Trigeminal NeuralgiaPhase 4NCT04570293
5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
A Phase 4 study testing 5% lidocaine medicated plaster in people with Trigeminal Neuralgia, run by Beijing Tiantan Hospital at 5 sites in China.
Trial 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 minutes.Simple daily-life activities, such as washing the face, brushing the teeth, eating… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- 5% lidocaine medicated plaster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2021to 26 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Occurrence of episodes of intense facial paroxysmal pain in the distribution(s) of one or more divisions of the trigeminal nerve, triggered by innocuous stimuli;
- Average daily pain intensity ≥ 4 by a brief pain inventory-short form (BPI-SF) Item 5 score (0-10 rating scale of average pain) in the preceding 24-hour period;
- Concomitant analgesic regimens that include 14 days of stable doses with systemic analgesics rather than topical agents for relief of PHN will be permitted
- Normal neurologic examination;
- Normal neuroimaging analysis.
Who cannot join
- Atypical pain location (eg, no specific trigger points) or trigger zones in the mouth;
- Proposed surgical intervention due to preference of the patient;
- Any condition known to interfere with the correct execution of the sensory tests (eg, peripheral or central neurological dysfunction or cognitive impairments);
- Presence of any other acute or chronic pain disorder with the need of systemic analgesic medication for more than 10 days in the last 3 months;
- Inability to discontinue the use of another lidocaine-containing products or a class I anti-arrhythmic drug during the study period;
- History of hypersensitivity to an amide-type local anesthetic agent, or other contents of the lidocaine or vehicle patch;
Show all 11Show fewer
- History of surgical intervention or neurological ablation to treatment TN;
- Participation in another clinical trial within 30 days of the study;
- Any patient who was judged to be unreliable or unable to understand the protocol procedures;
- Any abnormality of the skin or of vascular origin at application site;
- Pregnancy or breastfeeding;.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Beijing China-Janpan Friendship Hospital
Beijing
Sanbo Brain Hospital, Capital Medical University
Beijing
Jilin province people's hospital
Jilin City
Linfen People's Hospital
Shanxi
About this study
Official title: The PATCH Trial: Effectiveness and Safety of 5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
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 minutes.Simple 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 patient's 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 used.5% 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- 5% lidocaine medicated plaster, vehicle plaster
- Keywords
- 5% Lidocaine-medicated Plaster, Trigeminal Neuralgia, Enriched Enrollment Randomized Withdrawal, Triggers
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% lidocaine medicated plasterDrug
The 5% lidocaine medicated plaster is measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w) For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.
vehicle plasterDrug
Vehicle patches are identical to the active patch, except for the absence of lidocaine, without any optical differences.For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.
| Study group | Role | What they receive |
|---|---|---|
| The LMP group | Experimental | The LMP group will receive lidocaine patches (active patches) measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w). Receives: Drug: 5% lidocaine medicated plaster |
| The control group | Placebo comparator | The control group will receive vehicle patches that are identical to the active patch, except for the absence of lidocaine, without any optical differences. Receives: Drug: vehicle plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase
Patients will be defined as treatment failure at the end of the double-blind treatment phase or premature discontinuation if one of the following situations occurs:
- A 50% or more increase in mean daily pain intensity experienced in the paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase.
- A 50% or more increase in the total number of paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase.
- The patient discontinues intervention due to lack of efficacy or intolerable side effects associated study patches.
Measured: Through study completion, an average of 7 weeks.
Secondary outcomes (12)
Time to loss of therapeutic response (LTR)
LTR will be defined as number of days to treatment failure in the double-blind phase after randomization.
Measured: During the double-blind phase after randomization, an average of 7weeks.
Proportion of responders and non-responders
A responder at the end of the open-label treatment phase will be defined as follows:
- A 30% or more decrease in mean daily pain intensity for the 7 days prior to Day 21 compared to that in the baseline phase while the LMP is applied and pain will return or increase when LMP is removed.
- A 30% or more decrease in the total number of paroxysms for the 7 days prior to Day 21 compared to that in the baseline phase.
- Regular plaster use will be defined as the plaster are applied every two days.
- In addition, no intolerable side effects occur at the dose of the existing patch.
Measured: Through the open-label period, an average of 3 weeks.
the proportion of the patients who report pain relief of 50% or greater
The pain relief will be assessed by Item 8 on the BPI-SF. Patients will be asked to circle the percentage value from 0% (no relief) to 100% (complete relief) that shows how much pain relief they have achieved during the prior 24 hours at end of open-label phase, and end of double-blind phase or premature discontinuation
Measured: At 3 weeks, 7 weeks
The pain intensity
Patients will be asked to circle the number on an 11-point Likert scale of 0 (no pain) to 10 (worst pain imaginable) that describe their worst pain (worst pain), their least pain (least pain) and their pain on average (average pain) in the previous 24 hours and how much pain they are experiencing at the time of the evaluation (pain right now).
