Restless Legs SyndromePhase 4NCT00472199
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 42 sites in 9 countries.
Trial summary
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Pramipexole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 331 participants
- Where
- 42 sitesin 9 countries
- Study dates
- May 2007to Jul 2008
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (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 18-85 years
- Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (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)
Who cannot join
- Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization
- Any woman of child-bearing potential not having a negative pregnancy test at screening
- Breastfeeding women
- Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
- Diagnosis of augmentation under previous pharmacological RLS treatment
- Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);
Trial locations and contacts
42 sites in 9 countries.
42 sites in 9 countries
Germany9 sites
248.629.4902 Boehringer Ingelheim Investigational Site
Berlin
248.629.4908 Boehringer Ingelheim Investigational Site
Bochum
248.629.4901 Boehringer Ingelheim Investigational Site
Ellwangen
248.629.4904 Boehringer Ingelheim Investigational Site
Hellersdorf
248.629.4906 Boehringer Ingelheim Investigational Site
Herborn
248.629.4905 Boehringer Ingelheim Investigational Site
Leipzig
248.629.4909 Boehringer Ingelheim Investigational Site
Schwerin
248.629.4903 Boehringer Ingelheim Investigational Site
Steglitz
248.629.4907 Boehringer Ingelheim Investigational Site
Würzburg
Netherlands6 sites
248.629.31001 Boehringer Ingelheim Investigational Site
Bennebroek
248.629.31005 Boehringer Ingelheim Investigational Site
Hoogwoud
248.629.31006 Boehringer Ingelheim Investigational Site
Musselkanaal
248.629.31002 Boehringer Ingelheim Investigational Site
Oude Pekela
248.629.31003 Boehringer Ingelheim Investigational Site
Oude Pekela
248.629.31004 Boehringer Ingelheim Investigational Site
Rijswijk
United Kingdom6 sites
248.629.44003 Boehringer Ingelheim Investigational Site
Chorley
248.629.44006 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham
248.629.44004 Boehringer Ingelheim Investigational Site
Glasgow
248.629.44001 Boehringer Ingelheim Investigational Site
Manchester
248.629.44002 Boehringer Ingelheim Investigational Site
Reading
248.629.44005 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool
Finland5 sites
248.629.35801 Boehringer Ingelheim Investigational Site
Espoo
248.629.35805 Boehringer Ingelheim Investigational Site
Helsinki
248.629.35804 Boehringer Ingelheim Investigational Site
Joensuu
248.629.35802 Boehringer Ingelheim Investigational Site
Oulu
248.629.35806 Boehringer Ingelheim Investigational Site
Tampere
Slovakia5 sites
248.629.4204 Boehringer Ingelheim Investigational Site
Bratislava
248.629.4205 Boehringer Ingelheim Investigational Site
Bratislava
248.629.4202 Boehringer Ingelheim Investigational Site
Brezno
248.629.4201 Boehringer Ingelheim Investigational Site
Košice
248.629.4203 Boehringer Ingelheim Investigational Site
Martin
Spain5 sites
248.629.3402 Boehringer Ingelheim Investigational Site
Barcelona
248.629.3405 Boehringer Ingelheim Investigational Site
Granada
248.629.3401 Boehringer Ingelheim Investigational Site
Madrid
248.629.3403 Boehringer Ingelheim Investigational Site
San Sebastián
248.629.3406 Hospital Arnau de Vilanova
Valencia
Ireland3 sites
248.629.35301 Boehringer Ingelheim Investigational Site
Carrigtohill
248.629.35302 Boehringer Ingelheim Investigational Site
Co. Kildare
248.629.35303 Boehringer Ingelheim Investigational Site
Co. Tipperary
Austria2 sites
248.629.4302 Boehringer Ingelheim Investigational Site
Innsbruck
248.629.4304 Boehringer Ingelheim Investigational Site
Linz
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 to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo.
The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.
