Trigeminal NeuralgiaPhase 4NCT04996199
Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial
A Phase 4 study testing Oxcarbazepine and Carbamazepine in people with Trigeminal Neuralgia, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
Trigeminal neuralgia is a neuropathic facial pain condition, characterized by unilateral paroxysmal pain which can be described as stabbing or electric shock like, in the distribution of one or more divisions of trigeminal nerve which is triggered by innocuous stimuli. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Oxcarbazepine and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesIndia
- Study dates
- 18 Sep 2021to 31 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinically proven cases of primary trigeminal neuralgia.
- Patients who are willing to participate in the study.
Who cannot join
- Intolerance to either of the two drugs
- Medically compromised patients
- Patients with pacemaker
- Patients who have previously undergone surgical treatment for TRIGEMINAL NEURALGIA.
- Patients who are already on pharmacotherapy for TRIGEMINAL NEURALGIA.
- Seizure disorder/ pregnant/ lactating
Show all 9Show fewer
- Renal/ hepatic impairment
- History of hyponatermia
- Concurrent medication- dilantin, phenytoin
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Dr. Sanjay Tewari, MDS, 01262283876, principalpgids@yahoo.in
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
SANJAY TEWARI, MDS, 01262283876, principalpgids@yahoo.in
AMBIKA GUPTA
About this study
Official title: Comparative Efficacy of Carbamazepine Versus Oxcarbazepine in Treatment of Trigeminal Neuralgia- a Randomized Controlled Clinical Study
Trigeminal neuralgia is a neuropathic facial pain condition, characterized by unilateral paroxysmal pain which can be described as stabbing or electric shock like, in the distribution of one or more divisions of trigeminal nerve which is triggered by innocuous stimuli. The attack is provoked by touching or stimulating these trigger zones. There are various pharmacological drugs present for the treatment of trigeminal neuralgia. Carbamazepine and oxcarbazepine are the first-choice drugs for the treatment of TN. Other drugs include lamotrigine , baclofen , gabapentin, antidepressants , eslicarbazepine , sumatriptan \& vixitrigine. The carbamazepine is first choice of drug which has serious side effects including dizziness, memory loss, sleppiness, aplastic anaemia. Oxcarbazepine has similar mechanism of action and found to have lesser adverse events when used in various neuralgias in the place of carbamazepine. But there is still lack of evidence to prove that oxcarbazepine can be used as monotherapy in TN patients.
Read the detailed description
Trigeminal neuralgia is a neuropathic facial pain condition which is characterised by unilateral paroxysmal pain which is excruciating, short lasting in the distribution territory of trigeminal nerve.(1) Trigeminal neuralgia is oro-facial pain restricted to one or more divisions of the trigeminal nerve. With the exception of Trigeminal Neuralgia caused by Multiple sclerosis, the pain affects one side of the face. It is abrupt in onset and typically lasts only a few seconds (2 min at maximum).Patients may report their pain as arising spontaneously, but these pain paroxysms can always be triggered by innocuous mechanical stimuli or movements. Patients usually do not experience pain between paroxysms. If they do report additional continuous pain, in the same distribution and in the same periods as the paroxysmal pain, they are considered to have Trigeminal Neuralgia with continuous pain. (IASP)(1) Trigeminal neuralgia is mainly classified into three diagnostic categories i.e. Classical, Secondary and Idiopathic. This classification is mainly based on the etiology \& pain characteristics. The etiology of Trigeminal Neuralgia is not well understood, but various theories such as Compression of sensory root of trigeminal nerve by arteries \& bony exostoses.(4) ,focal demyelination of trigeminal afferents near the entry of the trigeminal root into pons(2)and alteration in the central neural function followed by injury to peripheral nerves (4) are widely accepted.
Trigeminal Neuralgia has a profound effect on quality of life of the patient \& expenditure on health (4). Due to the severe intensity of pain, patients avoid touching face, washing face, thus making patient's life disturbing \& miserable. Even after so many years of research, it is still a challenge to treat patients suffering from Trigeminal Neuralgia. Treatment can be sub- divided into pharmacological \& invasive therapies .
