Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome
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|ClinicalTrials.gov Identifier: NCT02424695|
Recruitment Status : Unknown
Verified April 2015 by Mansoor Ahmed M.D., Cleveland Sleep Research Center.
Recruitment status was: Not yet recruiting
First Posted : April 23, 2015
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Drug: Gabapentin Enacarbil (GEn) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effects of Gabapentin Enacarbil on Intensity of Cortical Arousal, Heart Rate, Blood Pressure and Anterior Tibialis EMG Responses Associated With PLMs During Sleep in Patients With RLS Using a Novel Computer Assisted Scoring System|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Single Gabapentin Enacarbil Arm
Gabapentin Enacarbil (Gen) 600 mg will be administered once daily for 4 weeks
Matching placebo will be administered once daily for one week prior initiation of treatment with GEn
Drug: Gabapentin Enacarbil (GEn)
HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with "GS LFG", supplied as:
600 mg: NDC 53451-0101-1.The drug will be stored at 25°C (77°F) (excursions permitted 15° to 30°C (59° to 86°F)) Matching placebo will be provided by Xenoport Inc.
Other Name: HORIZANT
- The mean change from baseline to week 4 in intensity of cortical arousals associated with periodic limb movements (PLMs) [ Time Frame: 4 weeks ]Cortical EEG arousals will be scored using wavelet analysis of C3/A2 and C4/A1 EEG signals. Arousals scored in NREM sleep will be assigned a score from 0-9. This arousal scaling is entirely subjective. Wavelet analysis will be performed on each of the scaled arousals using wavelet features that correlate with arousal intensity. The arousal intensity will be measured using Wavelet Transform which is superior for analyzing signals such as EEG.
- The mean change from baseline to week 4 in heart rate variability associated with arousals secondary to periodic limb movements (PLMs) [ Time Frame: 4 weeks ]Beat to beat heart rate measurement will identify the highest value in the interval 2-12 seconds preceding each arousal which will be used as a baseline heart rate. The highest heart rate in the interval between arousal and at 8 seconds after its end, and the difference from baseline will represent the change in heart rate associated with the arousal.
- The mean change from baseline to week 4 in blood pressure associated with arousals secondary to periodic limb movements (PLMs) [ Time Frame: 4 weeks ]Blood pressure changes will be identified using the same technique as the heart rate changes. Continuous blood pressure will be monitored using Somnotouch RESP. Using the 2-12 seconds preceding each arousal, any identified change between onset of arousal and at 8 seconds after its end will represent the change in blood pressure.
- The mean change from baseline to week 4 in periodic limb movement (PLM) intensity [ Time Frame: 4 weeks ]Periodic limb movement (PLM) intensity will be derived by measuring the highest anterior tibialis EMG amplitude during the 2-12 seconds prior to arousal onset and comparing to maximum EMG amplitude during PLMs with or without associated arousal.
- The mean change from Baseline to week 4 in Rechtschaffen and Kales polysomnography parameters [ Time Frame: 4 weeks ]Polysomnography (PSG) studies will be recorded for 8 hours using standard techniques described by Rechtschaffen and Kales (R&K). The R&K standard PSG parameters include: Total sleep time (TST), wake after sleep onset (WASO), latency to persistent sleep (LPS 10), sleep efficiency (SE), number of awakenings per hour of sleep (Awakenings Index), arousals index (AI), sleep stage percentages, periodic limb movements per hour (PLMI), and periodic limb movements associated with arousal per hour (PLMAI).
- The mean change from baseline to week 4 in International Restless Legs Syndrome (IRLS) Rating Scale total score [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in proportion of responders ("much"/ "very much" improved) on the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in proportion of responders ("moderately better" to "a great deal better") on the patient Global Impression of Change (PGIC) scale [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in Post Sleep Questionnaire (PSQ)scores [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in Subjective Sleep Questionnaire (SSQ) scores [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL) scores [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in Restless Legs Syndrome- Next Day Impact Questionnaire (RLS-NDI) scores [ Time Frame: 4 weeks ]
- The mean change from Baseline to week 4 in the Epworth Sleepiness Scale (ESS) scores [ Time Frame: 4 weeks ]
- Number of subjects with treatment emergent adverse events [ Time Frame: 4 weeks ]
- Number of subjects with mild, moderate and severe adverse events [ Time Frame: 4 weeks ]
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): NCT02424695
|Contact: Rozina Aamir, MS, MBAfirstname.lastname@example.org|
|Contact: Zahra A Jishi, MPHemail@example.com|
|United States, Ohio|
|Cleveland Sleep Research Center|
|Middleburg Heights, Ohio, United States, 44130|
|Principal Investigator:||Mansoor Ahmed, MD||Cleveland Sleep Research Center|