Phase 2
Completed N=512
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Migraine Disorders
Source: ClinicalTrials.gov NCT00883051 ↗
Enrolled (actual)
512
Serious AEs
0.3%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants With Headache Response — 57.0; 35.8; 49.3; 35.3 percentage of participants — p=<0.0001
Summary
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Headache Response |
57.0; 35.8; 49.3; 35.3; 74.1; 43.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose |
13.9; 13.6; 18.8; 27.9; 7.4 | =0.0006 sig |
| SECONDARY Percentage of Participants With Headache Recurrence |
55.9; 57.7; 62.9; 50.0; 57.1 | — |
| SECONDARY Percentage of Participants With Headache Severity (4 Point Rating Scale) |
13.9; 13.6; 18.8; 27.9; 7.4; 29.1 | — |
| SECONDARY Percentage of Participants Who Have Symptoms of Nausea |
31.65; 25.00; 35.29; 26.87; 40.74 | — |
| SECONDARY Percentage of Participants Who Have Symptoms Phonophobia |
41.77; 23.75; 39.71; 31.34; 48.15 | — |
| SECONDARY Percentage of Participants Who Have Photophobia |
46.84; 31.25; 41.18; 37.31; 65.43 | — |
| SECONDARY Percentage of Participants With Vomiting |
5.06; 0.00; 7.35; 4.80; 11.11 | — |
| SECONDARY Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest) |
13; 14; 12; 10; 6; 26 | — |
| SECONDARY Percentage of Participants Who Used Rescue Medication |
54.5; 51.9; 61.2; 41.8; 68.8 | — |
| SECONDARY Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I) |
3; 2; 3; 4; 3; 15 | — |
| SECONDARY Actual Time to Headache Relief and Time to Pain Free |
650.87; 291.05; 407.16; 218.93; 760.15; 871.27 | — |
| SECONDARY Change From Baseline in Heart Rate |
2.0; 3.0; 1.0; 2.0; 1.0 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
1.0; 0.0; -1.5; -0.5; -0.0 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Physical Examination Parameters |
1.2; 2.4; 1.4; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Hematology Tests |
0.0; 0.0; 0.1; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Serious Adverse Events |
0; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
- History of migraine of at least 1 year
- Migraine onset before the age of 50 years
- History of 1 - 8 migraine attacks per month
- Male or female patients aged 18 to 65 years
- Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
- Able and willing to give written informed consent
- Able and willing to complete a migraine diary card to record details of the attack treated with study medication
Exclusion Criteria
- History of life threatening or intolerable adverse reaction to any triptan
- Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
- Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
- Using 5-HT reuptake inhibitors
- Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
- Pregnant or breast-feeding women
- Women of child-bearing potential not using highly effective contraception
- History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
- History of hypertension (controlled or uncontrolled)
- History of orthostatic hypotension
- Current use of hemodynamically active cardiovascular drugs
- History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
- Significant renal or hepatic impairment
- Previous participation in this clinical trial
- Participation in any clinical trial of an experimental drug or device in the previous 30 days
- Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
- Known Hepatitis B or C or HIV infection
- Patients who are employees of the sponsor
- Relatives of, or staff directly reporting to, the investigator
- Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
- Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Data sourced from ClinicalTrials.gov (NCT00883051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.