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Biomedical subjects

Alexander Mauskop

Publications and source records attributed to Alexander Mauskop.

10 recordsLinked to original sources
PubMed2006

Efficacy of Rizatriptan 10 mg administered early in a migraine attack.

OBJECTIVE: To determine if administration of rizatriptan 10 mg is superior to placebo for the early treatment of acute migraine, while the pain is mild. BACKGROUND: Past studies have suggested that treatment outcomes can be improved if a triptan is administered early in the time course of a migraine attack. METHODS: Two randomized, parallel, placebo-controlled, double-blind studies. TAME (Treat A Migraine Early)1 was conducted at 46 centers in the United States; TAME2, at 48 centers in the United States. Totally, 1030 adult patients with at least a 6-month history of migraine were studied. Patients were instructed to treat within 1 hour of migraine onset, while pain was mild. Patients maintained a headache diary in which they rated their levels of pain and disability, and recorded other symptoms of migraine. Primary endpoints were pain freedom at 2 hours and sustained pain freedom at 24 hours post-dose. RESULTS: In TAME1, 57.3% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 42.6% versus 23.2% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). In TAME2, 58.9% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 48.0% versus 24.6% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). All other efficacy endpoints favored rizatriptan. Repeat doses of the medicine were not allowed; patients may have delayed treatment; non-migraine headaches may have been treated. CONCLUSIONS: Rizatriptan 10 mg was superior to placebo when treating migraine early, while pain is mild, as measured by pain freedom at 2 hours and 24-hour sustained pain freedom.

Acute Disease↗
PubMed2006

Treatment of headaches with botulinum toxin.

Primary headache disorders, such as migraine, chronic daily headache (CDH), and chronic tension-type headache (CTTH), are some of the most frequent disorders encountered by physicians in the outpatient setting. Chronic headache disorders cause significant morbidity and functional impairment. Despite important advances in both pharmacological and behavioral management of headache disorders, a number of patients remain treatment resistant. Botulinum toxin (BT) is emerging as a new therapeutic alternative in the preventative treatment of headaches. BT has several advantages over current prophylactic strategies, such as reduced side-effect profile and improved patient compliance. Furthermore, there have been several studies supporting the safety and tolerability of BT in the treatment of headache disorders. Although additional large-scale studies are needed to clarify clinical predictors of response as well as optimal dosing, injection sites and mechanism of action, BT has demonstrated efficacy in the treatment of migraines and CDH. The evidence for the treatment for CTTH is less compelling.

Botulinum Toxins↗
PubMed2005

Botulinum toxin type a for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study.

OBJECTIVE: To assess the efficacy and safety of botulinum toxin type A (BoNT-A; BOTOX, Allergan, Inc., Irvine, CA) for the prophylaxis of headaches in patients with chronic daily headache (CDH) without the confounding factor of concurrent prophylactic medications. BACKGROUND: Several open-label studies and an 11-month, randomized, double-blind, placebo-controlled study suggest that BoNT-A may be an effective therapy for the prophylaxis of headaches in patients with CDH. DESIGN AND METHODS: This was a subgroup analysis of an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of adult patients with 16 or more headache days per 30-day periods conducted at 13 North American study centers. All patients had a history of migraine or probable migraine. This analysis involved data for patients who were not receiving concomitant prophylactic headache medication and who constituted 64% of the full study population. Following a 30-day screening period and a 30-day single-blind, placebo injection, eligible patients were injected with BoNT-A or placebo and assessed every 30 days for 9 months The following efficacy measures were analyzed per 30-day periods: change from baseline in number of headache-free days; change from baseline in headache frequency; proportion of patients with at least 30% or at least 50% decrease from baseline in headache frequency; and change from baseline in mean headache severity. Acute medication use was assessed, and adverse events were recorded at each study visit. RESULTS: Of the 355 patients randomized in the study, 228 (64%) were not taking prophylactic medication and were included in this analysis (117 received BoNT-A, 111 received placebo injections). Mean age was 42.4+/-10.90 years; the mean frequency of headaches per 30 days at baseline was 14.1 for the BoNT-A group and 12.9 for the placebo group (P=.205). After two injection sessions, the maximum change in the mean frequency of headaches per 30 days was -7.8 in the BoNT-A group compared with only -4.5 in the placebo group (P=.032), a statistically significant between-group difference of 3.3 headaches. The between-group difference favoring BoNT-A treatment continued to improve to 4.2 headaches after a third injection session (P=.023). In addition, BoNT-A treatment at least halved the frequency of baseline headaches in over 50% of patients after three injection sessions compared to baseline. Statistically significant differences between BoNT-A and placebo were evident for the change from baseline in headache frequency and headache severity for most time points from day 180 through day 270. Only 5 patients (4 patients receiving BoNT-A treatment; 1 patient receiving placebo) discontinued the study due to adverse events and most treatment-related events were transient and mild to moderate in severity. CONCLUSIONS: BoNT-A is an effective and well-tolerated prophylactic treatment in migraine patients with CDH who are not using other prophylactic medications.

Adult↗
PubMed2004

The use of botulinum toxin in the treatment of headaches.

