Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 20 Patients

NCT03712254 | Completed

• 1 other identifier: H-18023737
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The nature of trigeminal neuralgia (TN) is fluctuating and patients can experience periods of complete remission of pain as well as periods with excessive pain. TN is often triggered by innocuous intra- and extraoral stimuli such as chewing. Since the first-line prophylactic drugs, i.e. carbamazepine and oxcarbazepine, are administered orally, medical treatment of TN can be problematic in periods of exacerbation. In cases of severe exacerbation, patients oftentimes become dehydrated and anorectic as eating and drinking will evoke pain. Treatment with drugs administered intravenously is needed in such situations. Phenytoin was the first drug to be used for TN but it is rarely used as long-time preventative because of frequent side-effects associated with long-term use. However, phenytoin has the advantage over other drugs, that it can be administered also intravenously as fosphenytoin (the prodrug of phenytoin). By clinical experience the efficacy is very good. However, evidence of the treatment is lacking as only case reports including a total of 5 patients described the effects and side effects with pain relief lasting two days. By providing solid observational evidence, the treatment can be considered for incorporation in local and international treatment guidelines. The aim of the study is to test the hypothesis that fosphenytoin loading reduces TN pain with at least 50 % in 80% of patients with trigeminal neuralgia experiencing exacerbation of TN pain. The study is a descriptive prospective observational pilot study with 3 months followup period.

Conditions

Trigeminal Neuralgia

Keywords

acute pain, fosphenytoin

Outcome Measures

Primary Outcomes (1)

• Degree of acute pain relief

  Degree of pain relief measured by the verbal numeric rating scale of pain 24 hours after treatment compared with 24 hours before treatment.

  Primary outcome is measured app. 24 hours after fosphenytoin loading.

Interventions

Fosphenytoin DRUG

Patients with trigeminal neuralgia that due to acute exacerbations of trigeminal neuralgia pain are admitted for fosphenytoin loading are the subjects of interest.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with trigeminal neuralgia admitted for fosphenytoin loading due to acute exacerbations of trigeminal neuralgia pain.

You may qualify if:

• Age 18 years or older.
• Must be able to give signed informed consent prior to study entry.
• Must fulfill the ICHD-3 diagnostic criteria for TN. Both patients with purely paroxysmal TN and patients with TN with concomitant persistent facial pain will be included.
• MRI of the brain, brainstem and trigeminal nerve or patient is willing to undergo MRI in the days and weeks following admission.
• Must be able to adhere to the study protocol and understand either Danish or English.

You may not qualify if:

• Psychiatric or mental illness or condition that might interfere with the ability of the patients to fill in the Informed Consent.
• Contraindications for phosphenytoin loading such as sick sinus syndrome, atrioventricular block and hepatic insufficiency.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center, Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Andersen ASS, Heinskou TB, Asghar MS, Rossen B, Noory N, Smilkov EA, Bendtsen L, Maarbjerg S. Intravenous fosphenytoin as treatment for acute exacerbation of trigeminal neuralgia: A prospective systematic study of 15 patients. Cephalalgia. 2022 Oct;42(11-12):1138-1147. doi: 10.1177/03331024221094536. Epub 2022 Apr 25.

  PMID: 35469443 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia; Acute Pain

Interventions

fosphenytoin

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

DK (1)