Restless Legs SyndromeNCT00867893
Suggested Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
An observational study of Restless Legs Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
Some medications used to treat the restless legs syndrome (RLS) when taken for some time make the condition worse. This study seeks to find a method for early detection of this problem so that it can either be prevented or corrected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RLS patients treated with medication
Who may be able to join
- Primary RLS (exclude all secondary RLS including those related to neuropathies and medications)
- Adult and adolescents 18 years of age or older
- One of the following 2 criteria must be met:
- RLS treatment with either ropinirole or pramipexole or with a non-DA treatment (opioid or GABA active hypnotic), with the first dose each day taken at or before 4:30 PM. (Note this allows patients to be entered who had the usual tapered withdrawal from another medication with a concurrent gradual start of the DA agonist or opioid over a period of up to 12 months. In all such cases the initial evaluations must occur at least 6 weeks after discontinuing any prior drug treatment.) OR
- Off all RLS medication treatments for at least 6 weeks AND planning on starting DA agonist or a non-DA treatment (opioid or GABA active hypnotic) as the only RLS medication treatment.
Who cannot join
- Pregnant or lactating.
- Inadequate birth control if female and able to become pregnant.
- History of allergic reaction to diphenhydramine.
- History of major psychiatric or chronic neurological disorder that would affect RLS treatment or judgment. These include but are not limited to bipolar depression, major affective disorder, schizophrenia, obsessive-compulsive disorder, and all neurodegenerative diseases.
- History of another major sleep disorder other than RLS and insomnia: narcolepsy, significant sleep-disordered breathing (DBR>15/hr), and circadian rhythm disorder.
- History of use of dopamine antagonist within the last year for any reason other than treating nausea.
- History of use of tramadol within the last 3 months.
- Unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: d Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
Some medications used to treat the restless legs syndrome (RLS) when taken for some time make the condition worse. This study seeks to find a method for early detection of this problem so that it can either be prevented or corrected.
Read the detailed description
Long term dopaminergic treatment of RLS produces an exacerbation of RLS symptoms worse than before treatment for a significant percentage (5 - 70%) of those treated. This appears to be related to half-life, dose and duration of treatment. Shorter half-life medications appear to produce more augmentation. Once started augmentation appears to be progressive in many of the patients with the end result that the patient has much more severe RLS symptoms than before treatment. These symptoms can still be temporarily reduced by adding more dopaminergic treatment, but eventually this fails to suffice even with very high dopaminergic doses. The problem is finding a way to detect augmentation early during dopamine treatment both to determine the true rate of occurrence of this problem and to change treatment strategies before the problem becomes severe.
The suggested immobilization test creates the stimulus situation of protracted rest while lying down that provokes RLS symptoms. It provides a sensitive test for the severity of the symptom.. It should therefore provide an early detection of any exacerbation of symptoms such as that occurring with RLS augmentation.
In addition diphenhydramine also creates an exacerbation of RLS symptoms. This exacerbation would amplify the current severity of the RLS and as such could provide a tool for enhancing the degree of augmentation. Thus testing with a diphenhydramine challenge dose before the SIT test could provide an even more sensitive measure of augmentation
The investigators specifically hypothesize:
- The objective measures from the SIT test will reveal an increase in severity of RLS that occurs with RLS augmentation at the same time or before the augmentation is detected by the usual subjective clinical assessments.
- An oral dose of 25 mg of diphenhydramine taken 45 minutes before a SIT test will amplify the augmentation effects shown on the objective measures of the SIT. This will provide an enhanced detection of augmentation before or at the same time as that detected by either the SIT test alone or the clinical evaluation.
This study may for the first time provide a standard highly repeatable objective measure of RLS augmentation that is as or more sensitive as a very careful clinical evaluation by someone well trained in detecting RLS augmentation. As such it would prove clinically useful to evaluate RLS treatment progress. It would also provide an efficient method for evaluating the augmentation potential of new medications for RLS. .
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| DA group | RLS patients started treatment on dopamine agonists within the past year | |
| NonDA | RLS patients started treatment on medication other than dopamine agonists within the past year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodic Leg Movement/Hour on SIT PSG
Occurs one month after Baseline SIT.
Measured: 1 Month
Periodic Leg Movement/Hour on SIT PSG
Occurs 2 months after Baseline SIT.
Measured: 2 Month
Periodic Leg Movement/Hour on SIT PSG
Occurs 4 months after Baseline SIT.
Measured: 4 Month
Periodic Leg Movement/Hour on SIT PSG
Occurs 6 months after Baseline SIT.
Measured: Month 6
Periodic Leg Movement/Hour on SIT PSG
Occurs 9 months after Baseline SIT.
