Phase 2
Completed N=130
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Source: ClinicalTrials.gov NCT00384774 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug — 23; 2; 10; 11 Participants — p=1.0000
Summary
This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug |
23; 2; 10; 11; 10; 5 | 1.0000 |
| SECONDARY Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose |
11.9; 0; 8.3; 8.3; 14.3; 12.5 | — |
| SECONDARY Percentage of Participants Headache Free |
0; 0; 0; 0; 3.6; 0 | — |
| SECONDARY Number of Participants With Sustained Headache Response |
29; 2; 11; 16; 18; 7 | — |
| SECONDARY Number of Participants With Sustained Pain Free |
35; 4; 12; 21; 23; 13 | — |
| SECONDARY Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia |
7; 1; 5; 3; 6; 1 | — |
| SECONDARY Number of Participants With Clinical Disability |
11; 2; 1; 6; 9; 7 | — |
| SECONDARY Percentage of Participants Using Rescue Medication |
69.0; 25.0; 91.7; 58.3; 53.6; 37.5 | — |
| SECONDARY Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) |
9.5; 0; 0; 8.3; 25.0; 37.5 | — |
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 subjects aged 18 to 65 years
- Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner)
- Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache
- Able and willing to give written informed consent
Exclusion Criteria
- History of life threatening or intolerable adverse reaction to any triptan
- Use of prescription migraine prophylactic drugs
- 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)
- Sitting BP >160mmHg systolic or >90mmHg diastolic on 2 repeated measurements at screening
- 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 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
- 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
Data sourced from ClinicalTrials.gov (NCT00384774). 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.