Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 20 Patients
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|ClinicalTrials.gov Identifier: NCT03712254|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 25, 2019
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.
|Condition or disease||Intervention/treatment|
|Trigeminal Neuralgia||Drug: Fosphenytoin|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 30 Patients|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||April 1, 2020|
- Drug: Fosphenytoin
Patients with trigeminal neuralgia that due to acute exacerbations of trigeminal neuralgia pain are admitted for fosphenytoin loading are the subjects of interest.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712254
|Contact: Lars Bendtsen, MD, PhD, Dr Med Sciemail@example.com|
|Contact: Anne Sofie Schott Andersen, MD, PhD Dr. Med Scifirstname.lastname@example.org|
|Danish Headache Center, Rigshospitalet - Glostrup||Recruiting|
|Glostrup, Denmark, 2600|
|Contact: Lars Bendtsen, MD, PhD, Dr Med Sci +4538633065 email@example.com|