NCT04578782

Efficacy of OnabotulinumtoxinA in Migraine

Completed Phase 2 Last updated 8 October 2020

What this trial tests

Phase 2 trial testing OnabotulinumtoxinA in Migraine in 32 participants. Completed in 31 May 2020.

Timeline

13 March 2018

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	IRCCS National Neurological Institute "C. Mondino" Foundation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	13 March 2018
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across Italy

Drugs / interventions tested

• OnabotulinumtoxinA (ONABOTULINUMTOXINA) — full drug profile →

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Who can join

Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year.

CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM.

At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis.

The aim of the present study was to evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm.
   Martinelli D, Arceri S, De Icco R, Allena M, et al · · 2022 · cited 9× · PMID 34404257 · DOI 10.1177/03331024211034508
2. The International Headache Congress - IHS and EHF joint congress 2021 : Virtual. 8-12 September 2021.
   · 2021 · cited 4× · PMID 34488620 · DOI 10.1186/s10194-021-01293-9