E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
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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 |
To evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation. |
|
E.2.2 | Secondary objectives of the trial |
To explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including; headache response, proportion of patients pain free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication and patient global impression. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004) 2. History of migraine of at least 1 year 3. Migraine onset before the age of 50 years 4. History of 1 – 8 migraine attacks per month 5. Male or female subjects aged 18 to 65 years 6. Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner) 7. Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache 8. Able and willing to give written informed consent |
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E.4 | Principal exclusion criteria |
1. History of life threatening or intolerable adverse reaction to any triptan 2. Use of prescription migraine prophylactic drugs 3. Pregnant or breast-feeding women 4. Women of child-bearing potential not using highly effective contraception 5. History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures 6. History of hypertension (controlled or uncontrolled) 7. Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at screening 8. Current use of hemodynamically active cardiovascular drugs 9. History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol 10. Significant renal impairment 11. Previous participation in this clinical trial 12. Participation in any clinical trial of an experimental drug or device in the previous 30 days 13. Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study 14. Relatives of, or staff directly reporting to, the investigator 15. Patients with known hypersensivity to COL-144, other 5HT1F Receptor Agonists or to any excipient of COL-144 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is headache response, defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Secondary endpoints are: - rates of headache response as defined above at 10min, 20min, 40min, 60min, 90min, 180min, and 240min after initiation of study drug - proportion of patients headache free at 10min, 20min, 40min, 60min, 90min, 120min, 180min, and 240min after initiation of study drug - rates of sustained response, defined as a moderate or severe headache at baseline which became mild or no headache by 2 hours after initiation of study drug and which did not recur (become moderate or severe) within 24 hours of initiation of study drug or use of rescue medication within 24 hours of initiation of study drug - rates of sustained pain free, defined as a moderate or severe headache at baseline which became no headache by 2 hours after initiation of study drug and which did not recur (become mild, moderate or severe) within 24 hours of initiation of study drug or use of rescue medication within 24 hours of initiation of study drug - relief of nausea, vomiting, photophobia, and phonophobia - degree of clinical disability - proportion of patients using rescue medication between 2 and 24 hours after study drug - patient global impression (seven point scale)
The primary safety endpoints of this study are: - Adverse events - 12-Lead electrocardiogram (ECG) - Vital signs - Clinical chemistry, hematology, and urinalysis - Physical examination |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 on the date that the final patient completes the post-treatment follow-up visit. |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |