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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
Results First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

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 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: M207 Microneedle System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
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
Official Title: A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months [ Time Frame: 0 to 12 months ]
    Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.


Secondary Outcome Measures :
  1. Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of migraine attacks for which pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.

  2. Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of migraine attacks for which freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.

  3. Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of migraine attacks for which pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.

  4. Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.

  5. Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.

  6. Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose [ Time Frame: 2 hours for each Migraine, up to 12 months for each subject ]
    Percentage of migraine attacks for which phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or norepinephrine reuptake inhibitors (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

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


Locations
Show Show 31 study locations
Sponsors and Collaborators
Zosano Pharma Corporation
Investigators
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Study Director: Don Kellerman, Pharm.D. Zosano Pharma Corporation
  Study Documents (Full-Text)

Documents provided by Zosano Pharma Corporation:
Statistical Analysis Plan  [PDF] November 30, 2018
Study Protocol  [PDF] April 6, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT03282227    
Other Study ID Numbers: CP-2017-001
First Posted: September 13, 2017    Key Record Dates
Results First Posted: August 19, 2020
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxazolidinones
Zolmitriptan
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