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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M207 Microneedle System 3.8 mg | Experimental | M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M207 Microneedle System | Drug | M207 Microneedle System 3.8 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
History or current abuse or dependence on alcohol or drugs
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| Name | Affiliation | Role |
|---|---|---|
| Don Kellerman, Pharm.D. | Zosano Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research | Birmingham | Alabama | 35216 | United States | ||
| Elite Clinical Studies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001002 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | M207 Microneedle System 3.8 mg | M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches) M207 Microneedle System: M207 Microneedle System 3.8 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Jul 7, 2020 |
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Single dose, open-label treatment
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Open-label
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| 2 hours for each Migraine, up to 12 months for each subject |
| 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. | 2 hours for each Migraine, up to 12 months for each subject |
| 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. | 2 hours for each Migraine, up to 12 months for each subject |
| 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. | 2 hours for each Migraine, up to 12 months for each subject |
| 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. | 2 hours for each Migraine, up to 12 months for each subject |
| 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. | 2 hours for each Migraine, up to 12 months for each subject |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Downtown L.A. Research Center | Los Angeles | California | 90017 | United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| Allergy Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Empire Clinical Research | Upland | California | 91786 | United States |
| Colorado Allergy Asthma Centers | Denver | Colorado | 80230 | United States |
| Harmony Medical Research Institute | Hialeah | Florida | 33016 | United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472 | United States |
| Michigan Headache and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303-3041 | United States |
| Clinvest Research | Springfield | Missouri | 65810 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Raleigh Medical Group PMG Research | Raleigh | North Carolina | 27609 | United States |
| Lillestol Research | Fargo | North Dakota | 58103 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Primary Care Associates/Radiant Research | Anderson | South Carolina | 29621 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| University of Texas Southwestern Medical Center - Neurology Clinic | Dallas | Texas | 75390 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Completed at Least 6 Months |
|
| COMPLETED | Completed 12 Months |
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| NOT COMPLETED |
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Safety population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).
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| ID | Title | Description |
|---|---|---|
| BG000 | M207 Microneedle System 3.8 mg | M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches) M207 Microneedle System: M207 Microneedle System 3.8 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch). | Posted | Count of Participants | Participants | 0 to 12 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data. | Posted | Count of Units | Qualifying migraines with 2 hour data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hour data | Qualifying migraines with 2 hour data |
|
| |||||||||||||||||||||||||
| Secondary | 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. | Modified Intent-to-Treat Population included all subjects who received | Posted | Count of Units | Qualifying migraines with 2 hr data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hr data | Qualifying migraines with 2 hr data |
|
| |||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data. | Posted | Count of Units | Qualifying migraines with 2 hr data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hr data | Qualifying migraines with 2 hr data |
|
| |||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data. | Posted | Count of Units | Qualifying migraines with 2 hr data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hr data | Qualifying migraines with 2 hr data |
|
| |||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data. | Posted | Count of Units | Qualifying migraines with 2 hour data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hour data | Qualifying migraines with 2 hour data |
|
| |||||||||||||||||||||||||
| Secondary | 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. | Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data. | Posted | Count of Units | Qualifying migraines with 2 hour data | 2 hours for each Migraine, up to 12 months for each subject | Qualifying migraines with 2 hour data | Qualifying migraines with 2 hour data |
|
|
0-12 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M207 Microneedle System 3.8 mg | M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches) M207 Microneedle System: M207 Microneedle System 3.8 mg | 0 | 335 | 5 | 335 | 323 | 335 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Foetal disorder | Congenital, familial and genetic disorders | MedDRA 20.0 | Non-systematic Assessment | Fetal chromosomal disorder |
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| Procedural pain | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Breast cancer stage II | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site swelling | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site bruise | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site pain | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site discolouration | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site oedema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Kellerman, PharmD, Sr. VP, Clin Dev and Med Affairs | Zosano Pharma Corporation | (510) 745-4004 | dkellerman@zosanopharma.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 6, 2018 | Jul 7, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Qualifying migraines with 2 hour data |
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| Qualifying migraines with 2 hr data |
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| Qualifying migraines with 2 hr data |
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| Qualifying migraines with 2 hr data |
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| Qualifying migraines with 2 hour data |
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| Qualifying migraines with 2 hour data |
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