Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine
Source: ClinicalTrials.gov NCT03108469 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migraine Days |
14.267; 14.133; 11.067; 9.867 | — |
| SECONDARY Headache Severity |
1.605; 1.538; 1.202; 0.994 | — |
| SECONDARY Headache Days |
22.267; 23.733; 17.733; 14.333 | — |
| SECONDARY Number of Subjects Reporting a ≥ 50% Reduction in the Number of Migraine Headaches |
2; 6 | — |
| SECONDARY Count of Migraine Headache Days Requiring Use of Migraine Medication |
7.2; 14.733; 4.733; 7.733 | — |
| SECONDARY Migraine Specific Quality of Life (MSQ) Questionnaire Score |
50.133; 50.133; 41.133; 40.733 | — |
| SECONDARY Physician Global Impress of Change (PGIC) Score |
0.867; 1.00 | — |
| SECONDARY Subject Global Impress of Change (SGIC) Score |
0.867; 1.13 | — |
Eligibility Criteria
Inclusion Criteria
Potential subjects must meet the following criteria at the screening visit to enter this study:
- male or female, in otherwise good health, 18 to 65 years of age.
- history of chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013), as follows:
a. History of frequent headaches suggestive of chronic migraine (15 or greater days of qualifying headaches per month) for at least three months prior to screening b. Verification of headache frequency through prospectively collected baseline information during the 28-day run-in phase demonstrating headaches on at least 15 days, with at least 8 days per month fulfilling any ONE of the following; i. Qualify as being a migraine attack ii. Relieved by migraine specific acute medications
- onset of migraine before age 50.
- stable pattern of migraine pattern for at least 3 months prior to screening.
- not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
i. Subjects on migraine preventative should have stable headache pattern ii. Injections of onabotulinumtoxinA are allowable if subject has completed at least 2 injection cycles and agrees to maintain a regular injection cycle for the duration of the study
Exclusion Criteria
Potential subjects meeting any of the following criteria will be excluded from entering this study:
- unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
- pregnant, actively trying to become pregnant, or breast-feeding.
- history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-3 beta criteria and/or MO during baseline period.
- history of substance abuse and/or dependence, in the opinion of the Investigator.
- unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
Data sourced from ClinicalTrials.gov (NCT03108469). 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.