Restless Leg SyndromePhase 4NCT02117076
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
A Phase 4 study testing Gabapentin immediate release and Gabapentin enacarbil extended release in people with Restless Leg Syndrome, run by Theresa Zesiewicz, MD at 1 site in United States.
Trial summary
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Restless Leg Syndrome
- What is being tested?
- Gabapentin immediate release and Gabapentin enacarbil extended release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria8.
- RLS symptoms ≥ 15 nights of the month prior to study enrollment and for ≥ 4 of 7 consecutive nights in the week prior to study enrollment (if untreated).
- Age 18 years to 80 years.
- International Restless Legs Scale (IRLS) Total severity score of ≥ 15 (moderate to severe severity). 8
- Had significant sleep disturbance on item 4 of IRLS.8
- Women of child-bearing potential must use a reliable method of contraception.
- Informed consent. Subject must be willing and able to complete all study procedures.
Who cannot join
- Any illness that in the investigator's opinion preclude participation in this study.
- Subjects with non-RLS-related sleep disorders (e.g., sleep apnea)
- Subjects with neurological diseases or movement disorders other than RLS (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias)
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini-Mental State Examination scores less than 27).
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- Legal incapacity or limited legal capacity.
- History of RLS symptom augmentation or early-morning rebound with previous dopamine-agonist treatment.
- Clinically significant abnormalities in renal function. 3,8,10
- Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
- Concomitant treatment with drugs known to affect sleep/wake, RLS or periodic limb movements, including antidepressants. Subjects receiving treatment for RLS at screening will be required to discontinue and wash out for a minimum of 5 half-lives.
- Body mass index greater than 34 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.
Read the detailed description
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Subjects will be randomized to gabapentin (IR) or Horizant™ (ER). Dosing will be blinded to both patient and study team members. Once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.
- Conditions
- Restless Leg Syndrome
- Being tested
- Gabapentin immediate release, Gabapentin enacarbil extended release
- Keywords
- Restless leg syndrome, RLS, gabapentin, gabapentin enacarbil, Neurontin, Horizant
- 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.
Gabapentin immediate releaseDrug
Also called Neurontin
up to 1200 mg per day
Gabapentin enacarbil extended releaseDrug
Also called Horizant
up to 1200 mg per day
| Study group | Role | What they receive |
|---|---|---|
| gabapentin immediate release | Active comparator | Gabapentin IR is the immediate release form of the medication. Subjects randomized to gabapentin IR will be started out at a dose of 300mg per day, taken one hour before bedtime for the first week. Daily dose will be increased by 300 mg daily every 4 days until 1200 mg of gabapentin IR is reached or until a stable, tolerated dose of gabapentin IR that relieves symptoms has been maintained for 2 weeks (IRLS scores less than 15). Those patients who cannot tolerate gabapentin IR will be allowed to down titrate by one dose level (300 mg daily), before dropping out of the study. Receives: Drug: Gabapentin immediate release |
| gabapentin enacarbil extended release | Active comparator | Horizant is the extended release form of gabapentin enacarbil. Subjects randomized to Horizant will take 600mg at 5 pm. After four days of stable dosing of Horizant, subjects in this study group will be evaluated by phone for changes in RLS symptoms and Patient Global Impression scale to determine if a dose increase is warranted. Subjects in this group may be titrated up to 1200 mg daily during the 2 week titration period. Receives: Drug: Gabapentin enacarbil extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Leg Syndrome Rating Scale (IRLS)
The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens.
from 0 to 4.
Measured: 10 weeks
Secondary outcomes (1)
Restless Leg Syndrome Quality of Life Scale (RLSQoL)
The Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) assesses the impact of RLS on daily life, emotional well-being, social life, and work life.
Measured: Baseline, day 35, day 54.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresa Zesiewicz, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theresa Zesiewicz, MD, University of South Florida
- Investigators
- Theresa Zesiewicz, MD, FAAN, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117076
- Sponsor's protocol ID
- RLS and Gabapentin or Horizant
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2014
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT02117076
- Acronym / sponsor ID
- RLS and Gabapentin or Horizant
- Conditions
- Restless Leg Syndrome
- Keywords
- Restless leg syndrome, RLS, gabapentin, gabapentin enacarbil, Neurontin, Horizant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Theresa Zesiewicz, MDUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Apr 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 study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.
Detailed description
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Subjects will be randomized to gabapentin (IR) or Horizant™ (ER). Dosing will be blinded to both patient and study team members. Once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.
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 |
|---|---|---|
| gabapentin immediate release | Active comparator | Drug: Gabapentin immediate releaseGabapentin IR is the immediate release form of the medication. Subjects randomized to gabapentin IR will be started out at a dose of 300mg per day, taken one hour before bedtime for the first week. Daily dose will be increased by 300 mg daily every 4 days until 1200 mg of gabapentin IR is reached or until a stable, tolerated dose of gabapentin IR that relieves symptoms has been maintained for 2 weeks (IRLS scores less than 15). Those patients who cannot tolerate gabapentin IR will be allowed to down titrate by one dose level (300 mg daily), before dropping out of the study. |
| gabapentin enacarbil extended release | Active comparator | Drug: Gabapentin enacarbil extended releaseHorizant is the extended release form of gabapentin enacarbil. Subjects randomized to Horizant will take 600mg at 5 pm. After four days of stable dosing of Horizant, subjects in this study group will be evaluated by phone for changes in RLS symptoms and Patient Global Impression scale to determine if a dose increase is warranted. Subjects in this group may be titrated up to 1200 mg daily during the 2 week titration period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria8.
- RLS symptoms ≥ 15 nights of the month prior to study enrollment and for ≥ 4 of 7 consecutive nights in the week prior to study enrollment (if untreated).
- Age 18 years to 80 years.
- International Restless Legs Scale (IRLS) Total severity score of ≥ 15 (moderate to severe severity). 8
- Had significant sleep disturbance on item 4 of IRLS.8
Key exclusion criteria (12 listed)
- Any illness that in the investigator's opinion preclude participation in this study.
- Subjects with non-RLS-related sleep disorders (e.g., sleep apnea)
- Subjects with neurological diseases or movement disorders other than RLS (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias)
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
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 |
|---|---|---|
| Gabapentin immediate releaseAlso: Neurontinup to 1200 mg per day | Drug | gabapentin immediate release |
| Gabapentin enacarbil extended releaseAlso: Horizantup to 1200 mg per day | Drug | gabapentin enacarbil extended release |
Primary outcome
International Restless Leg Syndrome Rating Scale (IRLS)
Time frame: 10 weeks
The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens. from 0 to 4.
1 secondary outcome
Restless Leg Syndrome Quality of Life Scale (RLSQoL)
Time frame: Baseline, day 35, day 54.
Results and safety
The study was stopped early (reason given: Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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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.
Theresa Zesiewicz, MD, FAAN principal investigator
University of South Florida
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 Gabapentin immediate release and Gabapentin enacarbil extended release in people with Restless Leg Syndrome, run by Theresa Zesiewicz, MD 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 16 Nov 2021. 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.
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 stopped early (reason given: Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.). Results are not available in the source record.
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?
International Restless Leg Syndrome Rating Scale (IRLS) (time frame: 10 weeks). 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 16 Nov 2021.