Restless Legs SyndromePhase 3NCT00654498

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

A Phase 3 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 16 sites in China.

Completed

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

Official record

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Trial summary

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS) 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 306 participants
Where: 16 sitesChina
Study dates: Apr 2008to Jun 2009
Phase: Phase 3
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent consistent with International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) and local legislation given prior to any study procedures.
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 Restless Legs Syndrome (IRLS) according to the clinical Restless Legs Syndrome (RLS) criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
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).

Show all 11Show fewer

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).
Restless Legs Syndrome (RLS)rating scale for severity total score >15.
Restless Legs Syndrome (RLS) symptoms present at least 2 to 3 days per week during the last 3 months.

Who cannot join

Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 2 years after last menses) who do not use during the clinical trial an adequate method of contraception such as: hormonal therapy (combined oral contraceptives, injectables, or subcutaneous implants), hormonal intrauterine devices, sexual abstinence, surgical sterilization of patient and/or partner, hysterectomy, bilateral ovariectomy or partners vasectomy
Any woman of child-bearing potential not having a negative pregnancy test at screening
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 24Show fewer

Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa or dopamine agonists) or anti-dopaminergic drugs, non-selective Monoamine Oxidase (MAO) inhibitors, sympathomimetics, neuroleptics, anti-depressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, Folic acid, vitamin B12, antihistaminics, lithium, metoclopramide or Withdrawal symptoms caused by stopping any of the drugs above
Confirmed diagnose of diabetic nephropathy or clinically significant renal disease
Creatinine higher than upper limit of normal (ULN) at screening
Clinical significant hepatic disease or Alanine aminotransferase (ALT) >2 times the upper limit of normal range at screening
Clinical or laboratory signs of microcytic anaemia, or ferritin in serum below the lower bound of the reference range
Any of the following lab results at screening:
Basal Thyroid Stimulating Hormone (TSH), T3 or T4 clinically significantly (at the investigators discretion) out of normal range at screening (if not caused by substitution therapy according the investigators opinion)
Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion
Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease (such as severe COPD). Poorly controlled cardiovascular disease (including hypotension and severe coronary artery disease)
History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neuro-logical 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, Rapid Eye Movement (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 to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV) requiring any medical therapy
History of 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
Any other conditions that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health hazard for the subject

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

China16 sites

248.630.04 Boehringer Ingelheim Investigational Site
Beijing
248.630.05 Boehringer Ingelheim Investigational Site
Beijing
248.630.06 Boehringer Ingelheim Investigational Site
Beijing
248.630.07 Boehringer Ingelheim Investigational Site
Beijing
248.630.08 Boehringer Ingelheim Investigational Site
Beijing
248.630.15 Boehringer Ingelheim Investigational Site
Guangzhou
248.630.14 Boehringer Ingelheim Investigational Site
Haerbin
248.630.10 Boehringer Ingelheim Investigational Site
Hangzhou
248.630.09 Boehringer Ingelheim Investigational Site
Nanjing
248.630.12 Boehringer Ingelheim Investigational Site
Qingdao
248.630.01 Boehringer Ingelheim Investigational Site
Shanghai
248.630.02 Boehringer Ingelheim Investigational Site
Shanghai
248.630.03 Boehringer Ingelheim Investigational Site
Shanghai
248.630.16 Boehringer Ingelheim Investigational Site
Suzhou
248.630.13 Boehringer Ingelheim Investigational Site
Wuhan
248.630.11 Boehringer Ingelheim Investigational Site
Xian, Shanxi Province

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

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 groups in NCT00654498
Study group	Role	What they receive
Pramipexole	Other	4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily Receives: Drug: Pramipexole
Placebo	Other	4 weeks of individual dose titration as for the investigational product, once daily Receives: Drug: Placebo

What is being measured

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

The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).
The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).
Measured: Baseline and 6 weeks of treatment
The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.
Measured: 6 weeks of treatment

Secondary outcomes (10)

