Staccato Prochlorperazine in Migraine (in Clinic)

NCT00610428 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AMDC-001-201
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Development of Staccato Prochlorperazine for the treatment of migraine headache.

Conditions

Migraine Headache, With or Without Aura

Keywords

Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.

Outcome Measures

Primary Outcomes (1)

• Headache Pain Relief at 2 hr Post-dose by 2-point Definition

  patient headache pain relief defined as a 2 point reduction as measured on the scale: 0=NO headache pain, 1 = MILD headache pain, 2 = MODERATE headache pain, 3 = SEVERE headache pain

  2 hours after treatment

Secondary Outcomes (1)

• Survival Analysis for Time to Pain Relief

  from treatment (time = 0) to 2 hours post treatment

Study Arms (3)

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled Staccato Placebo

Drug: Staccato Placebo

Inhaled PCZ 5 mg

EXPERIMENTAL

Inhaled Staccato Prochlorperazine 5 mg

Drug: Staccato Prochlorperazine 5 mg

Inhaled PCZ 10 mg

PLACEBO COMPARATOR

Inhaled Staccato Prochlorperazine 10 mg

Drug: Staccato Prochlorperazine 10 mg

Interventions

Staccato Placebo DRUG

Inhaled Staccato Placebo

Inhaled Placebo

Staccato Prochlorperazine 5 mg DRUG

Inhaled Prochlorperazine 5 mg

Inhaled PCZ 5 mg

Staccato Prochlorperazine 10 mg DRUG

Inhaled Prochlorperazine10 mg

Inhaled PCZ 10 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (1)

Arthur H. Elkind, MD

Mount Vernon, New York, 10550, United States

Location

Related Publications (1)

• Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1.

  PMID: 18830225 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Executive VP, Research & Development, Regulatory & Quality
• Organization: Alexza Pharmaceuticals, Inc

ClinicalTrialsInfo@alexza.com

650.944.7071

Study Officials

• Sheena Auroa, MD

  PRINCIPAL INVESTIGATOR

• Roger K Cady, MD

  PRINCIPAL INVESTIGATOR

• Arthur Elkind, MD

  PRINCIPAL INVESTIGATOR

• Fred Freitag, DO

  PRINCIPAL INVESTIGATOR

• Lisa Mannix, MD

  PRINCIPAL INVESTIGATOR

• Niana T Mathew, MD

  PRINCIPAL INVESTIGATOR

• Egilius LH Spierings, MD

  PRINCIPAL INVESTIGATOR

• Stewart Tepper, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: March 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2008-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)