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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282227
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE November 7, 2017
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Long-term safety as measured by incidence of adverse events [ Time Frame: 12 months ]
Long-term safety as measured by incidence of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Official Title  ICMJE A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
Brief 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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single dose, open-label treatment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: M207 Microneedle System
M207 Microneedle System 3.8 mg
Other Names:
  • ZP-Zolmitriptan Intracutaneous Microneedle System
  • ADAM-Zolmitriptan
Study Arms  ICMJE Experimental: M207 Microneedle System 3.8 mg
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Intervention: Drug: M207 Microneedle System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
344
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
250
Actual Study Completion Date  ICMJE May 17, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03282227
Other Study ID Numbers  ICMJE CP-2017-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zosano Pharma Corporation
Study Sponsor  ICMJE Zosano Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Don Kellerman, Pharm.D. Zosano Pharma Corporation
PRS Account Zosano Pharma Corporation
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP