Trigeminal NeuralgiaPhase 2NCT02088632
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
A Phase 2 study testing Incobotulinumtoxina in people with Trigeminal Neuralgia, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Incobotulinumtoxina
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2014to 19 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.)
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in 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) 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.
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Incobotulinumtoxina, Placebo Comparator
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinaBiological
Also called Xeomin
Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
Placebo ComparatorOther
Also called Normal Saline, sodium chloride, placebo
Normal saline is sterile sodium chloride without and preservatives.
| Study group | Role | What they receive |
|---|---|---|
| Incobotulinumtoxina | Active comparator | Xeomin 25-100 units injected to chosen area one time. Receives: Biological: Incobotulinumtoxina |
| Placebo Comparator | Placebo comparator | Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time. Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
Secondary outcomes (1)
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
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start14 Mar 2014
- Primary completion11 Jun 2015
- Study completion19 Oct 2016
Why it stopped: Unable to enrolled in a timely manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen D Silberstein, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088632
- Sponsor's protocol ID
- XEO/SDS/01
- Status last verified
- Jun 2023
- First submitted
- 4 Mar 2014
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Add-on Therapy Study of Xeomin (Incobotulinumtoxina) Versus Placebo in the Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT02088632
- Acronym / sponsor ID
- XEO/SDS/01
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enrolled in a timely manner.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 11 Jun 2015 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incobotulinumtoxina | Active comparator | Biological: IncobotulinumtoxinaXeomin 25-100 units injected to chosen area one time. |
| Placebo Comparator | Placebo comparator | Other: Placebo ComparatorPlacebo Comparator is 1-2 ml normal saline solution injected to chosen area one time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinaAlso: XeominIncobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection. | Biological | Incobotulinumtoxina |
| Placebo ComparatorAlso: Normal Saline, sodium chloride, placeboNormal saline is sterile sodium chloride without and preservatives. | Other | Placebo Comparator |
Primary outcome
Change in Mean Number of Headache Attacks Reported in Active and Placebo Group
Time frame: 84 days
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.
1 secondary outcome
Change in Mean Pain Intensity of Active and Placebo Group
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Silberstein, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incobotulinumtoxina in people with Trigeminal Neuralgia, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Number of Headache Attacks Reported in Active and Placebo Group (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.