Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04570293
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2020-09-22
Brief Title:
5 Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
The PATCH Trial Effectiveness and Safety of 5 Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trigeminal neuralgia TN is characterized by sudden severe usually unilateral transient stinging recurrent electrocute-like shock in one or more divisions of the trigeminal nerve lasting from a few seconds to less than 2 minutesSimple daily-life activities such as washing the face brushing the teeth eating and talking or the slight touch of trigger points may trigger the attack of pain of TN resulting in a decline in the patients quality of life QoL Trigger zones predominantly locate in the perioral and nasal region Paroxysmal pain is associated with triggers in virtually all patients with TN TN may be caused by abnormality of the trigger zone and the blockade of Na channel of trigger zone may be a novel and effective treatment methods for TN Currently most patients with TN may not achieve adequate pain relief with a single therapeutic agent Multiple analgesics targeting different mechanisms of the pain pathway are often used5 lidocaine medicated plaster LMP is a white hydrogel plaster containing adhesive material LMP was approved for post-herpetic neuralgia PHN treatment by the United States Food and Drug Administration FDA in 1999 Tamburin et al reported that 2 patients with primary TN who stopped oral drugs because of side effects or refused surgical procedures Both patients were instructed to wear LMP over the affected area and LMP resulted in reduction of pain intensity and the number of pain paroxysms without side effects However due to limitations of these open-label design studies the observed reductions in pain intensity may have been due to treatment effect placebo effect changes in underlying disease state or a combination of these factors Therefore randomized controlled trials will be need to be performed to draw about the efficacy of the LMP in TN
The PATCH trial is a prospective double-blinded vehicle-controlled parallel-group multicenter enriched enrolment with randomized withdrawal EERW trial aimed at estimating the efficacy and safety of LMP in patients with TN After providing informed consent and completing a baseline evaluation patients will participate in an initial open-label treatment period of LMP active patches This openly titrated process is close to clinical practice and can provide data on the proportion of responders and non-responders the optimal dose of the analgesic drug and the proportion of withdrawal due to adverse effects A responder at the end of the open-label treatment phase will be included in the subsequently double-blind treatment phase
The PATCH trial is a prospective double-blinded vehicle-controlled parallel-group multicenter enriched enrolment with randomized withdrawal EERW trial aimed at estimating the efficacy and safety of LMP in patients with TN After providing informed consent and completing a baseline evaluation patients will participate in an initial open-label treatment period of LMP active patches This openly titrated process is close to clinical practice and can provide data on the proportion of responders and non-responders the optimal dose of the analgesic drug and the proportion of withdrawal due to adverse effects A responder at the end of the open-label treatment phase will be included in the subsequently double-blind treatment phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None