Efficacy and Safety of IONIS-PKKRx for Preventive Treatment of Chronic Migraine

• Status: Completed
• Trial end date: 2019-04-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and changes in the number of migraine and headache days with repeated subcutaneous administration of IONIS-PKKRx (ISIS 546254) or placebo in subjects with chronic migraine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Smith, Timothy R., M.D.
• Collaborators: Clinvest Research, LLC; Ionis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

Potential subjects must meet the following criteria at the screening visit to enter this study:

1. male or female, in otherwise good health, 18 to 65 years of age.

2. 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

3. onset of migraine before age 50.

4. stable pattern of migraine pattern for at least 3 months prior to screening.

5. 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:

1. unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.

2. pregnant, actively trying to become pregnant, or breast-feeding.

3. history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-3 beta criteria and/or MO during baseline period.

4. history of substance abuse and/or dependence, in the opinion of the Investigator.

5. unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.