CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
IONIS-PKKRx (ISIS 546254) +1 moredrug
Likely dose
IONIS-PKKRx (ISIS 546254) 1.00 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03108469
NCT03108469Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ISIS 546254 for Preventive Treatment of Chronic Migraine

Smith, Timothy R., M.D.·interventional·Posted Apr 11, 2017·Updated Feb 12, 2020

In Brief

A Phase 2 clinical trial evaluating IONIS-PKKRx (ISIS 546254) and Placebo for Chronic Migraine. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Migraine
CountriesUnited States
CollaboratorsClinvest Research, LLC, Ionis Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartAug 1, 2017
Primary CompletionApr 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.2 years ago

Interventions

IONIS-PKKRx (ISIS 546254)drug

Those randomized to IONIS-PKKRx (ISIS 546254) will receive subcutaneous injections containing 1.00 mL (200mg) of IONIS- PKKRx (ISIS 546254) weekly for weeks 1-16.

Placeboother

Those randomized to placebo will receive subcutaneous injections 1.00 mL (200mg) weekly for weeks 1-16.