Restless Legs SyndromePhase 4ButransNCT02138357
Butrans for Treatment of Restless Legs Syndrome
A Phase 4 study testing buprenorphine transdermal delivery system (BTDS) in people with Restless Legs Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- buprenorphine transdermal delivery system (BTDS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of RLS, defined by International Restless Legs Study Group (IRLS) essential criteria:
- An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
- The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down 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.
- Subject has moderate to severe RLS symptoms,defined as an International Restless Legs Scale (IRLS) score greater than or equal to15 at the baseline visit (visit 2).
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- Subject has RLS symptoms that, in the opinion of the investigator, require round-the-clock treatment.
- Subject speaks and reads English.
- Subject is able to provide informed consent.
- Subject is age ≥25 and ≤75.
- Subject has BMI ≥18 and ≤35
- Subject is naïve to opioid treatment, defined as subjects not having received ≥5 mg oxycodone in the past 14 days and no history of daily use of ≥5 mg oxycodone equivalents in the past 3 months.
- If subject is currently being treated for RLS, s/he must have an inadequate response to or be intolerant of current, non-opioid regimen.
- If subject is not currently being treated for RLS, s/he must have a contraindication to or a history of intolerance to non-opioid treatment options for RLS, concerns about side effects of such options, or a preference for non-oral medication.
- If subject is currently being treated with a medication for RLS, a washout period of at least 3 days will be required (or 5 half-lives for longer-acting agents).
- Subject's history and/or clinical records document no change in medications active in the central nervous system (antidepressants, analgesics, antipsychotics, antiepileptics, hypnotics, etc.) for at least 30 days prior to visit 1.
- Subject is able to understand study procedures and agrees to remain on stable medications during the period of the study.
- Women of childbearing potential must agree to use a medically accepted method of birth control. Acceptable forms of birth control include:
- Condom + spermicide
- Diaphragm + spermicide
- Oral contraceptive pills, hormone implants (like Norplant), or injections(like Depo-Provera)
- Intrauterine Device
Who cannot join
- Lifetime history of DSM-IVopiod, alcohol, or other substance abuse.
- History of opioid treatment for RLS with inadequate response
- Positive urine toxicology screen at visit 1.
- Another chronic pain syndrome that would, in the opinion of the investigator, interfere with evaluation of RLS symptoms or the response to the study medication.
- Plan to undergo a procedure that may require short or long-term opiates for pain control during the course of the trial.
- History of severe mental illness.
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- Women who are pregnant, lactating, or planning to become pregnant.
- Shift work or other commitments that do not allow for regular sleep at night.
- Known hypersensitivity or intolerance to opioids.
- History of Long QT Syndrome or an immediate family member with this condition, or known prolongation of QTc interval.
- QTc interval prolongation >500 ms on screening EKG at Visit 1.
- History of malignant melanoma.
- Current use of monoamine oxidase inhibitors.
- Prior or current clinically significant impulse control disorder, as determined by clinical interview and the Modified Minnesota Impulse Disorders Interview at Visit 1.8
- Untreated severe sleep apnea, defined as AHI >30.
- Iron deficiency, defined as ferritin<15 at Visit 1.
- Any dermatologic condition resulting in widespread compromise of skin integrity, defined as >50% of the surface area within the 8 sites described for BTDS application.
- Current use of class IA or class III anti-arrhythmic medication.
- Significant risk for suicide by clinical interview.
- Known hypersensitivity to buprenorphine or any excipient of BTDS.
- Current unstable medical illness.
- Any medical or psychiatric condition that, in the opinion of the investigator, would interfere with participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment.
The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life.
Read more
The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts.
Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2.
Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period.
Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained.
Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.
- Conditions
- Restless Legs Syndrome
- Being tested
- buprenorphine transdermal delivery system (BTDS), Placebo for BTDS patch
- Keywords
- Restless Legs Syndrome, Willis Ekbom Disease, Twitchy Legs, Periodic Limb Movements, Leg Movements, Augmentation, Requip, ropinirole, Mirapex, pramipexole, gabapentin, Horizant, Neupro, rotigotine
- 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.
buprenorphine transdermal delivery system (BTDS)Drug
Also called Butrans
Placebo for BTDS patchDrug
A placebo patch will be manufactured to mimic the BTDS patch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Patch | Placebo comparator | The Placebo is in the form of a patch. We will be using placebo patches labeled 5mcg/hour, 10mcg/hour, and 20mcg/hour that will be changed every 7 days.
Each subject will participate in this arm of the study for four weeks. Receives: Drug: buprenorphine transdermal delivery system (BTDS); Drug: Placebo for BTDS patch |
| buprenorphine transdermal delivery system (BTDS) | Experimental | buprenorphine transdermal delivery system (BTDS), brand name Butrans. Butrans is in the form of a patch. We will be using 5mcg/hour, 10mcg/hour, and 20mcg/hour patches that will be changed every 7 days.
