Danish Headache Center, Rigshospitalet - Glostrup
Glostrup Municipality, 2600, Denmark
NCT Number: NCT03712254
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Glostrup Municipality, 2600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with trigeminal neuralgia that due to acute exacerbations of trigeminal neuralgia pain are admitted for fosphenytoin loading are the subjects of interest.
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.
Danish Headache Center
Other
Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 30 Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06571448
Cranial Nerve Diseases, Facial Nerve Diseases
Beijing, China
View Trial DetailsNCT07046247
Cranial Nerve Diseases, Facial Nerve Diseases
Valencia, Spain
View Trial DetailsNCT04158752
Cranial Nerve Diseases, Facial Nerve Diseases
Durham, North Carolina, United States
View Trial DetailsNCT07304453
Cranial Nerve Diseases, Facial Nerve Diseases
Karbala, Kerbala, Iraq
View Trial Details