The pharmacological therapy include drugs such as carbamazepine ( 200-1200mg) , oxcarbazepine (300-1800mg) , lamotrigine, Gabapentin , baclofen, eslicarbazepine, sumatriptan, vixotrigine. The pre- surgical procedures like botulinium toxin A \& intranasal non-inhaled CO2 have also been sporadically used (1).
A review study discussing the pharmacological options to treat trigeminal neuralgia concluded that carbamazepine \& oxcarbazepine are the first choice of drugs(1). Oxcarbazepine showed equal efficacy in reducing pain attacks with better tolerability \& less side effects (1) .
A recently conducted study found that carbamazepine is associated with serious side effects including CNS disturbances, somnolence, unbalance, thrombocytopenia, increase level of transaminases while OXC showed similar efficacy with less side effects. CNS disturbances encountered in patients on CBZ were triple to those on OXC \& withdrawal from the treatment was also more in patients on CBZ(27%) than on OXC (18%)(12).
OXC has contemporarily been used as monotherapy in epileptic patients (8) \& has proven efficacy over the CBZ. In trigeminal neuralgia, though various studies have shown that OXC produce lesser side effects, but none of the studies have compared the efficacy of carbamazepine with oxcarbazepine .
Thus the present study intends to compare the efficacy of oxcarbazepine with carbamazepine as monotherapy in patients suffering from trigeminal neuralgia.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Oxcarbazepine, Carbamazepine
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxcarbazepineDrug
Also called LOVAX
oxcarbazepine 150mg BD initial dose , followup will be done at 15days, 6weeks, 10 weeks interval
CarbamazepineDrug
Also called zileuton
carbamazepine 100mg BD initial dose, follow up will be done 2weeks, 6 weeks \& 10weeks
| Study group | Role | What they receive |
|---|---|---|
| Oxcarbazepine GROUP | Experimental | Oxcarabazepine 150mg BD starting dose \& will be increased if the patient is not relieved Receives: Drug: Oxcarbazepine |
| Carbamzepine GROUP | Active comparator | carbamazepine 100mg BD initial dose \& will be increased if the patient is not relieved Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Visual analog scale ( scale 0 to 10, where higher score means worst outcome)
Measured: 10 weeks
Secondary outcomes (5)
Adverse effects of drugs in both the groups.
side effects will be asked at each visit
Measured: 10 weeks
Need for adding 2nd line therapy in both the groups.
if pateint is not satisfied with treatment, then 2nd line drug will be used
Measured: 10 weeks
Number of patients withdrawal from study due to non compliance to drug
Drug tolerability in both the groups
Measured: 10 weeks
Treatment satisfaction in both the groups.
likert scale is used in both groups 1-5 scale, higher score means better outcome
Measured: 10 weeks
Quality of life in both the groups.
Oral health impact profile 14 score will be used, higher score means worst outcome
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start18 Sep 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996199
- Sponsor's protocol ID
- suman008
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Carbamazepine Versus Oxcarbazepine in Treatment of Trigeminal Neuralgia- a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04996199
- Acronym / sponsor ID
- suman008
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 9 Aug 2021 (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 is a neuropathic facial pain condition, characterized by unilateral paroxysmal pain which can be described as stabbing or electric shock like, in the distribution of one or more divisions of trigeminal nerve which is triggered by innocuous stimuli. The attack is provoked by touching or stimulating these trigger zones. There are various pharmacological drugs present for the treatment of trigeminal neuralgia. Carbamazepine and oxcarbazepine are the first-choice drugs for the treatment of TN. Other drugs include lamotrigine , baclofen , gabapentin, antidepressants , eslicarbazepine , sumatriptan \& vixitrigine. The carbamazepine is first choice of drug which has serious side effects including dizziness, memory loss, sleppiness, aplastic anaemia. Oxcarbazepine has similar mechanism of action and found to have lesser adverse events when used in various neuralgias in the place of carbamazepine. But there is still lack of evidence to prove that oxcarbazepine can be used as monotherapy in TN patients.
