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A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine

NCT03282227 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2020-08-19

Study results available
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Summary

This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the electronic diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the eDiary post treatment administration.

Conditions

Interventions

DRUG

M207 Microneedle System

M207 Microneedle System 3.8 mg

Sponsors & Collaborators

  • Zosano Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Don Kellerman, Pharm.D. · Zosano Pharma Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2019-05-17
Completion
2019-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282227 on ClinicalTrials.gov