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 | PT |
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 |
To evaluate the efficacy (headache response at two hours) of a range of oral doses of COL-144 in order to select a dose or doses for further evaluation. |
|
E.2.2 | Secondary objectives of the trial |
Secondary Objective: 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, vomiting, disability, use of rescue medication and patient global impression.
Safety Objective: To explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible for the study if all of the following criteria are met: 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 patients aged 18 to 65 years 6. Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner) 7. Able and willing to give written informed consent 8. Able and willing to complete a migraine diary card to record details of the attack treated with study medication |
|
E.4 | Principal exclusion criteria |
Patients are excluded from the study if any of the following criteria are met: 1. History of life threatening or intolerable adverse reaction to any triptan 2. Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation 3. Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis 4. Using 5-HT reuptake inhibitors 5. Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details) 6. Pregnant or breast-feeding women 7. Women of child-bearing potential not using highly effective contraception 8. History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures 9. History or current hypertension (controlled or uncontrolled) 10. History of orthostatic hypotension with syncope 11. Current use of hemodynamically active cardiovascular drugs 12. History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol 13. Significant renal or hepatic impairment 14. Previous participation in this clinical trial 15. Participation in any clinical trial of an experimental drug or device in the previous 30 days 16. Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study 17. Known Hepatitis B or C or HIV infection 18. Patients who are employees of the sponsor 19. Relatives of, or staff directly reporting to, the investigator 20. Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product 21. Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded) |
|
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 two hours after intake of study drug.
Secondary endpoints are: ? Headache free (absence of headache) two hours after intake of study drug ? Headache severity (4 point scale: none, mild, moderate, severe) ? Headache recurrence within 24 hours ? Presence or absence of nausea, phonophobia, photophobia, vomiting ? Disability (4 point scale: not at all, mild interference, marked interference, completely ? needs bed rest) ? Requirement for rescue medication between 2 and 24 hours (yes or no) ? Patient global impression (7 point scale) ? Time to headache relief and time to pain free
The primary safety endpoints of this study are: ? Adverse events (spontaneously reported) ? 12-Lead electrocardiograms (ECGs) ? Vital signs ? Clinical laboratory parameters ? Physical examination |
|
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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 study will end on the date that the final patient completes the post-treatment follow-up visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |