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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
M207 Microneedle System
Sponsored by
Zosano Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, migraine headache, acute migraine, acute migraine headache

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Achieve Clinical Research
  • Elite Clinical Studies
  • Downtown L.A. Research Center
  • Stanford University Medical Center
  • Allergy Asthma Associates of Santa Clara Valley Research Center
  • California Medical Clinic for Headache
  • Empire Clinical Research
  • Colorado Allergy Asthma Centers
  • Harmony Medical Research Institute
  • Advanced Clinical Research
  • DelRicht Research
  • Boston Clinical Trials
  • MedVadis Research Corporation
  • Michigan Headache and Neurological Institute
  • Clinical Research Institute
  • Clinical Research Institute
  • StudyMetrix Research LLC
  • Clinvest Research
  • Dartmouth-Hitchcock Medical Center
  • Albuquerque Clinical Trials
  • Rochester Clinical Research
  • Peters Medical Research
  • North Carolina Clinical Research
  • Raleigh Medical Group PMG Research
  • Lillestol Research
  • Thomas Jefferson University
  • Primary Care Associates/Radiant Research
  • Coastal Carolina Research Center
  • FutureSearch Trials of Neurology
  • University of Texas Southwestern Medical Center - Neurology Clinic
  • Central Texas Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M207 Microneedle System 3.8 mg

Arm Description

M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 5, 2017
Last Updated
August 7, 2020
Sponsor
Zosano Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03282227
Brief Title
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Acronym
ADAM
Official Title
A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zosano Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, migraine headache, acute migraine, acute migraine headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Single dose, open-label treatment
Masking
None (Open Label)
Masking Description
Open-label
Allocation
N/A
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M207 Microneedle System 3.8 mg
Arm Type
Experimental
Arm Description
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Intervention Type
Drug
Intervention Name(s)
M207 Microneedle System
Other Intervention Name(s)
ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan
Intervention Description
M207 Microneedle System 3.8 mg
Primary Outcome Measure Information:
Title
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
Description
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.
Time Frame
0 to 12 months
Secondary Outcome Measure Information:
Title
Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject
Title
Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject
Title
Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject
Title
Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject
Title
Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject
Title
Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose
Description
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.
Time Frame
2 hours for each Migraine, up to 12 months for each subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Women or men 18 to 75 years of age Greater than 1 year history of episodic, migraine (with or without aura) with onset prior to 50 years of age. Migraine history during the prior 6 months must include: at least 2 migraines per month no more than 8 migraines per month no more than 15 headache days per month 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. 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: Contraindication to triptans Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs like Coumadin®) Known allergy or sensitivity to zolmitriptan or its derivatives or formulations Known allergy or sensitivity to adhesives and/or titanium Women who are pregnant, breast-feeding or plan a pregnancy during this study 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 History or current abuse or dependence on alcohol or drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Kellerman, Pharm.D.
Organizational Affiliation
Zosano Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Downtown L.A. Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Allergy Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Colorado Allergy Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Harmony Medical Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Michigan Headache and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
StudyMetrix Research LLC
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303-3041
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Raleigh Medical Group PMG Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Primary Care Associates/Radiant Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Texas Southwestern Medical Center - Neurology Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34001002
Citation
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.
Results Reference
derived

Learn more about this trial

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

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