Restless Legs SyndromePhase 2/3NCT00621517
Bupropion and Restless Legs Syndrome
A Phase 2/3 study testing Bupropion in people with Restless Legs Syndrome, run by East Tennessee State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2009
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Restless Legs Syndrome
- Severity Scale score 15 or higher
Who cannot join
- History of seizures
- History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
- Suicidal thoughts/ideations
- Inability to return for follow up appointments at 3 and 6 weeks
- Lack of access to telephone
- Eating disorder
Show all 9Show fewer
- Age less than 18
- Pregnancy
- Unwillingness or inability to discontinue any RLS medications
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
Read the detailed description
Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.
- Conditions
- Restless Legs Syndrome
- Being tested
- Bupropion, Placebo
- Keywords
- Restless Legs Syndrome, Bupropion
- 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.
BupropionDrug
Also called Wellbutrin
Partipants will receive 150 mg bupropion per night
PlaceboDrug
1 capsule nightly for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive 150MG Bupropion nightly. Receives: Drug: Bupropion |
| 2 | Placebo comparator | Participants will receive matching placebo capsule nightly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.
Measured: Baseline, three weeks, and six weeks
Clinical Global Impression - Improvement Scale
Measured: three weeks and six weeks
Ordinal Scale (i.e., 1-8) of Symptom Severity
Measured: three weeks and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bayard, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621517
- Sponsor's protocol ID
- ETSU-07-061f
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2008
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion and Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00621517
- Acronym / sponsor ID
- ETSU-07-061f
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Bupropion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 5 Apr 2012
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 determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
Detailed description
Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.
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 |
|---|---|---|
| 1 | Experimental | Drug: BupropionParticipants will receive 150MG Bupropion nightly. |
| 2 | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo capsule nightly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Restless Legs Syndrome
- Severity Scale score 15 or higher
Key exclusion criteria (9 listed)
- History of seizures
- History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
- Suicidal thoughts/ideations
- Inability to return for follow up appointments at 3 and 6 weeks
- Lack of access to telephone
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 |
|---|---|---|
| BupropionAlso: WellbutrinPartipants will receive 150 mg bupropion per night | Drug | 1 |
| Placebo1 capsule nightly for six weeks | Drug | 2 |
Primary outcome
Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
Time frame: Baseline, three weeks, and six weeks
Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.
Clinical Global Impression - Improvement Scale
Time frame: three weeks and six weeks
Ordinal Scale (i.e., 1-8) of Symptom Severity
Time frame: three weeks and six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupropion in people with Restless Legs Syndrome, run by East Tennessee State 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 2 inclusion and 9 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 6 Mar 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Apr 2012). 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 in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. (time frame: Baseline, three weeks, and six weeks). The study lists 3 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 6 Mar 2019.