Actively Recruiting
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
Led by Sichuan Purity Pharmaceutical Technology Co., Ltd. · Updated on 2026-01-29
456
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18-75 years (inclusive)
- Body mass index (BMI) less than 35 kg/m8
- At least 1-year history of migraines (with or without aura) diagnosed according to the International Classification of Headache Disorder, 3rd Edition
- First migraine onset before age 50 years
- Migraine attacks lasting about 4-72 hours if untreated or treatment-resistant
- 2 to 8 moderate to severe migraine attacks per month within the last 3 months
- Fewer than 15 headache days (migraine or non-migraine) per month within the last 3 months
- Stable dose of prophylactic migraine medication for at least 3 months prior to screening, if applicable
- Chronic migraine patients with fewer than 15 headache days and 2 to 8 moderate to severe attacks per month due to stable preventive therapy may be included
- Able to understand and complete study questionnaires using an electronic patient-reported outcome application
You will not qualify if you...
- History of migraine with brainstem aura, retinal migraine, or hemiplegic migraine
- Poorly controlled, unstable, or recent cardiovascular or cardiometabolic disease, including ischemic heart disease, coronary vasospasm, cerebral ischemia within 6 months before screening, stroke, transient ischemic attack, myocardial infarction, acute coronary syndrome, cardiac surgery, or percutaneous coronary intervention
- Abnormal 12-lead ECG at screening
- Poorly controlled diabetes mellitus or hypertension
- Poorly controlled or severe peripheral vascular disease
- Any nasal structural abnormality, mucosal lesion, or disorder that could interfere with nasal drug absorption
- Taste disorders such as dysgeusia or hypogeusia
- Acute or chronic pain syndromes or other pain that may affect study assessments
- Regular use of ergotamine or triptans 10 or more days per month for 3 or more months
- Regular use of non-narcotic analgesics 15 or more days per month for 3 or more months
- Positive or clinically relevant abnormal hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody tests at screening
- History of alcohol or drug abuse within 1 year before screening or positive urine drug screen at screening
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Known allergy to the study drug or its ingredients, or history of significant allergic reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
Research Team
K
Ke Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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