Migraine MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Interventions
Product Name: Ketorolac tromethamine
Product Code: ROX-828
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: ketorolac tromethamine
CAS Number: 74103-07-4
Current Sponsor code: ROX-828
Sponsors
ROXRO PHARMA, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male subjects aged 18 to 65 years. 2. Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1. 3. Onset of migraine prior to age 50 years. 4. Subjects who have between 2 and 8 moderate or severe migraine headaches per month. 5. Ability to communicate well with the study staff and to comply with the requirements of the entire study. 6. Subjects who read and understood the patient information sheet and have provided written informed consent to participate in this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Administration of any investigational drug up to 30 days before study entry or parallel participation in another study. 2. Subjects with more than 15 headache days per month. 3. Subjects with known allergy to, or known hypersensitivity to ketorolac, lidocaine, EDTA, or tromethamine. 4. Subjects with allergic manifestations to aspirin or other NSAIDs or with known history of sensitivity to local anesthetics of the amide type. 5. Patients currently receiving aspirin or NSAIDs. 6. Subjects who have at screening, as determined by the investigator, abnormal laboratory parameters in particular, liver or renal functions tests greater than twice the upper limit of normal. 7. Subjects with advance renal impairment or patients at risk for renal failure due to volume depletion. 8. Subjects with a history of a significant medical or psychiatric condition that may affect the safety of the subject or preclude adequate participation in the study. 9. Subjects with active peptic ulcer disease or a significant history of peptic ulcer disease or gastrointestinal bleeding. 10. Subjects with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and high risk of bleeding. 11. Subjects with a history within the last 2 years of abuse of alcohol or prescription or illicit drugs. 12. Subjects with any history of cocaine use. 13. Subjects who have ever used opiates regularly for any indication and any opiate use in the last 3 months. 14. Subjects who are pregnant or breast-feeding. Female subjects who are of child bearing potential must be using highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). 15. Subjects using migraine prophylaxis must have been on stable doses of the prophylactic agent for at least 12 weeks prior to study entry. 16. Known Hepatitis B or C or HIV infection. 17. Subjects who are employees of the sponsor. 18. Subjects who are employees or relatives of the investigator. 19. Subjects with bronchial asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of a single intranasal (IN) dose (2 insufflations) of ketorolac in the acute treatment of migraine. ;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of this dosing regimen.;Primary end point(s): The proportion of treated subjects who become pain free (IHS Grade 0) 2 hours after dosing. | — |
Countries
Finland, Germany
Outcome results
None listed