- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088632
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Jefferson Headache Center at Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.)
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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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Incobotulinumtoxina
Xeomin 25-100 units injected to chosen area one time.
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Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
Other Names:
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Placebo Comparator: Placebo Comparator
Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.
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Normal saline is sterile sodium chloride without and preservatives.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Number of Headache Attacks Reported in Active and Placebo Group
Time Frame: 84 days
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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.
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84 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Pain Intensity of Active and Placebo Group
Time Frame: 84 days
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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
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84 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen D Silberstein, MD, Thomas Jefferson University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Peripheral Nervous System Diseases
- Cranial Nerve Diseases
- Facial Nerve Diseases
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Neuralgia
- Trigeminal Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- incobotulinumtoxinA
Other Study ID Numbers
- XEO/SDS/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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