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Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Incobotulinumtoxina

Placebo Comparator

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Inclusion Criteria

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.)

Exclusion Criteria:Exclusion Criteria

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

Sites / Locations

Jefferson Headache Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Incobotulinumtoxina

Placebo Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Mean Pain Intensity of Active and Placebo Group

Mean of the daily pain intensity as measured on a 0-10 pain scale where 0 = no pain and 10 is the worst pain reported on paper diary from baseline and 84 days

Full Information

NCT ID

NCT02088632

First Posted

March 4, 2014

Last Updated

June 9, 2023

Sponsor

Thomas Jefferson University

Collaborators

Merz North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02088632

Brief Title

Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Unable to enrolled in a timely manner.

Study Start Date

March 14, 2014 (Actual)

Primary Completion Date

June 11, 2015 (Actual)

Study Completion Date

October 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

Merz North America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a randomized, double-blind, placebo-controlled, add-on therapy study. Up to 70 eligible subjects with medically refractory TN will be screened to enroll forty subjects; twenty will be randomized to the active medication group IncobotulinumtoxinA (Xeomin) and twenty to the placebo group (0.9% Normal Saline Solution). Using a daily diary, all subjects will document their overall pain level and attack frequency and intensity for four weeks. After the four week baseline period, subjects will undergo initial injections (IncobotulinumtoxinA [Xeomin] or placebo). Subjects will remain on a consistent dose of their previously prescribed medications throughout the study. The primary outcome will be the difference in decrease in mean number of attacks of at least 4/10 intensity between the active and placebo groups. Secondary outcome measures will be frequency and average intensity of daily pain attacks. Subject Global Assessment, Beck Depression Inventory II (BDI-II), Short Form-36 (SF-36) Health Surveys, and visual analog scale (VAS), will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Incobotulinumtoxina

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Incobotulinumtoxina

Other Intervention Name(s)

Xeomin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo Comparator

Other Intervention Name(s)

Normal Saline, sodium chloride, placebo

Intervention Description

Normal saline is sterile sodium chloride without and preservatives.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

84 days

Secondary Outcome Measure Information:

Title

Change in Mean Pain Intensity of Active and Placebo Group

Description

Mean of the daily pain intensity as measured on a 0-10 pain scale where 0 = no pain and 10 is the worst pain reported on paper diary from baseline and 84 days

Time Frame

84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:Inclusion Criteria 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.) - Exclusion Criteria:Exclusion Criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen D Silberstein, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jefferson Headache Center at Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

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Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

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