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COMPLETED Phase 3

A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

NCT04458857 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab. The total duration of the study is planned to be up to 51 months.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Fremanezumab

Study Locations (20)

California

  • Teva Investigational Site 14253 — Banning
  • Teva Investigational Site 14370 — Loma Linda
  • Teva Investigational Site 14322 — Los Angeles
  • Teva Investigational Site 14361 — Sacramento

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
  • Teva Investigational Site 14283 — Park Ridge

Maryland

  • Teva Investigational Site 14365 — Baltimore
  • Teva Investigational Site 14317 — Silver Spring

Arkansas

  • Teva Investigational Site 14281 — Little Rock

Kansas

  • Teva Investigational Site 14245 — Wichita

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2020-07-15
Est. Completion 2024-03-13
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04458857

The ClinicalTrials.gov registry entry for NCT04458857 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 235 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 2 interventions — of which Placebo 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: NCT04458857 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Colorado. 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 NCT04458857 about?

NCT04458857 is a clinical study titled "A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age". The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to ev...

What is the current status of trial NCT04458857?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2020-07-15. Estimated completion is 2024-03-13.

What conditions does trial NCT04458857 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 NCT04458857?

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

Who is sponsoring clinical trial NCT04458857?

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 NCT04458857 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. 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