Time to pain freedom and onset of pain relief with rizatriptan 10 mg and prescription usual-care oral medications in the acute treatment of migraine headaches: A multicenter, prospective, open-label, two-attack, crossover study

2006 ◽  
Vol 28 (6) ◽  
pp. 872-880 ◽  
Author(s):  
Christopher F. Bell ◽  
Kathleen A. Foley ◽  
Suna Barlas ◽  
Glen Solomon ◽  
X. Henry Hu
Cephalalgia ◽  
2006 ◽  
Vol 26 (3) ◽  
pp. 246-256 ◽  
Author(s):  
MJA Láinez ◽  
S Evers ◽  
E Kinge ◽  
G Allais ◽  
C Allen ◽  
...  

Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more ( P ≤ 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P ≤ 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies.


Geriatrics ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. 61
Author(s):  
Mark Forman ◽  
Alex Kouassi ◽  
Teresa Brandt ◽  
Lee Barsky ◽  
Cynthia Zamora ◽  
...  

Dysphagia (difficulty swallowing) affects up to 13% of persons 65 years and older and 51% of older persons in nursing homes and can contribute to reduced adherence to oral medications. This was an exploratory, single-center, open-label, randomized, crossover study in healthy older adult participants. Primary objectives were evaluation of palatability (taste) and swallowability of the contents of pimavanserin 34 mg capsules mixed with selected soft foods or a liquid nutritional supplement. Secondary objectives included evaluation of additional palatability endpoints and ease of capsule manipulation for mixing. A total of 18 healthy, older adult participants (mean age 65 years) were included. Mean participant ratings for all food vehicles were “moderately like” to “neither like nor dislike” for palatability and “very easy” to “somewhat easy” for swallowability. Capsule manipulation to allow sprinkling of contents was rated “very easy” or “somewhat easy” by most participants. There were five treatment-emergent adverse events, all mild; two were deemed related to study treatment. The palatability and swallowability of pimavanserin was considered acceptable when administered with certain soft foods or a liquid nutritional supplement by the study participants.


US Neurology ◽  
2016 ◽  
Vol 12 (02) ◽  
pp. 84
Author(s):  
Deborah I Friedman ◽  

Migraine remains a common debilitating condition that exerts a high social and economic burden worldwide. Despite the widespread availability of various medications for migraine, many patients are dissatisfied with their treatment. Rapid and effective treatment at an early stage in an attack is vital in migraine to prevent central sensitization leading to attacks that are difficult to treat. Most migraineurs prefer oral medications but this is not always the most rapid or efficient route into the bloodstream. Intranasal administration of migraine treatment provides a rapid, convenient and reliable alternative to oral and other routes. AVP-825 is an intranasal medication delivery system approved by the US Food and Drug Administration in January 2016 as ONZETRA™ Xsail™ (sumatriptan nasal powder [Avanir Pharmaceuticals, Aliso Viejo, CA]) for the acute treatment of migraine with or without aura in adults. AVP-825 contains low dose sumatriptan powder and takes advantage of some unique aspects of the nasal anatomy to confer rapid pain relief in the acute treatment of migraine. In two Phase III trials, AVP-825 was well tolerated and showed significantly faster migraine pain relief and relief from other symptoms including photophobia, phonophobia, and nausea than placebo or oral sumatriptan. This benefit was achieved with substantially lower drug exposure than oral sumatriptan. Additional analyses of data from the Phase III trials show that significantly more patients with migraine receiving AVP-825 reported clinically meaningful relief, sustained relief, pain freedom, lower migraine-related disability and more consistent relief across multiple attacks than those receiving oral sumatriptan. The rapid and sustained action of AVP-825 and its convenience creates the potential for this unique treatment to reduce the burden of migraine in many patients.


Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.


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