Who is sponsoring NCT03555916?

NCT03555916 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT03555916?

Interventions in NCT03555916: BOTOX®, Allergan, Placebo.

What condition does NCT03555916 study?

NCT03555916 studies Trigeminal Neuropathy, Traumatic.

Is NCT03555916 still recruiting?

NCT03555916 is currently completed. Last updated 10 April 2023.

Last reviewed 2023-04-10 · How we verify

NCT03555916: TRIGTOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Botulinum Toxin Injections for Oral Neuropathic Pain

Completed Phase 3 Last updated 10 April 2023

What this trial tests

Phase 3 trial testing BOTOX®, Allergan in Trigeminal Neuropathy, Traumatic in 43 participants. Completed in 8 November 2022.

Timeline

4 April 2019

Primary endpoint
19 July 2022

8 November 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	43
Start date	4 April 2019
Primary completion	19 July 2022
Estimated completion	8 November 2022
Sites	1 location across France

Drugs / interventions tested

BOTOX®, Allergan — full drug profile →
Placebo

Conditions studied

Trigeminal Neuropathy, Traumatic — all drugs for Trigeminal Neuropathy, Traumatic →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 75, any sex, with Trigeminal Neuropathy, Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral painful traumatic trigeminal neuropathy (PPTTN) are poorly relieved by existing treatments which in addition induce many adverse effects. BTX, which blocks the exocytosis of neurotransmitters, can be captured by axonal retrograde transport in primary nociceptive neurons. Injected in the painful area, it might therefore inhibit the release of algogenic neurotransmitters, at both the peripheral and central levels and thus reduce pain. One study reported such an effect in neuropathic spinal pain. A recent study reported an analgesic effect in trigeminal neuralgia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03555916 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 10 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03555916.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing