A Study of LY2951742 for Patients with Episodic Cluster Headaches

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 16-008880
    NCT ID: NCT02397473
    Sponsor Protocol Number: I5Q-MC-CGAL

About this study

The main purpose of this study is to evaluate the effectiveness and safety of the study drug known as LY2951742 for the treatment of patients who have episodic cluster headaches.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • A history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of ≥1 month
  • Able to distinguish cluster headache attacks from other headaches

Exclusion Criteria

  • Current enrollment in or discontinuation within the last 30 days from a clinical trial involving any investigational drug or device
  • Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF)
  • Is taking indomethacin and/or suspected of having another distinct trigeminal autonomic cephalalgia
  • A history of migraine variants that could implicate or could be confused with ischemia
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins
  • A history or presence of other medical illness that indicates a medical problem that would preclude study participation
  • Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator
  • Pregnant or nursing

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Todd Rozen, M.D.

Closed for enrollment

Contact information:

Sabrina Selman C.C.R.C.

(904)953-3062

Selman.Sabrina@mayo.edu

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CLS-20310180

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