onabotulinum toxin A for Neuropathic Pain

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Orofacial Pain Center, Lexington, KY
Neuropathic Pain+1 More
onabotulinum toxin A - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain

See full description

Eligible Conditions

  • Neuropathic Pain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether onabotulinum toxin A will improve 1 primary outcome in patients with Neuropathic Pain. Measurement will happen over the course of Over 7 months.

Over 7 months
Pain Intensity

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

BOTOX
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Onabotulinum Toxin A is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

BOTOX
Drug
Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection. 1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C). Each patient will receive 50 U of onabotulinum toxin A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 7 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly over 7 months for reporting.

Closest Location

Orofacial Pain Center - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out.
Intractable pain to conventional oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants.
Subject consent to participate in the study.

Patient Q&A Section

Can neuralgia be cured?

"The use of anti-neurvitic medication in neuralgia is a questionable practice. Further studies are needed to determine whether neuralgia will return after anti-neurvitic treatment is stopped." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for neuralgia?

"The benefits of clinical trials for patients with sciatica are more likely to outweigh the risks when trials include low-risk patients from all age groups. Trials exclude older patients, women, certain ethnic groups, and patients who have undergone more than one surgery prior to commencement of the trial." - Anonymous Online Contributor

Unverified Answer

What is neuralgia?

"Neuralgia can be defined as persistent, long-term, localized pain of the skin or other soft tissues without a clear cause or identifiable neurological abnormality. Neuroma is defined as an acoustic feedback (sound) of nerve irritation that is often related to nerve compression in the neck (e.g., during head or spine surgery, during dental procedures, etc). Neuromas are a consequence of chronic pain. Nerve enlargement (an enlargement of an individual's nerve is defined as a 'neuroma') is the cause of chronic pain in the head and neck area, although it can occur in other areas, such as the arms." - Anonymous Online Contributor

Unverified Answer

What are the signs of neuralgia?

"Neuralgia pain is often referred in the dermatomal distribution for the trigeminal, posterior tibial, and ulnar sensory nerves. Pain in the distribution of the trigeminal nerve is most commonly seen in the head and neck overlying the ear, and usually in one or both eyes. There may be an associated burning pain that is constant and referral in the same dermatomal area with a painful trigeminal nerve distribution. Posterior tibial nerve pain may be intermittent or can be constant, and referral often occurs in a dermatomal area of distribution of the ulnar nerve, where there may be pain which is painful and that may run along the medial aspect of the hand." - Anonymous Online Contributor

Unverified Answer

What causes neuralgia?

"Neuropathic pain (due to peripheral nerves, spinal cord, or vagus nerve) accounts for approximately 80% of cases of chronic idiopathic neuropathic pain and is best treated with medications. Pharmacological options include anticonvulsants, anti-depressants, opioid analgesics, and antiepileptic medications, which can relieve or eliminate pain. Surgery can improve symptoms as well as improve quality of life and may be used as a last resort. The neuralgia headache and neuralgic amyotrophy are classified as somatic sensory disorders." - Anonymous Online Contributor

Unverified Answer

How many people get neuralgia a year in the United States?

"A number of risk factors for the development of neuropathic pain in individuals with diabetes have been identified. These factors appear to act synergistically to increase the risk, and may be treated to significantly reduce the burden of pain." - Anonymous Online Contributor

Unverified Answer

What are common treatments for neuralgia?

"While there are no effective treatments for nerve entrapment neuropathies, such as spinal cord compression, peripheral nerve entrapment may be managed with conservative treatment (including pain medication and physical therapy) and the use of splints. Surgery is often recommended only for those with intractable or disabling symptoms and can often be performed in conjunction with other treatments. A Cochrane review found no high quality evidence for the use of neuromodulating agents (i.e. implantable and non-implanted neural stimulators) to treat neuralgia. Although the evidence for the use of botulinum toxin type A for the management of neuropathic pain is limited, this method of managing symptomatic pain is becoming popular in the U." - Anonymous Online Contributor

Unverified Answer

Does onabotulinum toxin a improve quality of life for those with neuralgia?

"Onabotulinum toxin A significantly improved patients' distress/pain and overall functioning, as determined by the SF-36. A substantial percentage of patients with neuralgia also experienced excellent cosmetic and functional outcomes." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating neuralgia?

"No treatment alternative has been validated as effective in relieving all (or any) of the reported symptoms of postherpetic neuralgia. There has been no further evidence discovered of any treatments that can help people whose condition is severe enough to result in a disability. There is no reason to believe that advances in any area of medicine would help people who are already desperate and in need." - Anonymous Online Contributor

Unverified Answer

How serious can neuralgia be?

"Some factors may determine the severity of neuralgia, including the nature and the location of a problem; some people do not develop severe pain and can be managed medically, but others experience severe pain as a secondary consequence of other medical problems." - Anonymous Online Contributor

Unverified Answer

Does neuralgia run in families?

"The prevalence of neuropathy and neuralgia are 2-3-fold higher in families of patients with multiple neuropathies and neuropathies than in the general population. These data support the hypothesis that some form of familial genetic factors predispose to neuropathy and neuralgia. The specific genetic or molecular lesion underlying this susceptibility remains unidentified." - Anonymous Online Contributor

Unverified Answer

What is onabotulinum toxin a?

"• [Onabotulinum toxin A injection is a good therapy for postherpetic neuralgia. • The optimal target to target injection is yet to confirmed and more studies need to be conducted. • There are less side effects associated with abobotulinum toxin than botulinum toxin A. • The clinical efficacy is comparable with abobotulinum toxin A and botulinum toxin A." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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