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COMPLETED Phase 3

A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

NCT04530110 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab. The total duration of the study is planned to be up to 84 months.

Conditions Studied

Interventions

  • DRUG Fremanezumab

Study Locations (20)

Florida

  • Teva Investigational Site 14244 — Jacksonville
  • Teva Investigational Site 14325 — Miami
  • Teva Investigational Site 14250 — West Palm Beach
  • Teva Investigational Site 14255 — West Palm Beach

Colorado

  • Teva Investigational Site 14319 — Aurora
  • Teva Investigational Site 14368 — Colorado Springs

Georgia

  • Teva Investigational Site 14243 — Atlanta
  • Teva Investigational Site 14258 — Savannah

Illinois

  • Teva Investigational Site 14263 — Hoffman Estates

Kansas

  • Teva Investigational Site 14245 — Wichita

Kentucky

  • Teva Investigational Site 14327 — Louisville

Louisiana

  • Teva Investigational Site 14360 — Covington

Maryland

  • Teva Investigational Site 14365 — Baltimore

Trial Details

FieldValue
Enrollment Target 506 participants
Start Date 2020-09-16
Est. Completion 2025-12-22
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04530110

The ClinicalTrials.gov registry entry for NCT04530110 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 1 intervention — of which Fremanezumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04530110 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04530110 about?

NCT04530110 is a clinical study titled "A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents". The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the effica...

What is the current status of trial NCT04530110?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2020-09-16. Estimated completion is 2025-12-22.

What conditions does trial NCT04530110 study?

This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04530110?

The interventions under investigation include: Fremanezumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04530110?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04530110 being conducted?

This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial