Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

NCT02088632 | Terminated Phase 2 Results

• 1 other identifier: XEO/SDS/01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in Mean Number of Headache Attacks Reported in Active and Placebo Group

  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.

  84 days

Secondary Outcomes (1)

• Change in Mean Pain Intensity of Active and Placebo Group

  84 days

Study Arms (2)

Incobotulinumtoxina

ACTIVE COMPARATOR

Xeomin 25-100 units injected to chosen area one time.

Biological: Incobotulinumtoxina

Placebo Comparator

PLACEBO COMPARATOR

Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.

Other: Placebo Comparator

Interventions

Incobotulinumtoxina BIOLOGICAL

Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.

Also known as: Xeomin

Incobotulinumtoxina

Placebo Comparator OTHER

Normal saline is sterile sodium chloride without and preservatives.

Also known as: Normal Saline, sodium chloride, placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 75 yrs
• Male or non-pregnant/non-lactating female
• Subjects must have a mean attack frequency of at least 3 episodes/day of 4/10 pain
• Use of adequate birth-control measures as determined by investigator for females of child-bearing potential
• Diagnosis of Classical trigeminal neuralgia (TN) using International Classification of Headache Disorders (ICHD-2) criteria (see Appendix A in Protocol)
• Subjects have given written informed consent prior to entering study
• Subjects on a stable dose of concomitant preventive medications for treatment of TN for at least 4 weeks prior to study entry and throughout the 12 week observation period
• Subjects who require "rescue" analgesic medication during the study will be allowed to use their current (pre-study) opioid and/or non opioid analgesics as clinically indicated (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, cyclooxygenase-2 (COX-2) inhibitors, topical analgesics).
• Subjects will be prohibited from initiating any therapy with a new preventive medication throughout the remainder of the study.
• Subject must be willing and able to abstain from initiating an alternative therapy (e.g., acupuncture, massage or physical therapy) for pain relief during the study.
• (NOTE: subjects who are currently using alternative therapy for pain relief can be enrolled if they are willing and able to maintain such therapy stable throughout the study.)

You may not qualify if:

• Symptomatic TN
• Serious hepatic, respiratory, hematologic, cardiovascular or renal condition
• Neurologic pain other than TN, with the exception of occasional migraine or tension-type headaches. (\<4 headaches per month; \< 10 headache days/month)
• Psychiatric or medical condition that might compromise participation in study, as determined by the investigator
• Administration of any investigational drug within 30 days prior to screening
• History of substance abuse/alcoholism

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

Jefferson Headache Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

incobotulinumtoxinA; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Very slow enrollment and low number of participants limited study. Study was terminated prior to analysis. The data was highly skewed.

Results Point of Contact

• Title: Clinical research manager
• Organization: Jefferson Headache Center

mary.hopkins@jefferson.edu

2159552680

Study Officials

• Stephen D Silberstein, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 17, 2014
• Study Start: March 14, 2014
• Primary Completion: June 11, 2015
• Study Completion: October 19, 2016
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Locations

US (1)