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MigrainePhase 3ADAMNCT03282227

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

A Phase 3 study testing M207 Microneedle System in people with Migraine, run by Zosano Pharma Corporation at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
M207 Microneedle System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
31 sitesUnited States
Study dates
7 Nov 2017to 17 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:
  4. at least 2 migraines per month
  5. no more than 8 migraines per month
  6. no more than 15 headache days per month
  7. 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.
  8. 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
  1. History or current abuse or dependence on alcohol or drugs

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Primary Care Associates/Radiant Research

    Anderson, South Carolina, 29621

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303-3041

  • University of Texas Southwestern Medical Center - Neurology Clinic

    Dallas, Texas, 75390

  • Colorado Allergy Asthma Centers

    Denver, Colorado, 80230

  • Lillestol Research

    Fargo, North Dakota, 58103

  • Harmony Medical Research Institute

    Hialeah, Florida, 33016

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Downtown L.A. Research Center

    Los Angeles, California, 90017

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Raleigh Medical Group PMG Research

    Raleigh, North Carolina, 27609

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Allergy Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Clinvest Research

    Springfield, Missouri, 65810

  • Empire Clinical Research

    Upland, California, 91786

  • MedVadis Research Corporation

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

Official title: 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 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.

Read the 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.

Conditions
Migraine
Being tested
M207 Microneedle System
Keywords
migraine, migraine headache, acute migraine, acute migraine headache
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M207 Microneedle SystemDrug

    Also called ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan

    M207 Microneedle System 3.8 mg

Study groups in NCT03282227
Study groupRoleWhat they receive
M207 Microneedle System 3.8 mgExperimentalM207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Receives: Drug: M207 Microneedle System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 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.

    Measured: 0 to 12 months

Secondary outcomes (6)

  1. Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

  2. Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

  3. Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

  4. Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

  5. Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

  6. Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose

    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.

    Measured: 2 hours for each Migraine, up to 12 months for each subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2017
  2. Study start7 Nov 2017
  3. Primary completion17 May 2019
  4. Study completion17 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single dose, open-label treatment
Masking
None (open label)
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282227
Sponsor's protocol ID
CP-2017-001
Acronym
ADAM
Status last verified
Aug 2020
First submitted
5 Sep 2017
Last updated
19 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nahas SJ, Hindiyeh N, Friedman DI, Elbuluk N, Kellerman DJ, Foreman PK, Schmidt P. Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine. J Headache Pain. 2021 May 17;22(1):37. doi: 10.1186/s10194-021-01249-z.

    PubMed 34001002

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing M207 Microneedle System in people with Migraine, run by Zosano Pharma Corporation at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020; AzTrials last refreshed its copy on 2 Nov 2026.

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