Restless Legs SyndromePhase 3NCT00275457
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
A Phase 3 study testing pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 34 sites in 5 countries.
Trial summary
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension. 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
- 346 participants
- Where
- 34 sitesin 5 countries
- Study dates
- Oct 2002to Apr 2004
- Phase
- Phase 3
- 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
- Male or female out-patients aged 18-80
- Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group. All of the four criteria must be present:
- Irresistible urge to move usually associated with sensory complaints of the lower limbs
- Motor restlessness
- Worsening of the symptoms at rest with at least partial and temporary relief by activity
- Increased severity in the evening or at night
Show all 10Show fewer
- RLS rating scale for severity score > 15
- RLS symptoms present at least 2 to 3 days per week within in the last 3 months
- Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures
- Ability and willingness to comply with study treatment regimen and to attend study assessments
Who cannot join
- Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception or postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection or women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom, or any women not having negative serum pregnancy test at screening
- Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation)
- Patients who are breastfeeding
- Concomitant or previous pharmacologically therapy of RLS as follows:
- Any intake of levodopa within 5 days prior to baseline visit (V2)
- Any intake of dopamine agonists within 14 days prior to baseline visit (V2)
Show all 23Show fewer
- History of any intake of pramipexole
- Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms - withdrawal symptoms caused by stopping any of the drugs above
- Confirmed diagnose of diabetes mellitus requiring insulin therapy
- Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening
- Clinically significant hepatic disease or sGPT > 2 times the upper limit of normal range at screening
- Clinical or laboratory signs of microcytic anaemia at the investigators discretion
- Any of the following lab results at screening:
- Hb or erythrocyte count below lower limit of normal (LLN)
- Basal TSH, T3 or T4 clinically significantly (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion)
- Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease. Poorly controlled cardiovascular disease
- History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms
- Presence of any other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnoea syndrome
- History of Schizophrenia or any psychotic disorder, history of mental disorders due to a general medical condition or any present axis I psychiatric disorder according DSM IV requiring any medical therapy or history of or alcohol abuse or drug addiction within the last 2 years before screening
- Participation in a drug study within two months prior to the start of this study
- History of or clinical signs for any form of epilepsy or seizures apart from fever related seizures in early childhood
- History of or clinical signs of malign neoplasm
- Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
Germany8 sites
Boehringer Ingelheim Investigational Site
Bad Dürrheim-Sunthausen, 78073
Boehringer Ingelheim Investigational Site
Bad Krozingen, 79189
Boehringer Ingelheim Investigational Site
Berlin, 10625
emovis GmbH
Berlin, 10629
Facharzt für Neurologie
Emmendingen, 79312
Boehringer Ingelheim Investigational Site
Kehl, 77694
ClinPharm International GmbH & Co. KG
Leipzig, 04229
Universitätsklinikum Giessen und Marburg
Marburg, 35039
Netherlands8 sites
Boehringer Ingelheim Investigational Site
Beek en Donk, 5741 AR
Boehringer Ingelheim Investigational Site
Deurne, 5751 XJ
Boehringer Ingelheim Investigational Site
Ewijk, 6644 CL
Boehringer Ingelheim Investigational Site
Lichtenvoorde, 7131 CM
Boehringer Ingelheim Investigational Site
Rijswijk, 2281 AK
Boehringer Ingelheim Investigational Site
Roelofarendsveen, 2371 RB
Boehringer Ingelheim Investigational Site
Rotterdam, 3082 DC
Boehringer Ingelheim Investigational Site
The Hague, 2585 LJ
Austria7 sites
Univ.-Klinik für Neurologie
Graz, 8036
Univ.-Klinik für Neurologie
Innsbruck, 6020
AKH der Stadt Linz
Linz, 4021
Confraternität Privatklinik
Vienna, 1080
AKH Universitätsklinik für Psychiatrie
Vienna, 1090
Sonderkrankenanstalt für neurologischen und
Vienna, 1130
Wilhelminenspital der Stadt Wien
Vienna, 1160
Sweden7 sites
Boehringer Ingelheim Investigational Site
Gothenburg, 413 45
Boehringer Ingelheim Investigational Site
Örebro, 701 85
Stockholms Neuro Center
Stockholm, 112 81
Neurologkliniken
Stockholm, 141 86
Boehringer Ingelheim Investigational Site
Uppsala, 751 85
Läkarhuset Vällingby
Vällingby, 162 68
Boehringer Ingelheim Investigational Site
Västra Frölunda, 421 30
Norway4 sites
Boehringer Ingelheim Investigational Site
Hamar, N-2317
Boehringer Ingelheim Investigational Site
Oslo, N-0159
Boehringer Ingelheim Investigational Site
Oslo, N-0303
Boehringer Ingelheim Investigational Site
Tønsberg, N-3111
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.
Read the detailed description
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension
Study Hypotheses:
Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.
Comparison(s):
Pramipexole vs. Placebo
- 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.
Mean change from baseline to week 6 on the RLSRS +
CGI-I responders (much and very much improved)
Secondary outcomes (1)
RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startOct 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 346 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275457
- Sponsor's protocol ID
- 248.520
- Status last verified
- Oct 2013
- First submitted
- 11 Jan 2006
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period
- ClinicalTrials.gov ID
- NCT00275457
- Acronym / sponsor ID
- 248.520
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004
- First posted
- 12 Jan 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.
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.
Detailed description
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension
Study Hypotheses:
Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.
Comparison(s):
Pramipexole vs. Placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female out-patients aged 18-80
- Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group. All of the four criteria must be present:
- RLS rating scale for severity score > 15
- RLS symptoms present at least 2 to 3 days per week within in the last 3 months
- Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures
Key exclusion criteria (23 listed)
- Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception or postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection or women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom, or any women not having negative serum pregnancy test at screening
- Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation)
- Patients who are breastfeeding
- Concomitant or previous pharmacologically therapy of RLS as follows:
- Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms - withdrawal symptoms caused by stopping any of the drugs above
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
Mean change from baseline to week 6 on the RLSRS +
CGI-I responders (much and very much improved)
1 secondary outcome
RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS
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 31 Oct 2013.
- 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 Coordinator study chair
B.I. Pharma GmbH & Co. KG
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 34 sites in 5 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 10 inclusion and 23 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 31 Oct 2013. 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 Germany, Netherlands, Austria, Sweden, Norway. 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?
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?
Mean change from baseline to week 6 on the RLSRS +. The study lists 2 primary outcomes in all. 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 31 Oct 2013.