The Proportion of IRLS Responders
responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.
Measured: 6 weeks of treatment
The Proportion of Patient Global Impression(PGI) Responders
PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of "much better" or "very much better".
Measured: 6 weeks of treatment
The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10
The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.
Measured: week 6 of treatment
the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales
RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.
Measured: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.
RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep
Measured: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.
RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the night.
Measured: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.
RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the rest at day.
Measured: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale
RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the activity at day.
Measured: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale
RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the intensity of tiredness and sleepiness at day.
Measured: Baseline and 6 weeks of treatment
The Change From Baseline in Visual Analogue Scales (VAS)
VAS is for assessment of RLS-associated pain. The patient was asked "How severe was your RLS associated pain in legs or arms during the past week?". No pain:0; very worst pain:10
Measured: Baseline and 6 weeks of treatment

Timeline

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

Apr 2008Jun 2009

First posted8 Apr 2008 (estimated)
Study startApr 2008
Primary completionJun 2009
Study completionJun 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654498
Sponsor's protocol ID: 248.630
Status last verified: Mar 2014
First submitted: 27 Mar 2008
Last updated: 9 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 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks
ClinicalTrials.gov ID: NCT00654498
Acronym / sponsor ID: 248.630
Conditions: Restless Legs Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 8 Apr 2008 (estimated)
Results: Posted 3 Mar 2010

Clinical summary

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

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

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	Other	Drug: Pramipexole4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
Placebo	Other	Drug: Placebo4 weeks of individual dose titration as for the investigational product, once daily

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Written informed consent consistent with International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) and local legislation given prior to any study procedures.
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 Restless Legs Syndrome (IRLS) according to the clinical Restless Legs Syndrome (RLS) criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
Restless Legs Syndrome (RLS)rating scale for severity total score >15.

Key exclusion criteria (24 listed)

Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 2 years after last menses) who do not use during the clinical trial an adequate method of contraception such as: hormonal therapy (combined oral contraceptives, injectables, or subcutaneous implants), hormonal intrauterine devices, sexual abstinence, surgical sterilization of patient and/or partner, hysterectomy, bilateral ovariectomy or partners vasectomy
Any woman of child-bearing potential not having a negative pregnancy test at screening
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, e.g. dopaminergic (other than levodopa or dopamine agonists) or anti-dopaminergic drugs, non-selective Monoamine Oxidase (MAO) inhibitors, sympathomimetics, neuroleptics, anti-depressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, Folic acid, vitamin B12, antihistaminics, lithium, metoclopramide or 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	Pramipexole
Placebo	Drug	Placebo

Primary outcome

The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).
Time frame: Baseline and 6 weeks of treatment
The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).
The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"
Time frame: 6 weeks of treatment
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.

10 secondary outcomes

The Proportion of IRLS Responders
Time frame: 6 weeks of treatment
The Proportion of Patient Global Impression(PGI) Responders
Time frame: 6 weeks of treatment
The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10
Time frame: week 6 of treatment
the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales
Time frame: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.
Time frame: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.
Time frame: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.
Time frame: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale
Time frame: Baseline and 6 weeks of treatment
The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale
Time frame: Baseline and 6 weeks of treatment
The Change From Baseline in Visual Analogue Scales (VAS)
Time frame: Baseline and 6 weeks of treatment

Results and safety

Results posted to the registry on 3 Mar 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
Pramipexole	203	189
Placebo	103	91

Primary outcome: The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).

Time frame: Baseline and 6 weeks of treatment. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Pramipexole n = 195	Placebo n = 92
Value	-15.87 (0.66)	-11.35 (0.92)

Pramipexole vs Placebo: Mean Difference (Final Values): -4.52 (95% CI -6.58 to -2.46), p <0.0001, ANCOVA

Population analysed: Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint

Primary outcome: The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"

Time frame: 6 weeks of treatment. Number. Unit: Proportion of Patients

Measure	Pramipexole n = 193	Placebo n = 92
Value	0.819	0.543

Pramipexole vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole	3 of 202 (1.5%)	81 of 202 (40.1%)	Not reported
Placebo	0 of 103 (0%)	25 of 103 (24.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: 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 16 sites in China.

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 11 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 9 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 16 sites in China. 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?

Yes. Results are posted in the registry (first posted 3 Mar 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?

The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS). (time frame: Baseline and 6 weeks of treatment). 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?

On the ClinicalTrials.gov record for NCT00654498.

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 9 Jun 2014.