Estudio doble ciego, aleatorizado y controlado con placebo con grupos paralelos para determinación de dosis de COL-144 por vía oral en el tratamiento agudo de la migraña
- Conditions
- MigrañaMedDRA version: 9.1Level: PTClassification code 10027599Term: Migraine
- Registration Number
- EUCTR2008-005010-43-ES
- Lead Sponsor
- CoLucid Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method