PMID- 17022862
OWN - NLM
STAT- MEDLINE
DCOM- 20061024
LR  - 20131121
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 22
IP  - 10
DP  - 2006 Oct
TI  - Repetitive dihydroergotamine nasal spray for treatment of refractory headaches: 
      an open-label pilot study.
PG  - 2031-6
AB  - 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.
FAU - Weintraub, James
AU  - Weintraub J
AD  - Michigan Head-Pain & Neurological Institute, Ann Arbor, MI 48104, USA. 
      drtraub@aol.com
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Vasoconstrictor Agents)
RN  - 436O5HM03C (Dihydroergotamine)
SB  - IM
MH  - Administration, Intranasal
MH  - Adult
MH  - Dihydroergotamine/*administration & dosage/therapeutic use
MH  - Female
MH  - Headache Disorders, Primary/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Vasoconstrictor Agents/*administration & dosage/therapeutic use
EDAT- 2006/10/07 09:00
MHDA- 2006/10/25 09:00
CRDT- 2006/10/07 09:00
PHST- 2006/10/07 09:00 [pubmed]
PHST- 2006/10/25 09:00 [medline]
PHST- 2006/10/07 09:00 [entrez]
AID - 10.1185/030079906X148247 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2006 Oct;22(10):2031-6. doi: 10.1185/030079906X148247.