At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 44 enrolled

Drug / intervention

onabotulinumtoxinAdrug

Likely dose

onabotulinumtoxinA 5 unitsfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02037425

NCT02037425Phase 4Completed

Compare CT.gov

Exploratory Study of the Natural History, Clinical Outcomes, and Neuronal Endplate Changes in Subjects Reporting Short Duration vs. Long Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

Cady, Roger, M.D.·interventional·Posted Jan 16, 2014·Updated Aug 11, 2016

In Brief

A Phase 4 clinical trial evaluating onabotulinumtoxinA for Chronic Migraine. Completed, enrolled 44 participants across 1 site.

Detailed Summary

To obtain a patient specific understanding of response to treatment with onabotulinumtoxinA by collecting and correlating pre and post treatment subject specific history, clinical outcomes, and histological changes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Migraine

CountriesUnited States

CollaboratorsAllergan

Timeline

Phase 4CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedJan 2014

Enrollment StartApr 2014

Primary CompletionSep 2015

TodayJul 2026

First PostedJan 16, 2014

Enrollment StartApr 1, 2014

Primary CompletionSep 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 12.5 years ago

Interventions

onabotulinumtoxinAdrug

BOTOX® (Formulation Number 9060X) contains 200 International Units (IU) of Clostridium botulinum Toxin Type A, reconstituted with 4 cc of normal saline providing 5 units per 0.1 cc. At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).