Trial for Treatment Refractory Trigeminal Neuralgia

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect other important medical events. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to drug was assessed by investigator.

S-STS is a scale that assesses the seriousness of suicidality phenomena on a 5-point Likert-type scale (0 to 4) ranging from "not at all" (0) to "extremely" (4), where higher scores signify suicidal tendency. In this outcome measure, number of participants who had any change in S-STS score from baseline to end of treatment are reported according to the treatment received in first or second treatment period of DBT phase.

ECG abnormalities included were a Corrected QT interval exceeding 470 milliseconds (QTc calculated using the Frederica method), left bundle branch block, right bundle branch block with a QRS duration of 150 milliseconds or more, and intraventricular conduction defect with a QRS duration equal to or greater than 150 milliseconds. Clinical significance in ECG abnormalities was judged by investigator.

Laboratory abnormalities included 1)Hematology: hemoglobin, hematocrit, platelets, complete blood count with differential and absolute neutrophil count; 2)Serum chemistry: sodium, potassium, chloride, calcium, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transferase, phosphorus, bicarbonate, creatine phosphokinase, total protein, albumin, total bilirubin, glucose, creatinine, blood urea nitrogen, uric acid, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, folate, hemoglobin A1C, pancreatic amylase or lipase, thyroid-stimulating Hormone, thyroxine; 3)Urinalysis: macroscopic examination, pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, protein, glucose, occult blood; 4)Liver function tests: alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase. Clinical significance in laboratory abnormalities was judged by investigator.

Penn-FPS-R: a 12-item scale, utilized to evaluate the impact of TN pain on health-related quality of life and daily activities. Each 12 items ranged from 0 (does not interfere) to 10 (completely interferes). Penn-FPS-R total score was calculated by adding scores of all items and had a score range of (does not interfere) 0 to 120 (completely interferes).Higher Penn-FPS-R total scores signifies worse condition. Participants were asked to complete the Penn-FPS-R at the beginning and end of each treatment period. Average of total Penn-FPS-score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure.

Pain disability index measures the extent of disruption in a participant's daily life caused by pain, utilizing a 7-item scale scored on an 11-point Likert Scale, where "0" denotes "no disability," and "10" indicates "worst disability". Higher scores signify worse outcome. Pain disability index total score was calculated by adding scores of all the 7 items and had a score range of 0 to 70. Higher pain disability index total scores signifies worse condition. Participants were instructed to complete the pain disability index at the beginning and end of each treatment period. Average of pain disability index total scores according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure.

PGI-C is a participant-reported scale utilized to evaluate the improvement or deterioration of the participant's current illness status compared to the baseline visit. Participants were asked to rate a change in their overall disease condition on a 7-point scale, ranging from 1 (no change) to 7 (a great deal better). Higher PGI-C scores signify better outcome. PGI-C assessments were conducted at the beginning and end of each treatment phase. Average of PGI-C score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure.

NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their worst pain rating over a 24-hour period on NPRS. Average of worst pain NPRS score according to treatment received in first or second treatment period of DBT phase are used in evaluation of the outcome measure.

NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT Phase are used in evaluation of the outcome measure.