Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
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|ClinicalTrials.gov Identifier: NCT02117076|
Recruitment Status : Terminated (Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.)
First Posted : April 17, 2014
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Restless Leg Syndrome||Drug: Gabapentin immediate release Drug: Gabapentin enacarbil extended release||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: gabapentin immediate release
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.
Drug: Gabapentin immediate release
up to 1200 mg per day
Other Name: Neurontin
Active Comparator: gabapentin enacarbil extended release
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.
Drug: Gabapentin enacarbil extended release
up to 1200 mg per day
Other Name: Horizant
- 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.
- Restless Leg Syndrome Quality of Life Scale (RLSQoL) [ Time Frame: Baseline, day 35, day 54. ]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.
- Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: Baseline, day 35, day 54 ]The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117076
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Theresa Zesiewicz, MD, FAAN||University of South Florida|