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Neurotoxin

Botox for Neuropathic Pain

Phase 2

Recruiting

Research Sponsored by Isabel Moreno Hay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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.

Must not have

Bleeding disorders

Systemic nerve or muscle disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 7 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether intraoral administration of BoNT-A can help relieve continuous neuropathic pain.

Who is the study for?

This trial is for individuals with ongoing dentoalveolar pain that hasn't improved with standard oral or topical medications. Participants must have signs of trigeminal nerve dysfunction and no other sources of pain, not be allergic to Botox components, have no systemic nerve/muscle disorders, bleeding issues, swallowing/breathing difficulties, and not be pregnant or breastfeeding.

What is being tested?

The study tests the effect of injecting 50 units of onabotulinum toxin A (Botox) into areas affected by neuropathic pain in the mouth. It's a small-scale experiment involving 10 patients who will record their pain levels daily before and after two injections over three months.

What are the potential side effects?

Potential side effects may include localized reactions at injection sites such as swelling or bruising, muscle weakness near treated areas, difficulty swallowing if muscles are affected inadvertently, and less commonly systemic effects like breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My nerve pain does not improve with standard pain medication.

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I have ongoing dental pain with signs of nerve issues in my face, and other causes have been excluded.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder.

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I have a disorder affecting my nerves or muscles.

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I have difficulty swallowing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Intensity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BOTOXExperimental Treatment1 Intervention

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

onabotulinum toxin A

2016

Completed Phase 2

~20

0 / 5Eligibility criteria met