amitriptyline and Dysesthesia

amitriptyline has been researched along with Dysesthesia in 16 studies

Amitriptyline: Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
amitriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5.

Research

Studies (16)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Change in Absolute Headache Disability Score on PedMIDAS

"The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:~Amitriptyline vs. Placebo~Topiramate vs. Placebo~Amitriptyline vs Topiramate" (NCT01581281)
Timeframe: baseline and 24 week endpoint

Change in Number of Headache Days

"This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:~Amitriptyline vs. placebo~Topiramate vs. placebo~Amitriptyline vs. Topiramate" (NCT01581281)
Timeframe: 4 week baseline period and last 4 weeks of the 24-week trial

Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days

"The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.~For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups." (NCT01581281)
Timeframe: 4 week baseline period and last 4 weeks of the 24-week trial

Occurrence of Treatment Emergent Serious Adverse Events

To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events. (NCT01581281)
Timeframe: 24 weeks of the trial

Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase

To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups. (NCT01581281)
Timeframe: 24 weeks

Reviews

1 review available for amitriptyline and Dysesthesia

Trials

4 trials available for amitriptyline and Dysesthesia

Other Studies

11 other studies available for amitriptyline and Dysesthesia