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 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 days per week. The IN DHE burst protocol was associated with significant mean decreased in headache frequency, duration, and severity 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.