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

March 23, 2022 updated by: Lars Bendtsen, Danish Headache Center

Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 30 Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center, Rigshospitalet - Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of acute pain relief
Time Frame: Primary outcome is measured app. 24 hours after fosphenytoin loading.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18023737

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Trigeminal Neuralgia

Clinical Trials on Fosphenytoin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe