At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
Prochlorperazine 0.5 mg IV over 5 sec +7 moredrug
Likely dose
Prochlorperazine 0.5 mg IV over 5 secfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Prochlorperazine 0.5 mg IV over 5 sec, Inhaled prochlorperazine 0.625 mg, and 6 other interventions for Migraine. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
CollaboratorsPPD Development, LP
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionOct 2004
First PostedFeb 2008
TodayJul 2026
First PostedFeb 8, 2008
Enrollment StartAug 1, 2004
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.4 years ago
Interventions
Prochlorperazine 0.5 mg IV over 5 secdrug
IV Prochlorperazine for bioavailability
Inhaled prochlorperazine 0.625 mgdrug
Inhaled Staccato Prochlorperazine 0.625 mg
Inhaled prochlorperazine 1.25 mgdrug
Inhaled Staccato Prochlorperazine 1.25 mg
Inhaled prochlorperazine 2.5 mgdrug
Inhaled Staccato Prochlorperazine 2.5 mg
Inhaled prochlorperazine 5 mgdrug
InhaledStaccato Prochlorperazine 5 mg
Inhaled prochlorperazine 10 mgdrug
InhaledStaccato Prochlorperazine 10 mg
Inhaled placebodrug
Inhaled Staccato Placebo (0 mg)
Prochlorperazine 10 mg IV over 5 secdrug
Prochlorperazine 10 mg IV over 5 sec for patient qualification