Measured: Month 9
Periodic Leg Movement/Hour on SIT PSG
Occurs 12 months after Baseline SIT.
Measured: 12 Month
Periodic Leg Movement/Hour on SIT PSG
First SIT used as a baseline, 1 or 2 days depending on participant's past experience with the test.
Measured: 0 months/Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2012
- Study completionJul 2012
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 Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Allen, Johns Hopkins University
- Investigators
- Richard P Allen, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867893
- Sponsor's protocol ID
- Sit-AUG
- Status last verified
- Aug 2012
- First submitted
- 23 Mar 2009
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- d Immobilization Test (SIT) Test for Early Detection of Restless Legs Syndrome (RLS) Augmentation - Proof of Concept
- ClinicalTrials.gov ID
- NCT00867893
- Acronym / sponsor ID
- Sit-AUG
- Conditions
- Restless Legs Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Mar 2009 (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.
Some medications used to treat the restless legs syndrome (RLS) when taken for some time make the condition worse. This study seeks to find a method for early detection of this problem so that it can either be prevented or corrected.
Detailed description
Long term dopaminergic treatment of RLS produces an exacerbation of RLS symptoms worse than before treatment for a significant percentage (5 - 70%) of those treated. This appears to be related to half-life, dose and duration of treatment. Shorter half-life medications appear to produce more augmentation. Once started augmentation appears to be progressive in many of the patients with the end result that the patient has much more severe RLS symptoms than before treatment. These symptoms can still be temporarily reduced by adding more dopaminergic treatment, but eventually this fails to suffice even with very high dopaminergic doses. The problem is finding a way to detect augmentation early during dopamine treatment both to determine the true rate of occurrence of this problem and to change treatment strategies before the problem becomes severe.
The suggested immobilization test creates the stimulus situation of protracted rest while lying down that provokes RLS symptoms. It provides a sensitive test for the severity of the symptom.. It should therefore provide an early detection of any exacerbation of symptoms such as that occurring with RLS augmentation.
In addition diphenhydramine also creates an exacerbation of RLS symptoms. This exacerbation would amplify the current severity of the RLS and as such could provide a tool for enhancing the degree of augmentation. Thus testing with a diphenhydramine challenge dose before the SIT test could provide an even more sensitive measure of augmentation
The investigators specifically hypothesize:
- The objective measures from the SIT test will reveal an increase in severity of RLS that occurs with RLS augmentation at the same time or before the augmentation is detected by the usual subjective clinical assessments.
- An oral dose of 25 mg of diphenhydramine taken 45 minutes before a SIT test will amplify the augmentation effects shown on the objective measures of the SIT. This will provide an enhanced detection of augmentation before or at the same time as that detected by either the SIT test alone or the clinical evaluation.
This study may for the first time provide a standard highly repeatable objective measure of RLS augmentation that is as or more sensitive as a very careful clinical evaluation by someone well trained in detecting RLS augmentation. As such it would prove clinically useful to evaluate RLS treatment progress. It would also provide an efficient method for evaluating the augmentation potential of new medications for RLS. .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA group | – | –RLS patients started treatment on dopamine agonists within the past year |
| NonDA | – | –RLS patients started treatment on medication other than dopamine agonists within the past year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RLS patients treated with medication
Key inclusion criteria (5 listed)
- Primary RLS (exclude all secondary RLS including those related to neuropathies and medications)
- Adult and adolescents 18 years of age or older
- One of the following 2 criteria must be met:
Key exclusion criteria (8 listed)
- Pregnant or lactating.
- Inadequate birth control if female and able to become pregnant.
- History of allergic reaction to diphenhydramine.
- History of major psychiatric or chronic neurological disorder that would affect RLS treatment or judgment. These include but are not limited to bipolar depression, major affective disorder, schizophrenia, obsessive-compulsive disorder, and all neurodegenerative diseases.
- History of another major sleep disorder other than RLS and insomnia: narcolepsy, significant sleep-disordered breathing (DBR>15/hr), and circadian rhythm disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periodic Leg Movement/Hour on SIT PSG
Time frame: 1 Month
Occurs one month after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: 2 Month
Occurs 2 months after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: 4 Month
Occurs 4 months after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: Month 6
Occurs 6 months after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: Month 9
Occurs 9 months after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: 12 Month
Occurs 12 months after Baseline SIT.
Periodic Leg Movement/Hour on SIT PSG
Time frame: 0 months/Baseline
First SIT used as a baseline, 1 or 2 days depending on participant's past experience with the test.
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 14 Aug 2012.
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
Richard P Allen, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Johns Hopkins University at 1 site in United States.
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 8 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Periodic Leg Movement/Hour on SIT PSG (time frame: 1 Month). The study lists 7 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 14 Aug 2012.