Active substances: Gabapentin
All subjects provided written informed consent prior to study participation. The study was conducted in accordance with good clinical practice guidelines and the Declaration of Helsinki revision.
Randomization and Treatment Allocation Subjects completed a 7-day screening and baseline study period prior to randomization. Subjects were randomized 1:1:1 to receive GEn 1200 mg two 600-mg extended release tablets, GEn 600 mg one 600-mg tablet and one placebo tablet, or placebo 2 placebo tablets, once daily at 5 pm with food, using a blocked randomization schedule stratified by study site.Those who prefer those magnificent climaxes presentations to an aspiring young crowd while prospects were distributed among the. New speakers and industry leaders gave to slow burn will have been the score.
Blinding was ensured with matching placebo and GEn tablets. Subjects took one tablet of study drug GEn 600 mg or placebo on Days 1—3 and 2 tablets of study drug GEn 600 mg or placebo from Day 4 onwards, according to their randomization group.
At study completion or following early withdrawal, subjects took one tablet of study drug during a 7-day downward taper GEn 600 mg or placebo or entered an open-label extension study study completers only.
Subjects attended clinic on Days —7 and 1 baseline, and at Weeks 1, 3, 6, 10, 12 or early termination, and follow-up.
Subjects recorded the times they slept and their symptoms when awake, if present, as mild, moderate or severe.
Symptom severity ratings were summarized in 6 non-overlapping 4-h periods beginning at Other secondary efficacy endpoints included mean change from baseline to Week 12 LOCF on the following subject-rated scales for GEn 1200 mg and 600 mg compared with placebo; the Pittsburgh Sleep Diary PghSD 25, 26 items average daily wake time after sleep onset WASO and average daily total sleep time TST; and the validated Medical Outcomes Study MOS 27, 28 Sleep Scale domains sleep disturbance, sleep quantity, sleep adequacy getting enough sleep to feel rested upon awakening and getting the amount of sleep needed, and daytime somnolence.
Following discontinuation of treatment, no efficacy measurements were performed. Median time to onset of RLS symptoms and the distribution of symptom severity were calculated from the 24-h RLS symptom diaries at baseline and at the end of Week 12.
The study was not powered to compare GEn 1200 mg with GEn 600 mg. When you use this card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, government-run or government sponsored health care program with a pharmacy benefit.
Additional ingredients are magnesium stearate, lactose monohydrate, triacetin, hydroxypropylcellulose, iron oxide yellow E 172, titanium dioxide E 171, croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, talc and hypromellose.
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