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

This study is currently recruiting participants.
Verified November 2017 by Zosano Pharma Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03282227
First Posted: September 13, 2017
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Zosano Pharma Corporation
  Purpose
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 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.

Condition Intervention Phase
Migraine Drug: M207 Microneedle System Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Single dose, open-label treatment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine

Resource links provided by NLM:


Further study details as provided by Zosano Pharma Corporation:

Primary Outcome Measures:
  • Long-term safety as measured by incidence of adverse events [ Time Frame: 12 months ]
    Long-term safety as measured by incidence of adverse events


Secondary Outcome Measures:
  • Proportion of subjects with pain freedom [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with pain freedom

  • Proportion of subjects with most bothersome symptom freedom [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with freedom from most bothersome symptom other than pain

  • Proportion of subjects with pain relief [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with pain relief

  • Proportion of subjects with nausea freedom [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with nausea freedom

  • Proportion of subjects with photophobia freedom [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with photophobia freedom

  • Proportion of subjects with phonophobia freedom [ Time Frame: 30 minutes; 2, 12, 24, 48 hours ]
    Proportion of subjects with phonophobia freedom


Estimated Enrollment: 250
Actual Study Start Date: November 7, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M207 Microneedle System 3.8 mg
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Drug: M207 Microneedle System
M207 Microneedle System 3.8 mg
Other Names:
  • ZP-Zolmitriptan Intracutaneous Microneedle System
  • ADAM-Zolmitriptan

Detailed Description:
This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period (14 to 21 days) to determine eligibility for treatment with study medication based on daily eDiary data collection. Qualified subjects will receive study medication on Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be treated with a single dose, consisting of two patches, but subjects can treat multiple migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Women or men 18 to 75 years of age
  2. Greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age.
  3. Migraine history during the prior 6 months must include:

    1. at least 2 migraines per month
    2. no more than 8 migraines per month
    3. no more than 15 headache days per month
  4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial.
  5. Willing and able to treat a minimum of 2 migraines per month with study medication and consistently complete eDiary for up to 12 months.

Main Exclusion Criteria:

  1. Contraindication to triptans
  2. Use of SSRIs (drugs like Prozac®) or SNRIs (drugs like Effexor®) or anti-coagulants (drugs like Coumadin®)
  3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  4. Known allergy or sensitivity to adhesives and/or titanium
  5. Women who are pregnant, breast-feeding or plan a pregnancy during this study
  6. Three or more of the following cardiovascular risk factors:

    • Current tobacco use
    • Hypertension or receiving anti-hypertensive medication for hypertension
    • Hyperlipidemia or on prescribed anti-cholesterol treatment
    • Family history of premature coronary artery disease
    • Diabetes mellitus
  7. History or current abuse or dependence on alcohol or drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282227


Contacts
Contact: Whitney Halladay 510-745-4011 whalladay@zosanopharma.com
Contact: Pete Schmidt, MD 510-745-1251 pschmidt@zosanopharma.com

Locations
United States, Missouri
StudyMetrix Research LLC Recruiting
Saint Peters, Missouri, United States, 63303-3041
Contact: Donna Straatmann    636-387-5100    dstraatmann@studymetrix.com   
Principal Investigator: Timothy Smith, MD         
United States, North Carolina
Peters Medical Research Recruiting
High Point, North Carolina, United States, 27262
Contact: Wendy Meris    336-883-9773    wendym@petersmedicalresearch.com   
Principal Investigator: Thomas Jarrett, MD         
Sponsors and Collaborators
Zosano Pharma Corporation
Investigators
Study Director: Don Kellerman, Pharm.D. Zosano Pharma Corporation
  More Information

Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT03282227     History of Changes
Other Study ID Numbers: CP-2017-001
First Submitted: September 5, 2017
First Posted: September 13, 2017
Last Update Posted: November 10, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zosano Pharma Corporation:
migraine
migraine headache
acute migraine
acute migraine headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Oxazolidinones
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors