An observational study in Trigeminal Neuralgia, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by Danish Headache Center · Observational
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.
138 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's enrollment of 15 is below the median of 82 across 36 observational studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with trigeminal neuralgia admitted for fosphenytoin loading due to acute exacerbations of trigeminal neuralgia pain.
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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.
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.
Time frame: Primary outcome is measured app. 24 hours after fosphenytoin loading.
Ran from Nov 2018 to primary completion in Oct 2021, 35 months.
Of 18 observational studies under Trigeminal Neuralgia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 87. This study's 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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