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COMPLETED Phase 4

Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

NCT02191579 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Conditions Studied

Interventions

  • DRUG Topiramate
  • BIOLOGICAL onabotulinumtoxinA

Study Locations (20)

Florida

  • Parkinson's Disease and Movement Disorders Center of Boca Raton Inc — Boca Raton
  • Design Neuroscience Center — Doral
  • NW FL Clinical Research Group, LLC — Gulf Breeze
  • Negroski, Sutherland & Hanes Neurology — Sarasota
  • Neurology Research Institute at Palm Beach Neurology — West Palm Beach

California

  • North County Neurology Associates — Encinitas
  • California Headache and Balance Center — Fresno
  • Newport Beach Clinical Research Associates, Inc. — Newport Beach

Kansas

  • International Clinical Research Institute Inc — Overland Park
  • Kansas City Bone and Joint Clinic — Overland Park

Massachusetts

  • MedVadis Research Corporation — Watertown
  • New England Regional Headache Center Inc — Worcester

Missouri

  • Clinvest — Springfield
  • Mercy Health Research — St Louis

Arizona

  • St Joseph's Hospital Barrow Neurology Clinics — Phoenix

Colorado

  • Denver Neurological Clinic — Denver

Connecticut

  • Ki Health Partners LLC DBA New England Institute for Neurology and Headache — Stamford

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2014-08-05
Est. Completion 2017-09-01
Phase Phase 4

Sponsor

Allergan

52 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02191579

The ClinicalTrials.gov registry entry for NCT02191579 describes a study currently listed as completed. It is categorized as Phase 4, 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 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 52 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 Disorders appearing as the primary indexed condition, and to 2 interventions — of which Topiramate 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: NCT02191579 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Kansas. 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 NCT02191579 about?

NCT02191579 is a clinical study titled "Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults". This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

What is the current status of trial NCT02191579?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 282 participants. The study started on 2014-08-05. Estimated completion is 2017-09-01.

What conditions does trial NCT02191579 study?

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

What interventions are being tested in trial NCT02191579?

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

Who is sponsoring clinical trial NCT02191579?

This trial is sponsored by Allergan, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02191579 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. 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