Migraine is a disabling condition which affects 28 million Americans. Over 10 million Americans suffer from daily headaches. The discovery of triptans has revolutionized abortive therapy of migraines. However, patients suffering from frequent attacks and those who do not respond or do not tolerate triptans require prophylactic therapy. Many non-pharmacological treatments, such as biofeedback, magnesium and CoQ10 can be effective for some patients. Prophylactic pharmacotherapy of migraine headaches is limited in its efficacy and has a potential for systemic side effects. The use of botulinum toxin for movement disorders and cosmesis led to an accidental discovery of its beneficial effect on headaches. Extensive anecdotal evidence accumulated over the past seven years and controlled trials suggest that intermittent and chronic migraines as well as chronic tension-type headaches may respond to botulinum toxin injections. The effect of a single treatment, which is technically simple to administer, usually lasts three months. Botulinum toxin does not cause systemic or any other serious side effects. Many patients prefer botulinum toxin injections over prophylactic drugs because of its apparently high efficacy and remarkable safety. Several large controlled trials currently underway should lead to a wider acceptance of this treatment by neurologists and pain specialists.

Journal Article↗
PubMed2002

The use of botulinum toxin in the treatment of headaches.

The use of botulinum toxin for movement disorders and cosmesis led to an accidental discovery of its beneficial effect on headaches. Extensive anecdotal evidence and several controlled trials suggest that intermittent and chronic migraines and chronic tension headaches may respond to this treatment. The effect of a single treatment, which is simple to administer, can last for 3 months. Botulinum toxin does not cause systemic or any other serious side effects. Prophylactic pharmacotherapy of migraine headaches is limited in its efficacy and has a potential for systemic side effects. This makes botulinum toxin a preferred treatment for many patients. The large controlled trials that are underway may lead to a wider acceptance of this treatment by neurologists and pain specialists.

Botulinum Toxins, Type A↗
PubMed2002

Serum ionized magnesium levels and serum ionized calcium/ionized magnesium ratios in women with menstrual migraine.

OBJECTIVE: It has been suggested that magnesium deficiency may play an important role in menstrual migraine and that the serum ionized calcium (ICa2+)/ionized magnesium (IMg2+) ratio is important in migraine headache. Studies were designed to test these hypotheses. DESIGN: We prospectively evaluated 270 women seen at a headache clinic and in 61 women with menstrual migraine measured IMg2+, total magnesium, and ICa2+ levels so as to calculate the ICa2+/IMg2+ ratio. RESULTS: The incidences of IMg2+ deficiency were 45% during menstrual attacks, 15% during nonmenstrual attacks, 14% during menstruation without a migraine, and 15% between menstruations and between migraine attacks. The serum ICa2+ levels were within our reference range, but the ICa2+/IMg2+ ratio was elevated (P<.01) in menstrual migraine. CONCLUSIONS: The high incidence of IMg2+ deficiency and the elevated ICa2+/IMg2+ ratio during menstrual migraine confirm previous suggestions of a possible role for magnesium deficiency in the development of menstrual migraine.

Calcium↗
PubMedDate not supplied

Long-term migraine prevention with topiramate: open-label extension of pivotal trials.

OBJECTIVE: To demonstrate that topiramate is an effective and generally well-tolerated migraine preventive therapy when used for up to 14 months. BACKGROUND: Topiramate 100 and 200 mg/d significantly reduced mean monthly migraine frequency during 2 large, 26-week, randomized, placebo-controlled trials. Only a small number of clinical trials have examined the long-term (> or =1 year) effectiveness and safety of migraine preventive therapies. METHODS: Five hundred sixty-seven patients with an established history of migraine with or without aura were enrolled in this 8-month, open-label extension of 2 large (49 US and 52 US and Canadian medical centers), randomized, double-blind, placebo-controlled, parallel group, 26-week trials of identical design. To be eligible for the open-label extension, patients were required to have either completed the double-blind phase of the 2 pivotal migraine prevention trials or withdrew after 4 weeks due to lack of efficacy. All eligible patients, regardless of type or dose of study medication (topiramate or placebo) received in the double-blind phase, were titrated to a clinically effective dose of open-label topiramate based on physician judgment of patient response. Efficacy of topiramate was measured as the change in mean monthly migraine frequency. RESULTS: The mean topiramate dose during the open-label extension phase was 124.7 mg/d and 150.3 mg/d for patients on placebo (n = 159) or topiramate (n = 408), respectively, during the double-blind phase (N = 567, 91% female, mean age 39.4 years). Patients on topiramate for up to 14 months had 2.2 +/- 2.4 (mean +/- SD) migraines per month after completion of the open-label extension phase (3.4 +/- 2.6 at double-blind endpoint). Patients on topiramate during the open-label extension phase only (placebo during the double-blind phase) had 3.0 +/- 2.9 migraines per month at open-label extension endpoint (4.9 +/- 3.0 migraines per month at double-blind endpoint). Discontinuation rates due to adverse events during the double-blind phase were 22.2% for patients on topiramate and 11.0% for patients on placebo. Discontinuation rates due to adverse events during the open-label extension phase were 8.6% for those patients who had already received topiramate during the double-blind phase and 20.9% for those patients who had previously received placebo. CONCLUSIONS: Patients receiving topiramate experienced a sustained reduction in migraine frequency for up to 14 months. The effectiveness and safety of topiramate was consistent with that observed during 2 26-week pivotal trials.

Adolescent↗