12 weeks
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.
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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
54 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 and Depression, run by Boehringer Ingelheim at 54 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 7 inclusion and 22 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 54 sites in Germany, France, Italy, United Kingdom, Spain 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?
The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score (time frame: 12 weeks). 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 NCT00356096, 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.