Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine (NCT NCT03282227)
NCT ID: NCT03282227
Last Updated: 2020-08-19
Results Overview
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.
COMPLETED
PHASE3
342 participants
0 to 12 months
2020-08-19
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
342
|
|
Overall Study
Completed at Least 6 Months
|
257
|
|
Overall Study
COMPLETED
|
127
|
|
Overall Study
NOT COMPLETED
|
215
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Exposure Goals Achieved
|
60
|
|
Overall Study
Non-compliance w/ protocol requirements
|
79
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lost to Follow-up
|
21
|
|
Overall Study
Withdrawal by Subject
|
20
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Sponsor decision
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
M207 Microneedle System 3.8 mg
n=335 Participants
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 12.07 • n=99 Participants
|
|
Sex: Female, Male
Female
|
297 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
275 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
55 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
265 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Height
|
165.20 cm
STANDARD_DEVIATION 8.602 • n=99 Participants
|
|
Weight
|
79.76 kg
STANDARD_DEVIATION 20.847 • n=99 Participants
|
|
BMI
|
29.19 kg/m^2
STANDARD_DEVIATION 7.185 • n=99 Participants
|
PRIMARY outcome
Timeframe: 0 to 12 monthsPopulation: Safety Population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=335 Participants
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
|
323 Participants
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: 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.
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5617 Qualifying migraines with 2 hour data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose
|
2477 Qualifying migraines with 2 hour data
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: Modified Intent-to-Treat Population included all subjects who received
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5330 Qualifying migraines with 2 hr data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose
|
3315 Qualifying migraines with 2 hr data
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: 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.
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5617 Qualifying migraines with 2 hr data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose
|
4552 Qualifying migraines with 2 hr data
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: 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.
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5617 Qualifying migraines with 2 hr data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose
|
4628 Qualifying migraines with 2 hr data
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: 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.
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5617 Qualifying migraines with 2 hour data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose
|
3410 Qualifying migraines with 2 hour data
|
SECONDARY outcome
Timeframe: 2 hours for each Migraine, up to 12 months for each subjectPopulation: 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.
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.
Outcome measures
| Measure |
M207 Microneedle System 3.8 mg
n=5617 Qualifying migraines with 2 hour data
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose
|
3563 Qualifying migraines with 2 hour data
|
Adverse Events
M207 Microneedle System 3.8 mg
Serious adverse events
| Measure |
M207 Microneedle System 3.8 mg
n=335 participants at risk
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.30%
1/335 • 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.
|
|
Congenital, familial and genetic disorders
Foetal disorder
|
0.30%
1/335 • 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.
|
|
Nervous system disorders
Procedural pain
|
0.30%
1/335 • 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.
|
|
Reproductive system and breast disorders
Breast cancer stage II
|
0.30%
1/335 • 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.
|
|
Infections and infestations
Pneumonia
|
0.30%
1/335 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/335 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
1/335 • 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.
|
Other adverse events
| Measure |
M207 Microneedle System 3.8 mg
n=335 participants at risk
M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
M207 Microneedle System: M207 Microneedle System 3.8 mg
|
|---|---|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
94.3%
316/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site swelling
|
88.4%
296/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site haemorrhage
|
67.2%
225/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site bruise
|
57.9%
194/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site pain
|
24.2%
81/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site discolouration
|
15.8%
53/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
15.5%
52/335 • 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.
|
|
Skin and subcutaneous tissue disorders
Application site oedema
|
2.4%
8/335 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
28/335 • 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.
|
|
Infections and infestations
Sinusitis
|
3.9%
13/335 • 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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.1%
7/335 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
9/335 • 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.
|
Additional Information
Donald Kellerman, PharmD, Sr. VP, Clin Dev and Med Affairs
Zosano Pharma Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60