IngentaConnect Repetitive dihydroergotamine nasal spray for treatment of refract...

Abstract:

Objective: To evaluate the safety and efficacy of a repetitive intranasal (IN) dihydroergotamine (DHE) burst protocol for treatment of refractory headaches.

Research design and methods: Patients with refractory headaches were enrolled in a prospective, open-label, pilot study. Patients were instructed to self-administer IN DHE every 8 hours for 3 days; each IN DHE dose consisted of one 0.5-mg spray in each nostril that was repeated 15 minutes later, for a total of 2.0 mg DHE per dose. Follow-up visits were scheduled approximately 3 weeks later.

Main outcome measures: Efficacy and safety measurements were collected during patient interviews. Primary efficacy measures were the change in headache frequency, duration, and severity (rated from 0 [none] to 5 [extremely severe]) between the initial and follow-up visits. Safety was assessed at the follow-up visits through the occurrence of adverse events (AEs).

Results: Twenty-six patients were enrolled in the study. Follow-up visits were completed by 24 patients whose mean headache frequency at study entry was 6.6 d/wk. The IN DHE burst protocol was associated with significant mean decreases in headache frequency (2.6 d/wk, p < 0.001), duration (5.8 hours, p = 0.03), and severity (1.2 units, p < 0.001) between study entry and the follow-up visit. One patient discontinued IN DHE use early because of an AE (nasal stuffiness); two additional patients each reported one AE (fatigue and increased headache) that was attributed to IN DHE.

Conclusions: The results of this pilot study suggest that the IN DHE burst protocol may be an effective and safe treatment for refractory headaches; interpretation of these results is limited by the open-label, uncontrolled design and the small number of patients. The development of a double-blind, placebo-controlled study to further evaluate this treatment regimen is warranted.

Keywords: DIHYDROERGOTAMINE; INTRANASAL; RASKIN PROTOCOL; REFRACTORY HEADACHE

Document Type: Case report

DOI: 10.1185/030079906X148247

Affiliations: 1: Michigan Head-Pain & Neurological Institute, Ann Arbor, MI, USA

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Repetitive dihydroergotamine nasal spray for treatment of refractory headaches: an open-label pilot study