Restless Legs SyndromePhase 4AUTORESTNCT02025608
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Mauro Manconi at 2 sites in Switzerland.
Trial summary
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- 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
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2013to 31 Dec 2016
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate and written informed consent
- Aged 30 to 65 years at the time of screening
- Body mass index (BMI) ≤ 30
- Unremarkable neurological and physical examination
- Unremarkable standard blood parameter according to local reference values
- Additional Inclusion Criteria for Restless Legs Syndrome (RLS) Patients:
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- RLS according to current standard international criteria
- RLS symptoms ≥ 2 times per week for ≥ 1 year and during the past 12 months.
- Either current international RLS severity scale (IRLS) ≥ 15 or current IRLS ≥ 10 and RLS symptoms ≥ 4 times per week during the past 3 months.
Who cannot join
- Pregnancy, or breast feeding at time of screening.
- Recent anaesthesia (last 3 months).
- Sleep related breathing disorders during nocturnal polysomnography:
- Current history of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Life time history of any diagnosis of, medication or intervention for cardiovascular diseases.
- Current chronic treatment that may affect autonomic function.
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- Any significant neurological disease or diagnosed metabolic diseases that may affect cardiovascular function and/or increase cardiovascular risk.
- Any unstable medical condition.
- Smoking > 5 cigarettes per day during the last 2 years.
- Work involving night shifts (22:00 - 06:00 h) during the past 2 years.
- Travel with > 6 time zone differences during the past 6 months.
- Participation in any other study involving investigational or marketed products concomitantly or within 3 months prior to the screening visit.
- Current participation in other clinical trials.
- Additional Exclusion Criteria for RLS Patients
- Exposure to dopaminergic drugs > 12 months during life time and/or > 1 week during the past 3 months and/or current or during the past month.
- Exposure to other RLS relevant medication (such as opioids, antiepileptics, clonidine except hypnotics such as benzodiazepines) > 24 months during life time and/or > 1 week during the past 3 months and/or current intake.
- Intake of hypnotics (such as benzodiazepines) during the past month.
- Other significant sleep disorder except symptoms potentially related to RLS such as insomnia and daytime sleepiness.
- Any contraindication or known hypersensitivity to dopaminergic drugs.
- Additional Exclusion Criteria for Control Subjects
- Any pharmacological treatment that may affect sleep and/or sleep related movement disorders during the last 3 months.
- Any clinically significant sleep disorders according to the International Classification of Sleep Disorders (ICSD)12.
- Increased daytime sleepiness as indicated by an Epworth Sleepiness Scale (ESS) score > 11.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neurology, Inselspital
Bern, 3010
Neurocenter of Southern Switzerland
Lugano, Canton Ticino, 6903
About this study
Official title: Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week, Multicenter Study of 0.25mg Pramipexole vs. Placebo in Patients With RLS
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
- Conditions
- Restless Legs Syndrome
- Being tested
- Pramipexole, Placebo
- Keywords
- Restless legs syndrome
- 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 | Pramipexole, 0.25 mg, daily for 4 weeks Receives: Drug: Pramipexole |
| Placebo | Placebo comparator | Placebo, daily for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate activations during sleep from baseline to 4 weeks
Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep
Measured: Baseline, Week 4
Secondary outcomes (2)
Change in baroreflex from baseline to 4 weeks
Baroreflex sensitivity and baroreflex gain derived from tilt table tes
Measured: Baseline, Week 4
Change in blood serum markers from baseline to 4 weeks
Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauro Manconi
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Cardiocentro Ticino
- Responsible party
- Sponsor-investigator, Mauro Manconi, Ospedale Regionale di Lugano
- Investigators
- Mauro Manconi, PhD, MD, Principal investigator, Neurocenter of Southern SwitzerlandClaudio L.A. Bassetti, MD, Principal investigator, Department of Neurology, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025608
- Sponsor's protocol ID
- NSI.13.01
- Other IDs
- 320030_144007
- Acronym
- AUTOREST
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week, Multicenter Study of 0.25mg Pramipexole vs. Placebo in Patients With RLS
- ClinicalTrials.gov ID
- NCT02025608
- Acronym / sponsor ID
- AUTOREST / NSI.13.01
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless legs syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mauro ManconiUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Cardiocentro Ticino
- Study start
- Dec 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 1 Jan 2014 (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 purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
Study design
- Primary purpose
- Other
- 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: PramipexolePramipexole, 0.25 mg, daily for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, daily for 4 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willingness to participate and written informed consent
- Aged 30 to 65 years at the time of screening
- Body mass index (BMI) ≤ 30
- Unremarkable neurological and physical examination
- Unremarkable standard blood parameter according to local reference values
Key exclusion criteria (23 listed)
- Pregnancy, or breast feeding at time of screening.
- Recent anaesthesia (last 3 months).
- Sleep related breathing disorders during nocturnal polysomnography:
- Current history of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Life time history of any diagnosis of, medication or intervention for cardiovascular diseases.
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 in heart rate activations during sleep from baseline to 4 weeks
Time frame: Baseline, Week 4
Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep
2 secondary outcomes
Change in baroreflex from baseline to 4 weeks
Time frame: Baseline, Week 4
Change in blood serum markers from baseline to 4 weeks
Time frame: Baseline, Week 4
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 24 Jan 2017.
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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.
Mauro Manconi, PhD, MD principal investigator
Neurocenter of Southern Switzerland
Claudio L.A. Bassetti, MD principal investigator
Department of Neurology, Inselspital
2 sites in 1 country: 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 Mauro Manconi at 2 sites in Switzerland.
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 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
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?
Change in heart rate activations during sleep from baseline to 4 weeks (time frame: Baseline, Week 4). 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 24 Jan 2017.