MigrainePhase 1NCT03978403
A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study testing M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) and M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups in people with Migraine, run by Zosano Pharma Corporation at 1 site in United States.
Trial summary
This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs ~48 hours apart from patch application, in randomized order. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) and M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 28 Jun 2019
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women or men 18 to 50 years of age (inclusive)
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count, blood chemistry, urinalysis, and ECG.
- Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening and admission/baseline visit.
- Consent of female subjects to use a medically effective method of contraception throughout the entire study period and for 30 days after the subject completes the study. Medically effective methods of contraception that may be used by the subject include abstinence, use of diaphragm and spermicide, intrauterine device (IUD), rings, condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation, hysteroscopic sterilization) and post-menopausal (≥ 2 years of amenorrhea).
- Ability to read, understand, and provide written informed consent that they understand the purpose of the study and procedures required for the study before enrolling in the study, and willingness to comply with all study procedures and restrictions.
Who cannot join
- Evidence of significant history of hepatic, reproductive, gastrointestinal, renal, bleeding, or hematological disorders including coagulation, pulmonary, neurological, respiratory, endocrine, or cardiovascular system abnormalities (especially hypertension, peripheral vascular disease, coronary artery disease, transient ischemic attacks, or cardiac rhythm abnormalities), psychiatric disorders, acute infection, or other conditions that would interfere with study participation or with the absorption, distribution, metabolism, or excretion of drugs.
- Presence of three or more of the following CAD risk factors for cardiovascular disease:
- Current tobacco use (subjects who have smoked within 30 days of screening)
- Hypertension (systolic BP > 140 or diastolic BP > 90) or receiving anti-hypertensive medication for treatment of hypertension
- Hyperlipidemia - LDL > 159 mg/dL and/or HDL < 40 mg/dL (or on prescribed anti-cholesterol treatment)
- Family history of premature coronary artery disease (CAD) (< 55 years of age in male first-degree relatives or < 65 years of age in female first degree relatives)
Show all 35Show fewer
- Diabetes mellitus
- Any contraindication to zolmitriptan administration including:
- History of coronary artery disease or coronary vasospasm
- Symptomatic Wolf-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
- Peripheral Vascular Disease
- Ischemic bowel disease
- Hypertension (greater than or equal to 140/90 mmHg at either the screening or admission/baseline visit
- Any history of hepatic impairment defined as alanine transaminase > 150 U/L, aspartate aminotransferase > 130 U/L or bilirubin > 2 times the upper limit of normal
- History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
- Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application sites from 2 weeks prior to dosing through their last day of study participation
- Use of any prescription anticoagulant within 1 month prior to the first dose
- Use of prescription and over the counter medications within one week of dosing other than the following:
- Hormone Replacement Therapy (HRT)
- Birth control pills, patches, IUD, rings, injections, or implants (all hormonal contraceptives) are allowed provided the dose has been stable for at least three months prior to screening and may be continued throughout the study
- Proton Pump Inhibitors (PPIs)
- Antihistamines
- Intermittently used NSAIDS
- Acetaminophen if medically necessary (not more than 1000 mg/day)
- Exceptions may be allowed on a case by case basis
- Subject has a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
- Subject has a known allergy or sensitivity to tapes or adhesives
- Use of any other investigational compound within 30 days of planned study drug dosing
- Current use or history of drug and/or alcohol abuse within 6 months of screening and deemed to be clinically significant by the investigator
- History of nasal pathology (e.g., polyps) or abnormal nasal exam deemed to be clinically significant by the investigator
- Body Mass Index (BMI) lower than 18 kg/m2 or greater than 35 kg/m2
- If, in the opinion of the investigator, the subject is not suitable for the study
- Any positive urine drug screen result or alcohol test
- Subject currently smokes or is a nicotine a user
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-label Four-way Crossover Study of Pharmacokinetics, Safety, and Tolerability of 3 Formulations of M207 3.8 mg on the Upper Arm for 30 Minutes With Intranasal Zolmitriptan 2.5 mg in Healthy Volunteers
This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs ~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.