- Conditions
- Restless Legs Syndrome
- Being tested
- Pramipexole, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole | Experimental | 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. Receives: Drug: Pramipexole |
| Placebo | Placebo comparator | 4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
Measured: Baseline and 26 weeks
Secondary outcomes (30)
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)
Measured: after 26 weeks of treatment
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate
IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)
Measured: after 26 weeks of treatment
Patient Global Impression (PGI) Responder Rate
PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)
Measured: after 26 weeks of treatment
Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks
The question was rated on an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: Baseline and 26 weeks of treatment
Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks
The score is an 11-point Likert scale, ranging from "none/not at all" (0) to "very severe" (10), to reflect the patient's condition during the previous week
Measured: Baseline and 26 weeks of treatment
Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks
Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)
Measured: Baseline and 26 weeks of treatment
Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks
The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)
Measured: Baseline and 26 weeks of treatment
Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks
RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life
Measured: Baseline and 26 weeks of treatment
Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less bodily pain
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension General Health After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health status
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better mental health
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better physical functioning
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better social functioning
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Vitality After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better vitality
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health
Measured: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks
Score ranging from 0 to 100 with higher scores indicating better health
Measured: Baseline and 26 weeks
Diagnosis of Classified Augmentation According to Independent Expert Panel
Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.
Measured: after at least 4 weeks of treatment
Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation
Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).
Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline.
Measured: after at least 1 week of treatment discontinuation
Baseline, Week 26 Mean Supine Systolic Blood Pressure
Measured: Baseline, Week 26
Baseline, Week 26 Mean Standing Systolic Blood Pressure
Measured: Baseline, Week 26
Baseline, Week 26 Mean Supine Diastolic Blood Pressure
Measured: Baseline, Week 26
Baseline, Week 26 Mean Standing Diastolic Blood Pressure
Measured: Baseline, Week 26
Baseline, Week 26 Mean Supine Pulse Rate
Measured: Baseline, Week 26
Baseline, Week 26 Mean Standing Pulse Rate
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionJul 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472199
- Sponsor's protocol ID
- 248.629
- Other IDs
- EUDRACT2006-006431-42
- Status last verified
- May 2012
- First submitted
- 10 May 2007
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. 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 to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period
- ClinicalTrials.gov ID
- NCT00472199
- Acronym / sponsor ID
- 248.629
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Posted 17 Nov 2009
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 the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo.
The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole | Experimental | Drug: Pramipexole4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. |
| Placebo | Placebo comparator | Drug: Placebo4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (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 18-85 years
- Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (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 (6 listed)
- Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization
- Any woman of child-bearing potential not having a negative pregnancy test at screening
- Breastfeeding women
- Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
- Diagnosis of augmentation under previous pharmacological RLS treatment
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 | Pramipexole |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks
Time frame: Baseline and 26 weeks
IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)
30 secondary outcomes
Clinical Global Impression - Global Improvement (CGI-I) Responder Rate
Time frame: after 26 weeks of treatment
International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate
Time frame: after 26 weeks of treatment
Patient Global Impression (PGI) Responder Rate
Time frame: after 26 weeks of treatment
Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks
Time frame: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks
Time frame: baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks
Time frame: Baseline and 26 weeks of treatment
Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension General Health After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Vitality After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks
Time frame: Baseline and 26 weeks
Diagnosis of Classified Augmentation According to Independent Expert Panel
Time frame: after at least 4 weeks of treatment
Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation
Time frame: after at least 1 week of treatment discontinuation
Baseline, Week 26 Mean Supine Systolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Systolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Supine Diastolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Diastolic Blood Pressure
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Supine Pulse Rate
Time frame: Baseline, Week 26
Baseline, Week 26 Mean Standing Pulse Rate
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
42 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 42 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 5 inclusion and 6 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 27 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 42 sites in Germany, Netherlands, United Kingdom, Finland, Slovakia 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2009). 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?
Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks (time frame: Baseline and 26 weeks). 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 27 Jun 2014.