Randomized, double-blind, placebo-controlled, phase II trial of gabapentin enacarbil for migraine prophylaxis. Gabapentin in the prophylaxis of migraine: a double-blind randomized placebo-controlled study. [Effectiveness and safety of gabapentin in the preventive treatment of migraine].
The objective of this article is to evaluate the efficacy and safety of gabapentin enacarbil (GEn) for migraine prophylaxis.
                In this randomized, double-blind, parallel-group study, patients with International Headache Society-defined migraine who met criteria suggesting the need for prophylactic therapy were randomized 2:1:2:2:1 to one of the following five groups, designated according to target daily dose of study medication during the 20-week treatment period: placebo, GEn 1200 mg, GEn 1800 mg, GEn 2400 mg, or GEn 3000 mg.
                The intent-to-treat population included 523 patients (n = 128 placebo, n = 66 GEn 1200 mg, n = 134 GEn 1800 mg, n = 133 GEn 2400 mg, n = 62 GEn 3000 mg). No statistically significant difference between active treatment (the average of 1800 mg and 2400 mg treatment groups) and placebo was found for change from baseline in the number of migraine headache days during the last four weeks of treatment prior to taper (the primary endpoint). Results of analyses of the primary endpoint using the per protocol population, analyses using imputation methods different from those of the primary analysis, and nonparametric analyses were consistent with the primary analysis in showing no difference between active treatment and placebo. The pattern of results was similar for the secondary efficacy endpoints. Pharmacokinetic data demonstrate that patients had adequate estimated exposure to GEn. The adverse event profile of GEn was consistent with that in previous studies.
                GEn did not significantly differ from placebo for migraine headache prophylaxis. A high placebo effect should be considered when interpreting these results. Gabapentin is an antiepileptic drug of new generation that increases brain GABA levels. We report the results of a three-month randomised double-blind placebo-controlled study on the effects of gabapentin in the prophylaxis of patients with migraine meeting the IHS criteria.
                We treated 63 patients suffering from migraine with or without aura. Patients treated their attack at home using symptomatic drugs and clinical assessment was recorded on a diary. After a washout of 8 week from any other prophylactic treatment, all patients were treated with 1200 mg/day of gabapentin; this is our therapeutic plan: 400 mg/day from 1st to 3rd day, 800 mg/day from 4th to 6th day and 1200 mg/day from 7th day.
                No patients withdrew, gabapentin was well tolerated; adverse events (somnolence, dizziness, tremor, fatigue and ataxia) generally were transient and mild to moderate in severity and in 13 patients (27%) only occurred. At the end of treatment, in such case, we reported a significative reduction of frequency and intensity of migraine in 30 patients treated with gabapentin.
                Our observations indicate that gabapentin is well tolerated by patients and that reduces headache frequency and use of symptomatic drugs in both groups. Gabapentin shows to have an effective therapeutic action in the prophylactic treatment of migraine. Migraine is a frequent and disabling pathological condition with important socioeconomic repercussions. Recent studies have explored the use of antiepileptic drugs in the prophylactic treatment of migraine. Preliminary studies have shown that gabapentin is a drug that is effective and well tolerated by patients. AIM. To evaluate the effectiveness and safety of gabapentin in the prophylactic treatment of migraine.
                A prospective, open, multicentre, random clinical study, carried out according to IHS criteria, which compares the effectiveness and safety of gabapentin in 1,200 mg/day and 2,000 mg/day doses as a preventive treatment for migraine over a 16 week period.
                Significant differences were found in patients treated with gabapentin, as compared with their basal state, in the following: a lower number of attacks (reduction in weeks 4, 10 and 16: 2.4 2.8, 2.9 2.9 and 3.1 2.9 attacks/month on a basal rate of 5.3 3.5 attacks/month), lower intensity (on a scale of 0 3 of increasing pain intensity: basal rate: 2.7 0.4, week 4: 1.8 0.9, week 10: 1.7 0.9, week 16: 1.4 1.0) and how long the pain lasts (basal rate 390 hours/month, week 4: 180 hours/month, week 10: 180 hours/month, week 16: 120 hours/month). No statistically significant differences were found between doses of 1,200 or 2,000 mg/day. Mild adverse effects were seen in 62 patients (37.8%): drowsiness (22.6%), asthenia (7.9%), dizziness (4.9%), abdominal pain (3.7%) and dazedness (3.7%). No serious adverse events occurred.
                Gabapentin can be considered an effective and safe drug in the preventive treatment of migraine.
The pooled evidence derived from trials of gabapentin suggests that it is not efficacious for the prophylaxis of episodic migraine in adults. Since adverse events were common among the gabapentin-treated patients, it is advocated that gabapentin should not be used in routine clinical practice. Gabapentin enacarbil is not efficacious for the prophylaxis of episodic migraine in adults. There is no published evidence from controlled trials of pregabalin for the prophylaxis of episodic migraine in adults.