Each subject will participate in this arm of the study for four weeks. Receives: Drug: buprenorphine transdermal delivery system (BTDS); Drug: Placebo for BTDS patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Restless Legs Scale (IRLS)
The primary endpoint will be the within-subjects difference in IRLS between BTDS and placebo treatment, measured at visits 5 and 8. This comparison will be made with a fixed effects model in SAS, using PROC MIXED with a repeated statement (baseline, BTDS, placebo) to account for intra-subject correlation. Sequence, treatment, and treatment by sequence interactionterms will be included as fixed effects.
Measured: Within subjects IRLS score change after 4 weeks on placebo vs 4 weeks on BTDS
Secondary outcomes (1)
Clinical Global Impression of Improvement
The main secondary endpoint will be the difference between placebo and BTDS in the percentage of subjects who are "much improved" or "very much improved" on the CGI-I, evaluated using generalized estimating equations.
Measured: Evaluated after 4 weeks on placebo and again after 4 weeks on BTDS or vice versa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startApr 2014 (estimated)
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: No funding
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 Massachusetts General HospitalThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Winkelman, MD, PhD, Massachusetts General Hospital
- Investigators
- John W. Winkelman, MD, PhD, Principal investigator, Massachusetts General Hospital (Partners Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138357
- Sponsor's protocol ID
- 2013D004946
- Acronym
- Butrans
- Status last verified
- Oct 2023
- First submitted
- 9 May 2014
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butrans for Treatment of Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT02138357
- Acronym / sponsor ID
- Butrans / 2013D004946
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Willis Ekbom Disease, Twitchy Legs, Periodic Limb Movements, Leg Movements, Augmentation, Requip, ropinirole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2014 (estimated)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 May 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 primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment.
The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life.
The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts.
Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2.
Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period.
Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained.
Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Patch | Placebo comparator | Drug: buprenorphine transdermal delivery system (BTDS), Drug: Placebo for BTDS patchThe Placebo is in the form of a patch. We will be using placebo patches labeled 5mcg/hour, 10mcg/hour, and 20mcg/hour that will be changed every 7 days. Each subject will participate in this arm of the study for four weeks. |
| buprenorphine transdermal delivery system (BTDS) | Experimental | Drug: buprenorphine transdermal delivery system (BTDS), Drug: Placebo for BTDS patchbuprenorphine transdermal delivery system (BTDS), brand name Butrans. Butrans is in the form of a patch. We will be using 5mcg/hour, 10mcg/hour, and 20mcg/hour patches that will be changed every 7 days. Each subject will participate in this arm of the study for four weeks. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subject has a diagnosis of RLS, defined by International Restless Legs Study Group (IRLS) essential criteria:
- Subject has moderate to severe RLS symptoms,defined as an International Restless Legs Scale (IRLS) score greater than or equal to15 at the baseline visit (visit 2).
- Subject has RLS symptoms that, in the opinion of the investigator, require round-the-clock treatment.
- Subject speaks and reads English.
- Subject is able to provide informed consent.
Key exclusion criteria (22 listed)
- Lifetime history of DSM-IVopiod, alcohol, or other substance abuse.
- History of opioid treatment for RLS with inadequate response
- Positive urine toxicology screen at visit 1.
- Another chronic pain syndrome that would, in the opinion of the investigator, interfere with evaluation of RLS symptoms or the response to the study medication.
- Plan to undergo a procedure that may require short or long-term opiates for pain control during the course of the trial.
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 |
|---|---|---|
| buprenorphine transdermal delivery system (BTDS)Also: Butrans | Drug | Placebo Patch, buprenorphine transdermal delivery system (BTDS) |
| Placebo for BTDS patchA placebo patch will be manufactured to mimic the BTDS patch. | Drug | Placebo Patch, buprenorphine transdermal delivery system (BTDS) |
Primary outcome
The International Restless Legs Scale (IRLS)
Time frame: Within subjects IRLS score change after 4 weeks on placebo vs 4 weeks on BTDS
The primary endpoint will be the within-subjects difference in IRLS between BTDS and placebo treatment, measured at visits 5 and 8. This comparison will be made with a fixed effects model in SAS, using PROC MIXED with a repeated statement (baseline, BTDS, placebo) to account for intra-subject correlation. Sequence, treatment, and treatment by sequence interactionterms will be included as fixed effects.
1 secondary outcome
Clinical Global Impression of Improvement
Time frame: Evaluated after 4 weeks on placebo and again after 4 weeks on BTDS or vice versa
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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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.
John W. Winkelman, MD, PhD principal investigator
Massachusetts General Hospital (Partners Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing buprenorphine transdermal delivery system (BTDS) in people with Restless Legs Syndrome, run by Massachusetts General Hospital 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 22 inclusion and 22 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: withdrawn, as of the sponsor's last update on 25 Oct 2023. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 International Restless Legs Scale (IRLS) (time frame: Within subjects IRLS score change after 4 weeks on placebo vs 4 weeks on BTDS). 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 25 Oct 2023.