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Speed of onset, efficacy and tolerability of zolmitriptan nasal spray in the acute treatment of migraine: a randomised, double-blind, placebo-controlled study.
CNS Drugs. 2005; 19(2):125-36.CD

Abstract

INTRODUCTION

Migraine is a common, disabling condition that has a significant impact on patients and relatives, and is a considerable economic burden on society. Migraine patients want fast-acting treatments with high efficacy. Previous studies have demonstrated that orally administered formulations of zolmitriptan are rapidly and highly effective in the acute treatment of migraine. The objective of this study was to assess the efficacy, speed of onset and tolerability of the nasal spray formulation of zolmitriptan in migraine treatment.

METHODS

This multicentre, randomised, double-blind study recruited 2122 patients (aged 18-65 years) who had an established diagnosis of migraine (according to International Headache Society criteria), with or without aura. Patients were randomised to receive zolmitriptan 5mg nasal spray or placebo to treat up to two migraine attacks within 15 minutes of headache pain becoming moderate or severe. The primary endpoint was headache response (reduction in migraine pain from severe/moderate to mild/none) at 2 hours, 1 hour, 30 minutes and 15 minutes post-dose (analysed using a step-down approach). Secondary endpoints included headache response at 4 hours, pain-free rates at 30 minutes and 1, 2 and 4 hours, and sustained headache response and pain-free status at 24 hours post-dose.

RESULTS

The headache response rate at 2 hours post-dose was 66.2% for the zolmitriptan group, compared with 35.0% for the placebo group (p < 0.001). Zolmitriptan nasal spray also produced significantly higher headache response rates than placebo at all earlier timepoints assessed, starting as early as 15 minutes post-dose (p < 0.001). Similar results were obtained for the analysis of the first attack. Significantly higher pain-free rates were obtained with zolmitriptan nasal spray, compared with placebo, from 15 minutes post-dose onward (p < 0.005). Zolmitriptan nasal spray was also significantly superior to placebo for headache response at 4 hours, sustained headache response at 24 hours and sustained pain-free rate at 24 hours. Zolmitriptan nasal spray was well tolerated, with most adverse events being of short duration and mild or moderate intensity.

CONCLUSIONS

Zolmitriptan nasal spray is highly effective in the acute treatment of migraine and has a very fast onset of action, producing significant headache response and pain-free rates as early as 15 minutes post-dose (the earliest assessment in this study). In addition to the very fast onset of action, zolmitriptan nasal spray produced significantly higher sustained headache response and pain-free rates at 24 hours post-dose compared with placebo. These desirable efficacy outcomes were combined with good tolerability.

Authors+Show Affiliations

Department of Neurology, Mayo Clinic College of Medicine, Scottsdale, Arizona 85259, USA. Dodick.David@mayo.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15697326

Citation

Dodick, David, et al. "Speed of Onset, Efficacy and Tolerability of Zolmitriptan Nasal Spray in the Acute Treatment of Migraine: a Randomised, Double-blind, Placebo-controlled Study." CNS Drugs, vol. 19, no. 2, 2005, pp. 125-36.
Dodick D, Brandes J, Elkind A, et al. Speed of onset, efficacy and tolerability of zolmitriptan nasal spray in the acute treatment of migraine: a randomised, double-blind, placebo-controlled study. CNS Drugs. 2005;19(2):125-36.
Dodick, D., Brandes, J., Elkind, A., Mathew, N., & Rodichok, L. (2005). Speed of onset, efficacy and tolerability of zolmitriptan nasal spray in the acute treatment of migraine: a randomised, double-blind, placebo-controlled study. CNS Drugs, 19(2), 125-36.
Dodick D, et al. Speed of Onset, Efficacy and Tolerability of Zolmitriptan Nasal Spray in the Acute Treatment of Migraine: a Randomised, Double-blind, Placebo-controlled Study. CNS Drugs. 2005;19(2):125-36. PubMed PMID: 15697326.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Speed of onset, efficacy and tolerability of zolmitriptan nasal spray in the acute treatment of migraine: a randomised, double-blind, placebo-controlled study. AU - Dodick,David, AU - Brandes,Jan, AU - Elkind,Arthur, AU - Mathew,Ninan, AU - Rodichok,Lawrence, PY - 2005/2/9/pubmed PY - 2005/4/26/medline PY - 2005/2/9/entrez SP - 125 EP - 36 JF - CNS drugs JO - CNS Drugs VL - 19 IS - 2 N2 - INTRODUCTION: Migraine is a common, disabling condition that has a significant impact on patients and relatives, and is a considerable economic burden on society. Migraine patients want fast-acting treatments with high efficacy. Previous studies have demonstrated that orally administered formulations of zolmitriptan are rapidly and highly effective in the acute treatment of migraine. The objective of this study was to assess the efficacy, speed of onset and tolerability of the nasal spray formulation of zolmitriptan in migraine treatment. METHODS: This multicentre, randomised, double-blind study recruited 2122 patients (aged 18-65 years) who had an established diagnosis of migraine (according to International Headache Society criteria), with or without aura. Patients were randomised to receive zolmitriptan 5mg nasal spray or placebo to treat up to two migraine attacks within 15 minutes of headache pain becoming moderate or severe. The primary endpoint was headache response (reduction in migraine pain from severe/moderate to mild/none) at 2 hours, 1 hour, 30 minutes and 15 minutes post-dose (analysed using a step-down approach). Secondary endpoints included headache response at 4 hours, pain-free rates at 30 minutes and 1, 2 and 4 hours, and sustained headache response and pain-free status at 24 hours post-dose. RESULTS: The headache response rate at 2 hours post-dose was 66.2% for the zolmitriptan group, compared with 35.0% for the placebo group (p < 0.001). Zolmitriptan nasal spray also produced significantly higher headache response rates than placebo at all earlier timepoints assessed, starting as early as 15 minutes post-dose (p < 0.001). Similar results were obtained for the analysis of the first attack. Significantly higher pain-free rates were obtained with zolmitriptan nasal spray, compared with placebo, from 15 minutes post-dose onward (p < 0.005). Zolmitriptan nasal spray was also significantly superior to placebo for headache response at 4 hours, sustained headache response at 24 hours and sustained pain-free rate at 24 hours. Zolmitriptan nasal spray was well tolerated, with most adverse events being of short duration and mild or moderate intensity. CONCLUSIONS: Zolmitriptan nasal spray is highly effective in the acute treatment of migraine and has a very fast onset of action, producing significant headache response and pain-free rates as early as 15 minutes post-dose (the earliest assessment in this study). In addition to the very fast onset of action, zolmitriptan nasal spray produced significantly higher sustained headache response and pain-free rates at 24 hours post-dose compared with placebo. These desirable efficacy outcomes were combined with good tolerability. SN - 1172-7047 UR - https://www.unboundmedicine.com/medline/citation/15697326/Speed_of_onset_efficacy_and_tolerability_of_zolmitriptan_nasal_spray_in_the_acute_treatment_of_migraine:_a_randomised_double_blind_placebo_controlled_study_ L2 - https://dx.doi.org/10.2165/00023210-200519020-00003 DB - PRIME DP - Unbound Medicine ER -