Measured: Through study completion, an average of 7 weeks.
The number of paroxysms
The number of paroxysms experienced in the past 4 days weekly
Measured: Through study completion, an average of 7 weeks.
The severity of paroxysms
The severity of paroxysms experienced in the past 4 days weekly
Measured: Through study completion, an average of 7 weeks.
Quality of life (QoL)
Pain interference with the QOL will be assessed by Items 9A-G on the BPI-SF weekly. On these items, patients will be also asked to circle the number on an 11-point Likert scale of 0 (does not interfere) to 10 (completely interferes) that describes the extent to which pain have interfered with their activities of daily living during the prior 24 hours.
Measured: Through study completion, an average of 7 weeks.
Pittsburgh Sleep Quality Index (PSQI) at baseline, at end of open-label phase, and end of double-blind phase or premature discontinuation
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The total scores are 21. The higher the scores mean the worse the sleep.
Measured: At baseline, 3 weeks, 7weeks
Short form 36 health survey questionnaire (SF-36) at baseline, end of open-label phase, and end of double-blind phase or premature discontinuation
It measures health on eight multi-item dimensions, covering functional status, wellbeing, and overall evaluation of health.
Measured: At baseline, 3 weeks, 7weeks
The cost of treatment
The total cost of all medications for TN and the cost of LMP
Measured: Through study completion, an average of 7 weeks.
Patient Global Impression of Change (PGIC) at end of open-label phase, and end of double-blind phase or premature discontinuation
A 7-point Likert scale, where 1 = very much improved to 7 = very much worse with a value of 4 representing no change
Measured: At 3 weeks, 7 weeks
Study blindness
Both the clinician and patient can guess whether the drug used during double-blind phase is LMP or vehicle patches.
Measured: Through study completion, an average of 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 May 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570293
- Sponsor's protocol ID
- KY 2020-102-02
- Status last verified
- Mar 2023
- First submitted
- 22 Sep 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Di Stefano G, Maarbjerg S, Nurmikko T, Truini A, Cruccu G. Triggering trigeminal neuralgia. Cephalalgia. 2018 May;38(6):1049-1056. doi: 10.1177/0333102417721677. Epub 2017 Jul 14.
PubMed 28708009Liu M, Zhong J. Mechanism underlying cranial nerve rhizopathy. Med Hypotheses. 2020 Sep;142:109801. doi: 10.1016/j.mehy.2020.109801. Epub 2020 May 6.
PubMed 32413700Cheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer. 2009 Apr;17(4):451-60. doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13.
PubMed 19142669Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.
PubMed 12616661Tamburin S, Schweiger V, Magrinelli F, Brugnoli MP, Zanette G, Polati E. Effect of 5% lidocaine medicated plaster on pain intensity and paroxysms in classical trigeminal neuralgia. Ann Pharmacother. 2014 Nov;48(11):1521-4. doi: 10.1177/1060028014544166. Epub 2014 Jul 28.
PubMed 25070398Zhao C, Shrestha N, Ren H, Zhang B, Shen Y, Meng L, Wu D, Wang B, Fan B, Luo F. The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study. Headache. 2024 Nov-Dec;64(10):1318-1328. doi: 10.1111/head.14814. Epub 2024 Aug 28.
PubMed 39193836Zhao C, Shrestha N, Liu H, Shen Y, Meng L, Fan B, Luo F. The PATCH trial: efficacy and safety of 5% lidocaine-medicated plaster for the treatment of patients with trigeminal neuralgia: a study protocol for a multicentric, double-blind, enriched enrolment randomised withdrawal, vehicle-controlled study. BMJ Open. 2021 Aug 2;11(8):e045493. doi: 10.1136/bmjopen-2020-045493.
PubMed 34341037
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PATCH Trial: Effectiveness and Safety of 5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04570293
- Acronym / sponsor ID
- KY 2020-102-02
- Conditions
- Trigeminal Neuralgia
- Keywords
- 5% Lidocaine-medicated Plaster, Trigeminal Neuralgia, Enriched Enrollment Randomized Withdrawal, Triggers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 minutes.Simple 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 patient's 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 used.5% 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The LMP group | Experimental | Drug: 5% lidocaine medicated plasterThe LMP group will receive lidocaine patches (active patches) measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w). |
| The control group | Placebo comparator | Drug: vehicle plasterThe control group will receive vehicle patches that are identical to the active patch, except for the absence of lidocaine, without any optical differences. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Occurrence of episodes of intense facial paroxysmal pain in the distribution(s) of one or more divisions of the trigeminal nerve, triggered by innocuous stimuli;
- Average daily pain intensity ≥ 4 by a brief pain inventory-short form (BPI-SF) Item 5 score (0-10 rating scale of average pain) in the preceding 24-hour period;
- Concomitant analgesic regimens that include 14 days of stable doses with systemic analgesics rather than topical agents for relief of PHN will be permitted
- Normal neurologic examination;
- Normal neuroimaging analysis.
