Table 1 Overview of 17 randomised, controlled trials with oral naratriptan for migraine treatment found in the GSK Trial Register (http://www.gsk-clinicalstudyregister.com/)
Drugs used [reference] (protocol code in GSK register) | Number of centers | Total number of patients (study design) | Full publication | Abstract(s) | Results |
|---|---|---|---|---|---|
Na 2.5 mg vs. naproxen sodium (NS) 275 mg [8] [S2WA4003] | 19 | 168 (P) | – | – | Na and NS had similar effect on MRQL |
Na 2.5 mg vs. NS 275 mg [9] [S2WA4004] | 20 | 171 (P) | – | – | Na and NS had similar effect on MRQL |
Na 2.5 mg vs. NS 500 mg [10] [S2W40010]a | 70 | 456 (C) | – | – | Preference: Na (34%) > NS (26%)c |
Na 2.5 mg vs. PL in mild MAM [11] [S2W40031] | 152 | 229 (P) | + | – | Na (58% headache relief) > PL (30% headache relief) |
Na 1 mg b.i.d. vs. placebo for MAM [12] [S2W40012] | 51 | 187 (P) | – | + | Without MAM: Na 38% > PL 29% |
Na 1 mg b.i.d. vs. PL [13] [S2W40024] | 61 | 236 (P) | – | + | Without MAM: Na 34% > PL 24% |
Na 0.1, 0.25, 1.0, 2.5 mg vs. PL [14] [S2WA3001] | 54 | 613 (P) | + | + | Na 1 mg (50%) and 2.5 mg (60%) > PL (34%) for headache relief at 4 h |
Na 0.25, 1.0, and 2.5 mg vs. PL [15] [S2WA3003] | 50 | 602 (C) | + | + | Na 1.0 mg (57%) and 2.5 mg (68%) > PL (33%) for headache relief after 4 h |
Na 0.25, 1.0, and 2.5 mg vs. placebo in adolescent migraine [16] [S2WA3012] | 44 | 300 (P) | – | + | Na 0.25 mg (72%), 1.0 mg (67%) and 2.5 mg (64%) were similar to PL (65%) for headache relief after 4 h |
Na 2.5 mg vs. PL in pt not responding to sumatriptan [17] [S2WA4002] | 57 | 206 (382) (P)b | + | + | Na (47%) > PL (20%) for headache relief after 4 h |
Na 2.5 mg b.i.d. vs. PL in transformed migraine [18] [S2WA4005] | 11 | 170 (P) | – | – | Na (13%) similar to PL (17%) for no headache on days 13 and 14. |
Na 1 mg and 2.5 mg b.i.d. vs. PL in MAM [19] [S2WA4006] | 18 | 206 (P) | + | + | Median MAM over 4 menstruation: PL = 4, 1 mg = 2, 2.5 mg = 3. Na 1.0 mg < PL (p = 0.011) |
Na 2.5 mg vs. sumatriptan 100 mg in recurrence prone patients [20] [S2WB3011] | 34 | 236 (C) | + | + | 24 h overall efficacy: Na (40%) similar to sumatriptan (35%) |
Na 0.1 mg, 0.25 mg, 1.0 mg, and 2.5 mg vs. sumatriptan 100 mg vs. placebo [21] [S2WB3002] | 113 | 1,141 (942) (P)c | − | + | Na 1.0 mg (52%) and 2.5 mg (66%) > PL (27%) for headache relief at 4 h, sumatriptan (76%) was superior to all Na doses |
Na 2.5 mg vs. sumatriptan 50 mg in patients who relapse from sumatriptan (100 mg orally or 6 mg subcutaneously) [22] [S2WB4001] | 66 | 464 (C) | – | – | Satisfaction with overall effectiveness: very satisfied or satisfied: Na (52%) similar to sumatriptan (48%) |
Na 5 mg and 10 mg vs. placebo [23] [S2WB2003] | 10 | 90 (P) | – | – | Headache relief at 4 h: Na 5 mg (89%) and 10 mg (72%) > PL (33%) |
Na 1, 2.5, 5, 7.5, and 10 mg vs. sumatriptan 100 mg and vs. PL [24] [S2WB2004] | 74 | 637 (P) | + | + | For headache relief at 4 h all doses of Na (64%, 63%, 65%, 80%, and 80%) were superior to PL (39%). Na 7.5 mg and 10 mg were similar to sumatriptan 100 mg (80%), which was superior to Na 1, 2.5, and 5 mg |