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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 is a Phase 2 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 6 participants.
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.
Interventions
- OTHER Placebo Comparator
- BIOLOGICAL Incobotulinumtoxina
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-03-14 |
| Est. Completion | 2016-10-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02088632
The ClinicalTrials.gov registry entry for NCT02088632 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT02088632 reports 0 study locations.
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.
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