Read the detailed description
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur approximately 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
- Conditions
- Migraine
- Being tested
- M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups, Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
- Keywords
- Pharmacokinetics, Healthy, Volunteer
- 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 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches)Drug
Also called Treatment A
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches
M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups)Drug
Also called Treatment B
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups
M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cupsDrug
Also called Treatment C
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches
Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseDrug
Also called Treatment D, Zomig Nasal Spray
Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
| Study group | Role | What they receive |
|---|---|---|
| ABDC | Experimental | A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose Receives: Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose |
| BCAD | Experimental | A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose Receives: Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose |
| CDBA | Experimental | A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose Receives: Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose |
| DACB | Experimental | A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose Receives: Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
Adverse Events
Subjects with treatment emergent adverse events
Measured: 48 hours
Tmax
Time to maximum concentration
Measured: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start29 May 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects are randomized to receive one of four treatment sequences of four open-label treatments 48 hours apart.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zosano Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Kellerman, PharmD, Study director, Zosano Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978403
- Sponsor's protocol ID
- CP-2019-002
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2019
- Last updated
- 18 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Four-way Crossover Study of Pharmacokinetics, Safety, and Tolerability of 3 Formulations of M207 3.8 mg on the Upper Arm for 30 Minutes With Intranasal Zolmitriptan 2.5 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03978403
- Acronym / sponsor ID
- CP-2019-002
- Conditions
- Migraine
- Keywords
- Pharmacokinetics, Healthy, Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zosano Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs ~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.
Detailed description
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.
Dosing will occur approximately 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.
After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects are randomized to receive one of four treatment sequences of four open-label treatments 48 hours apart.
| Arm | Type | Receives |
|---|---|---|
| ABDC | Experimental | Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups, Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseA: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose |
| BCAD | Experimental | Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups, Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseA: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose |
| CDBA | Experimental | Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups, Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseA: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose |
| DACB | Experimental | Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups, Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseA: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women or men 18 to 50 years of age (inclusive)
- Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count, blood chemistry, urinalysis, and ECG.
- Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening and admission/baseline visit.
- Consent of female subjects to use a medically effective method of contraception throughout the entire study period and for 30 days after the subject completes the study. Medically effective methods of contraception that may be used by the subject include abstinence, use of diaphragm and spermicide, intrauterine device (IUD), rings, condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation, hysteroscopic sterilization) and post-menopausal (≥ 2 years of amenorrhea).
- Ability to read, understand, and provide written informed consent that they understand the purpose of the study and procedures required for the study before enrolling in the study, and willingness to comply with all study procedures and restrictions.
Key exclusion criteria (35 listed)
- Evidence of significant history of hepatic, reproductive, gastrointestinal, renal, bleeding, or hematological disorders including coagulation, pulmonary, neurological, respiratory, endocrine, or cardiovascular system abnormalities (especially hypertension, peripheral vascular disease, coronary artery disease, transient ischemic attacks, or cardiac rhythm abnormalities), psychiatric disorders, acute infection, or other conditions that would interfere with study participation or with the absorption, distribution, metabolism, or excretion of drugs.
- Presence of three or more of the following CAD risk factors for cardiovascular disease:
- Any contraindication to zolmitriptan administration including:
- History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
- Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application sites from 2 weeks prior to dosing through their last day of study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches)Also: Treatment AM207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches | Drug | ABDC, BCAD, CDBA, DACB |
| M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups)Also: Treatment BM207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups | Drug | ABDC, BCAD, CDBA, DACB |
| M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cupsAlso: Treatment CM207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches | Drug | ABDC, BCAD, CDBA, DACB |
| Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single doseAlso: Treatment D, Zomig Nasal SprayZolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose | Drug | ABDC, BCAD, CDBA, DACB |
Primary outcome
Cmax
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
maximum observed plasma concentration
Adverse Events
Time frame: 48 hours
Subjects with treatment emergent adverse events
Tmax
Time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose
Time to maximum concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Kellerman, PharmD study director
Zosano Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) and M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups in people with Migraine, run by Zosano Pharma Corporation at 1 site 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?
The sponsor lists 5 inclusion and 35 exclusion criteria. 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Nov 2021). 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?
Cmax (time frame: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2021.