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NCT02088632 · ClinicalTrials.gov registry record · Phase 2

Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

A Phase 2 study, sponsored by Thomas Jefferson University.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT02088632: Clinical Trial Phase 2 study, sponsored by Thomas Jefferson University.

NCT02088632 is a Phase 2 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02088632, a Phase 2 study, was terminated before completion, sponsored by Thomas Jefferson University.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from motor neurons. In addition it blocks the release of Substance P (SP) and Calcitonin Gene Related Peptide (CGRP) from C fibers involved in pain perception. This study is designed to see if Xeomin® is superior to placebo in the treatment of medically refractory trigeminal neuralgia (TN). Subjects will be asked to maintain an attack diary throughout the study. They will also be asked to attend 4 office visits; Visit 1- Screening Visit, Visit 2- Injection Visit, Visit 3- Follow-Up Visit and Visit 4- Final Visit. At the end of the study the active (Xeomin®) and placebo groups will be compared to see if one group had better relief than the other.

Primary Outcome

Mean daily number of attacks during baseline period (30 days) will be compared to mean daily number of attacks for baseline and 84 days as recorded in patient diary.

Interventions

  • OTHER Placebo Comparator
  • BIOLOGICAL Incobotulinumtoxina

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2014-03-14
Est. Completion 2016-10-19
Phase Phase 2
Thomas Jefferson University

292 total trials

Why NCT02088632 stopped before completion

NCT02088632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.

NCT02088632 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02088632 about?

NCT02088632 is a clinical study titled "Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia". IncobotulinumtoxinA (Xeomin®) is a neurotoxin which inhibits the release of certain chemicals at the nerve terminals. It blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from motor neurons. In addition it blocks the release of Substance P (SP) ...

What is the current status of trial NCT02088632?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2014-03-14. Estimated completion is 2016-10-19.

What interventions are being tested in trial NCT02088632?

The interventions under investigation include: Placebo Comparator (OTHER), Incobotulinumtoxina (BIOLOGICAL).

Who is sponsoring clinical trial NCT02088632?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02088632's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02088632, the US trial registry maintained by the National Library of Medicine. NCT02088632 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.