Key exclusion criteria (11 listed)
- Atypical pain location (eg, no specific trigger points) or trigger zones in the mouth;
- Proposed surgical intervention due to preference of the patient;
- Any condition known to interfere with the correct execution of the sensory tests (eg, peripheral or central neurological dysfunction or cognitive impairments);
- Presence of any other acute or chronic pain disorder with the need of systemic analgesic medication for more than 10 days in the last 3 months;
- Inability to discontinue the use of another lidocaine-containing products or a class I anti-arrhythmic drug during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% lidocaine medicated plasterThe 5% lidocaine medicated plaster is measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w) For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time. | Drug | The LMP group |
| vehicle plasterVehicle patches are identical to the active patch, except for the absence of lidocaine, without any optical differences.For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time. | Drug | The control group |
Primary outcome
the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase
Time frame: Through study completion, an average of 7 weeks.
Patients will be defined as treatment failure at the end of the double-blind treatment phase or premature discontinuation if one of the following situations occurs: * A 50% or more increase in mean daily pain intensity experienced in the paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase. * A 50% or more increase in the total number of paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase. * The patient discontinues intervention due to lack of efficacy or intolerable side effects associated study patches.
12 secondary outcomes
Time to loss of therapeutic response (LTR)
Time frame: During the double-blind phase after randomization, an average of 7weeks.
Proportion of responders and non-responders
Time frame: Through the open-label period, an average of 3 weeks.
the proportion of the patients who report pain relief of 50% or greater
Time frame: At 3 weeks, 7 weeks
The pain intensity
Time frame: Through study completion, an average of 7 weeks.
The number of paroxysms
Time frame: Through study completion, an average of 7 weeks.
The severity of paroxysms
Time frame: Through study completion, an average of 7 weeks.
Quality of life (QoL)
Time frame: Through study completion, an average of 7 weeks.
Pittsburgh Sleep Quality Index (PSQI) at baseline, at end of open-label phase, and end of double-blind phase or premature discontinuation
Time frame: At baseline, 3 weeks, 7weeks
Short form 36 health survey questionnaire (SF-36) at baseline, end of open-label phase, and end of double-blind phase or premature discontinuation
Time frame: At baseline, 3 weeks, 7weeks
The cost of treatment
Time frame: Through study completion, an average of 7 weeks.
Patient Global Impression of Change (PGIC) at end of open-label phase, and end of double-blind phase or premature discontinuation
Time frame: At 3 weeks, 7 weeks
Study blindness
Time frame: Through study completion, an average of 7 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 28708009Di Stefano G, Maarbjerg S, Nurmikko T, Truini A, Cruccu G. Triggering trigeminal neuralgia. Cephalalgia. 2018 May;38(6):1049-1056. doi: 10.1177/0333102417721677. Epub 2017 Jul 14.
- Background: PubMed 32413700Liu M, Zhong J. Mechanism underlying cranial nerve rhizopathy. Med Hypotheses. 2020 Sep;142:109801. doi: 10.1016/j.mehy.2020.109801. Epub 2020 May 6.
- Background: PubMed 19142669Cheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer. 2009 Apr;17(4):451-60. doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13.
- Background: PubMed 12616661Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.
- Background: PubMed 25070398Tamburin S, Schweiger V, Magrinelli F, Brugnoli MP, Zanette G, Polati E. Effect of 5% lidocaine medicated plaster on pain intensity and paroxysms in classical trigeminal neuralgia. Ann Pharmacother. 2014 Nov;48(11):1521-4. doi: 10.1177/1060028014544166. Epub 2014 Jul 28.
- Derived from this study: PubMed 39193836Zhao C, Shrestha N, Ren H, Zhang B, Shen Y, Meng L, Wu D, Wang B, Fan B, Luo F. The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study. Headache. 2024 Nov-Dec;64(10):1318-1328. doi: 10.1111/head.14814. Epub 2024 Aug 28.
- Derived from this study: PubMed 34341037Zhao C, Shrestha N, Liu H, Shen Y, Meng L, Fan B, Luo F. The PATCH trial: efficacy and safety of 5% lidocaine-medicated plaster for the treatment of patients with trigeminal neuralgia: a study protocol for a multicentric, double-blind, enriched enrolment randomised withdrawal, vehicle-controlled study. BMJ Open. 2021 Aug 2;11(8):e045493. doi: 10.1136/bmjopen-2020-045493.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Luo principal investigator
Beijing Tiantan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5% lidocaine medicated plaster in people with Trigeminal Neuralgia, run by Beijing Tiantan Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase (time frame: Through study completion, an average of 7 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570293, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.