Pharmacokinetics of two 6-day frovatriptan dosing regimens used for the short-term prevention of menstrual migraine: A phase i, randomized, double-blind, placebo-controlled, two-period crossover, single-centre study in healthy female volunteers

Clinical Drug Investigation

Volumn 29, Issue 5, 2009, Pages 325-337

  Wade, Andrew ^a   Pawsey, Stephen ^a,c   Whale, Holly ^a   Boyce, Malcolm ^b   Warrington, Steve ^b  

^a Vernalis Development Ltd   (United Kingdom)

^b Hammersmith Medicines Research Limited and Trio Medicines Limited   (United Kingdom)

^c Vernalis PLC   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CONTRACEPTIVE AGENT; ESTROGEN; FROVATRIPTAN; PLACEBO;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG TOLERABILITY; EVENING DOSAGE; FEMALE; HEADACHE; HUMAN; LIQUID CHROMATOGRAPHY; MENSTRUAL CYCLE; MENSTRUAL MIGRAINE; MORNING DOSAGE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TANDEM MASS SPECTROMETRY; TREATMENT DURATION; VOLUNTEER; VOMITING;

ADULT; AREA UNDER CURVE; CARBAZOLES; CHROMATOGRAPHY, LIQUID; CONTRACEPTIVE AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ESTROGENS; FEMALE; HUMANS; INCIDENCE; MENSTRUATION; MIGRAINE DISORDERS; SEROTONIN AGONISTS; SEVERITY OF ILLNESS INDEX; TANDEM MASS SPECTROMETRY; TRYPTAMINES; YOUNG ADULT;

EID: 65249187759     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200929050-00005     Document Type: Article

References (29)

1. Dzoljic E, Sipetic S, Vlajinac H, et al. Prevalence of men-strually related migraine and nonmigraine primary headache in female students of Belgrade University. Headache 2002 Mar; 42 (3): 185-93
2. Granella F, Sances G, Allais G, et al. Characteristics of menstrual and nonmenstrual attacks in women with menstrually related migraine referred to headache centres. Cephalalgia 2004 Sep; 24 (9): 707-16
3. Couturier EG, Bomhof MA, Neven AK, et al. Menstrual migraine in a representative Dutch population sample: prevalence, disability and treatment. Cephalalgia 2003 May; 23 (4): 302-8
4. Diener HC, Ryan R, Sun W, et al. The 40-mg dose of eletriptan: comparative efficacy and tolerability versus sumatriptan 100 mg. Eur J Neurol 2004 Feb; 11 (2): 125-34
5. Nett R, Landy S, Shackelford S, et al. Pain-free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine. Obstet Gynecol 2003 Oct; 102 (4): 835-42
6. Allais G, Acuto G, Cabarrocas X, et al. Efficacy and toler-ability of almotriptan versus zolmitriptan for the acute treatment of menstrual migraine. Neurol Sci 2006 May; 27 Suppl. 2: S193-7
7. Silberstein SD, Elkind AH, Schreiber C, et al. A randomized trial of frovatriptan for the intermittent prevention of menstrual migraine. Neurology 2004 Jul 27; 63 (2): 261-9
8. Mannix LK, Files JA. The use of triptans in the management of menstrual migraine. CNS Drugs 2005; 19 (11): 951-72
9. Moschiano F, Allais G, Grazzi L, et al. Naratriptan in the short-term prophylaxis of pure menstrual migraine. Neurol Sci 2005; 26 Suppl. 2: S162-6
10. Newman L, Mannix LK, Landy S, et al. Naratriptan as short-term prophylaxis of menstrually associated migraine: a randomized, double-blind, placebo-controlled study. Headache 2001 Mar; 41 (3): 248-56
11. Newman LC, Lipton RB, Lay CL, et al. A pilot study of oral sumatriptan as intermittent prophylaxis of menstruation-related migraine. Neurology 1998; 51 (1): 307-9
12. Buchan P, Keywood C, Wade A, et al. Clinical pharmacokinetics of frovatriptan. Headache 2002 Apr; 42 Suppl. 2: S54-62
13. Rapoport A, Ryan R, Goldstein J, et al. Dose range-finding studies with frovatriptan in the acute treatment of migraine. Headache 2002 Apr; 42 Suppl. 2: S74-83
14. Wade A, Warrington S, Whale H, et al. Pharmacokinetics and tolerability in healthy subjects of 6-day frovatriptan dosing regimen used for the short-term prevention of menstrual migraine. Headache 2006; 46 (5): 844
15. MacGregor EA, Frith A, Ellis J, et al. Incidence of migraine relative to menstrual cycle phases of rising and falling estrogen. Neurology 2006 Dec 26; 67 (12): 2154-8
16. Lee AJ, Cai MX, Thomas PE, et al. Characterization of the oxidative metabolites of 17beta-estradiol and estrone formed by 15 selectively expressed human cytochrome p450 isoforms. Endocrinology 2003 Aug; 144 (8): 3382-98
17. Frova® tablets. Frovatriptan succinate. Chadds Ford (PA): Endo Pharmaceuticals Inc., 2007
18. Koch G. The use of nonparametric methods in the statistical analysis of the two-period change-over design. Biometrics 1972; 28: 277-84
19. Hodges Jr JL, Lehmann EL. Estimates of location based on rank tests. Ann Math Stat 1963; 34: 598-611
20. Granfors MT, Backman JT, Laitila J, et al. Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2. Clin Pharmacol Ther 2005 Oct; 78 (4): 400-11
21. Campbell J, MacGregor A, Pawsey S, et al. Short-term frovatriptan for prevention of menstrual migraine: safety and efficacy over 12-15 months. Cephalalgia 2007; 27 (6): 753
22. Brandes JL, MacGregor A, Silberstein S, et al. Prevention of difficult-to-treat menstrual migraine using a 6-day regimen of frovatriptan: a second double-blind, randomized, placebo-controlled trial. Headache 2007; 47 (5): 789-90
23. Shelepova T, Nafziger AN, Victory J, et al. Effect of a triphasic oral contraceptive on drug-metabolizing enzyme activity as measured by the validated Cooper-stown 5+1 cocktail. J Clin Pharmacol 2005 Dec; 45 (12): 1413-21
24. Zomig®, Zomig-ZMT® tablets and orally disintegrating tablets: zolmitriptan. Wilmington (DE): AstraZeneca, 2005
25. Amerge® tablets: naratriptan hydrochloride. Research Triangle Park (NC): GlaxoSmithKline, 2006
26. Geraud G, Spierings EL, Keywood C. Tolerability and safety of frovatriptan with short- and long-term use for treatment of migraine and in comparison with sumatriptan. Headache 2002 Apr; 42 Suppl. 2: S93-9
27. Lipton RB, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache 2001 Jul-Aug; 41 (7): 646-57
28. Leonardi M, Steiner TJ, Scher AT, et al. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J Headache Pain 2005 Dec; 6 (6): 429-40
29. Steiner TJ, Scher AI, Stewart WF, et al. The prevalence and disability burden of adult migraine in England and their relationships to age, gender and ethnicity. Cephalalgia 2003 Sep; 23 (7): 519-27