E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the efficacy of a single intranasal (IN) dose (2 insufflations) of ketorolac in the acute treatment of migraine. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety and tolerability of this dosing regimen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of treated subjects who become pain free (IHS Grade 0) 2 hours after dosing. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is defined as the last visit of the last patient undergoing the trial (protocol section 9.5.4.4). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |