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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
September 5, 2017
September 13, 2017
November 10, 2017
November 7, 2017
March 2019   (Final data collection date for primary outcome measure)
Long-term safety as measured by incidence of adverse events [ Time Frame: 12 months ]
Long-term safety as measured by incidence of adverse events
Same as current
Complete list of historical versions of study NCT03282227 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
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.
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Intervention Model Description:
Single dose, open-label treatment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Migraine
Drug: M207 Microneedle System
M207 Microneedle System 3.8 mg
Other Names:
  • ZP-Zolmitriptan Intracutaneous Microneedle System
  • ADAM-Zolmitriptan
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Whitney Halladay 510-745-4011 whalladay@zosanopharma.com
Contact: Pete Schmidt, MD 510-745-1251 pschmidt@zosanopharma.com
United States
 
 
NCT03282227
CP-2017-001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Zosano Pharma Corporation
Zosano Pharma Corporation
Not Provided
Study Director: Don Kellerman, Pharm.D. Zosano Pharma Corporation
Zosano Pharma Corporation
November 2017

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