Staccato Prochlorperazine in Migraine (in Clinic)

Alexza Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Migraine Headache, With or Without Aura

Treatments: Drug: Staccato Prochlorperazine 5 mg; Drug: Staccato Placebo; Drug: Staccato Prochlorperazine 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610428

AMDC-001-201

Details and patient eligibility

About

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Inhaled Placebo

Placebo Comparator group

Description:

Inhaled Staccato Placebo

Treatment:

Drug: Staccato Placebo

Inhaled PCZ 5 mg

Experimental group

Description:

Inhaled Staccato Prochlorperazine 5 mg

Treatment:

Drug: Staccato Prochlorperazine 5 mg

Inhaled PCZ 10 mg

Placebo Comparator group

Description:

Inhaled Staccato Prochlorperazine 10 mg

Treatment:

Drug: Staccato Prochlorperazine 10 mg