Phase 2
N=75
Staccato Prochlorperazine in Migraine (in Clinic)
Migraine Headache, With or Without Aura
Bottom Line
View on ClinicalTrials.gov: NCT00610428 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Headache Pain Relief at 2 hr Post-dose by 2-point Definition — 6; 11; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Staccato Placebo (Drug); Staccato Prochlorperazine 5 mg (Drug); Staccato Prochlorperazine 10 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alexza Pharmaceuticals, Inc.
- Primary completion
- Oct 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Headache Pain Relief at 2 hr Post-dose by 2-point Definition |
6; 11; 13 | — |
| SECONDARY Survival Analysis for Time to Pain Relief |
115.4; 96.5; 88.6 | 0.0840 |
Summary
Development of Staccato Prochlorperazine for the treatment of migraine headache.
Eligibility Criteria
Inclusion Criteria
- Subjects who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of Moderate or Severe prior to dosing.
Exclusion Criteria
- Subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
Data sourced from ClinicalTrials.gov (NCT00610428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.