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

NCT03108469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-12

Study results available
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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.

Conditions

  • Chronic Migraine

Interventions

DRUG

IONIS-PKKRx (ISIS 546254)

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • Clinvest Research, LLC

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Smith, Timothy R., M.D.

    lead INDIV

Principal Investigators

  • Timothy R Smith, MD · Clinvest Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-04-26
Completion
2019-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108469 on ClinicalTrials.gov