A Phase 3 interventional study of M207 Microneedle System in Migraine, sponsored by Zosano Pharma Corporation. Completed at 31 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by Zosano Pharma Corporation · Phase 3, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 342 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Zosano Pharma Corporation is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Migraine history during the prior 6 months must include:
Main Exclusion Criteria:
Three or more of the following cardiovascular risk factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
Drug: M207 Microneedle System
M207 Microneedle System 3.8 mg
Also known as: ZP-Zolmitriptan Intracutaneous Microneedle System, ADAM-Zolmitriptan
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.
Time frame: 0 to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours for each Migraine, up to 12 months for each subject
| Milestone | M207 Microneedle System 3.8 mg |
|---|---|
| Started | 342 |
| Completed at least 6 months | 257 |
| Completed | 127 |
| Not completed | 215 |
| Withdrew: Exposure goals achieved | 60 |
| Withdrew: Non-compliance w/ protocol requirements | 79 |
| Withdrew: Adverse event | 15 |
| Withdrew: Lost to follow-up | 21 |
| Withdrew: Withdrawal by subject | 20 |
| Withdrew: Lack of efficacy | 12 |
| Withdrew: Sponsor decision | 3 |
| Withdrew: Physician decision | 2 |
| Withdrew: Pregnancy | 2 |
| Withdrew: Other | 1 |
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.
| Participants | M207 Microneedle System 3.8 mg |
|---|---|
| Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months | 323 |
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.
| Qualifying migraines with 2 hour data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose | 2477 |
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.
| Qualifying migraines with 2 hr data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose | 3315 |
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.
| Qualifying migraines with 2 hr data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose | 4552 |
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.
| Qualifying migraines with 2 hr data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose | 4628 |
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.
| Qualifying migraines with 2 hour data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose | 3410 |
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.
| Qualifying migraines with 2 hour data | M207 Microneedle System 3.8 mg |
|---|---|
| Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose | 3563 |
Collected over 0-12 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| M207 Microneedle System 3.8 mg | 0/335 (0%) | 5/335 (1.5%) | 323/335 (96.4%) |
| Event | M207 Microneedle System 3.8 mg |
|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 1/335 |
| Foetal disorderCongenital, familial and genetic disorders | 1/335 |
| Procedural painNervous system disorders | 1/335 |
| Breast cancer stage IIReproductive system and breast disorders | 1/335 |
| PneumoniaInfections and infestations | 1/335 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/335 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/335 |
| Event | M207 Microneedle System 3.8 mg |
|---|---|
| Application site erythemaSkin and subcutaneous tissue disorders | 316/335 |
| Application site swellingSkin and subcutaneous tissue disorders | 296/335 |
| Application site haemorrhageSkin and subcutaneous tissue disorders | 225/335 |
| Application site bruiseSkin and subcutaneous tissue disorders | 194/335 |
| Application site painSkin and subcutaneous tissue disorders | 81/335 |
| Application site discolourationSkin and subcutaneous tissue disorders | 53/335 |
| Application site pruritusSkin and subcutaneous tissue disorders | 52/335 |
| Upper respiratory tract infectionInfections and infestations | 28/335 |
| SinusitisInfections and infestations | 13/335 |
| NauseaGastrointestinal disorders | 9/335 |
Safety population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).
| Age, Continuous(years) | M207 Microneedle System 3.8 mg |
|---|---|
| Mean | 42.9 ± 12.07 |
| Sex: Female, Male(Participants) | M207 Microneedle System 3.8 mg |
|---|---|
| Female | 297 |
| Male | 38 |
| Ethnicity (NIH/OMB)(Participants) | M207 Microneedle System 3.8 mg |
|---|---|
| Hispanic or Latino | 60 |
| Not Hispanic or Latino | 275 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | M207 Microneedle System 3.8 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 55 |
| White | 265 |
| More than one race | 4 |
| Unknown or Not Reported | 3 |
| Height(cm) | M207 Microneedle System 3.8 mg |
|---|---|
| Mean | 165.20 ± 8.602 |
| Weight(kg) | M207 Microneedle System 3.8 mg |
|---|---|
| Mean | 79.76 ± 20.847 |
| BMI(kg/m^2) | M207 Microneedle System 3.8 mg |
|---|---|
| Mean | 29.19 ± 7.185 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in May 2019, 18 months.
Results were first posted in Aug 2020, 1 year 3 months after primary completion.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 18 months is close to that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Zosano Pharma Corporation