Migraine
Conditions
Brief summary
The purpose of this study is to learn about the efficacy and safety of PRT-064040 Nasal Spray versus placebo in the acute treatment of moderate or severe migraine.
Interventions
A single dose of PRT-064040 nasal spray
DRUGPlacebo
A single dose of placebo matched to PRT-064040 nasal spray
Sponsors
Sichuan Purity Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male and female participants aged 18-75 years (inclusive); 2. BMI \< 35 kg/m²; 3. Participant has at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition; 4. Age at first migraine onset \< 50 years; 5. Migraine attacks, on average, lasting about 4-72 hours if untreated or treatment-resistant; 6. 2-8 attacks of moderate to severe intensity per month within the last 3 months； 7. Less than 15 days with headache (migraine or non-migraine) per month within the last 3 months； 8. Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change until the EOT visit; 9. Patients diagnosed with chronic migraine who, owing to stable preventive therapy, have \< 15 headache days and 2-8 attacks of moderate to severe intensity per month in the 3 months before screening, and who meet all other entry criteria, may be enrolled; 10. Able to comprehend and complete study questionnaires with electronic patient-reported outcome (e-PRO) application.
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Freedom From Pain at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose | 2 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Pain Relief at 15 Minutes Post-dose | 15 minutes post-dose |
| Percentage of Participants With Pain Relief at 30 Minutes Post-dose | 30 minutes post-dose |
| Percentage of Participants With Pain Relief at 60 Minutes Post-dose | 60 minutes post-dose |
| Percentage of Participants With Pain Relief at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose |
| Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose | 30 minutes post-dose |
| Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose | 60 minutes post-dose |
| Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose | 2 hours post-dose |
| Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose | From 2 to 24 hours post-dose |
| Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose | From 2 to 48 hours post-dose |
| Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose | From 2 hours to 48 hours post-dose |
| Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose | Through 24 hours post-dose |
| Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose | 15 minutes post-dose |
| The incidence and severity of adverse events | Through 7(±2) days post-dose |
Countries
China
Contacts
CONTACTKe Yao
Outcome results
None listed