Detailed description
Trigeminal neuralgia is a neuropathic facial pain condition which is characterised by unilateral paroxysmal pain which is excruciating, short lasting in the distribution territory of trigeminal nerve.(1) Trigeminal neuralgia is oro-facial pain restricted to one or more divisions of the trigeminal nerve. With the exception of Trigeminal Neuralgia caused by Multiple sclerosis, the pain affects one side of the face. It is abrupt in onset and typically lasts only a few seconds (2 min at maximum).Patients may report their pain as arising spontaneously, but these pain paroxysms can always be triggered by innocuous mechanical stimuli or movements. Patients usually do not experience pain between paroxysms. If they do report additional continuous pain, in the same distribution and in the same periods as the paroxysmal pain, they are considered to have Trigeminal Neuralgia with continuous pain. (IASP)(1) Trigeminal neuralgia is mainly classified into three diagnostic categories i.e. Classical, Secondary and Idiopathic. This classification is mainly based on the etiology \& pain characteristics. The etiology of Trigeminal Neuralgia is not well understood, but various theories such as Compression of sensory root of trigeminal nerve by arteries \& bony exostoses.(4) ,focal demyelination of trigeminal afferents near the entry of the trigeminal root into pons(2)and alteration in the central neural function followed by injury to peripheral nerves (4) are widely accepted.
Trigeminal Neuralgia has a profound effect on quality of life of the patient \& expenditure on health (4). Due to the severe intensity of pain, patients avoid touching face, washing face, thus making patient's life disturbing \& miserable. Even after so many years of research, it is still a challenge to treat patients suffering from Trigeminal Neuralgia. Treatment can be sub- divided into pharmacological \& invasive therapies .
The pharmacological therapy include drugs such as carbamazepine ( 200-1200mg) , oxcarbazepine (300-1800mg) , lamotrigine, Gabapentin , baclofen, eslicarbazepine, sumatriptan, vixotrigine. The pre- surgical procedures like botulinium toxin A \& intranasal non-inhaled CO2 have also been sporadically used (1).
A review study discussing the pharmacological options to treat trigeminal neuralgia concluded that carbamazepine \& oxcarbazepine are the first choice of drugs(1). Oxcarbazepine showed equal efficacy in reducing pain attacks with better tolerability \& less side effects (1) .
A recently conducted study found that carbamazepine is associated with serious side effects including CNS disturbances, somnolence, unbalance, thrombocytopenia, increase level of transaminases while OXC showed similar efficacy with less side effects. CNS disturbances encountered in patients on CBZ were triple to those on OXC \& withdrawal from the treatment was also more in patients on CBZ(27%) than on OXC (18%)(12).
OXC has contemporarily been used as monotherapy in epileptic patients (8) \& has proven efficacy over the CBZ. In trigeminal neuralgia, though various studies have shown that OXC produce lesser side effects, but none of the studies have compared the efficacy of carbamazepine with oxcarbazepine .
Thus the present study intends to compare the efficacy of oxcarbazepine with carbamazepine as monotherapy in patients suffering from trigeminal neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxcarbazepine GROUP | Experimental | Drug: OxcarbazepineOxcarabazepine 150mg BD starting dose \& will be increased if the patient is not relieved |
| Carbamzepine GROUP | Active comparator | Drug: Carbamazepinecarbamazepine 100mg BD initial dose \& will be increased if the patient is not relieved |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically proven cases of primary trigeminal neuralgia.
- Patients who are willing to participate in the study.
Key exclusion criteria (9 listed)
- Intolerance to either of the two drugs
- Medically compromised patients
- Patients with pacemaker
- Patients who have previously undergone surgical treatment for TRIGEMINAL NEURALGIA.
- Patients who are already on pharmacotherapy for TRIGEMINAL NEURALGIA.
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 |
|---|---|---|
| OxcarbazepineAlso: LOVAXoxcarbazepine 150mg BD initial dose , followup will be done at 15days, 6weeks, 10 weeks interval | Drug | Oxcarbazepine GROUP |
| CarbamazepineAlso: zileutoncarbamazepine 100mg BD initial dose, follow up will be done 2weeks, 6 weeks \& 10weeks | Drug | Carbamzepine GROUP |
Primary outcome
Change in pain scores
Time frame: 10 weeks
Visual analog scale ( scale 0 to 10, where higher score means worst outcome)
5 secondary outcomes
Adverse effects of drugs in both the groups.
Time frame: 10 weeks
Need for adding 2nd line therapy in both the groups.
Time frame: 10 weeks
Number of patients withdrawal from study due to non compliance to drug
Time frame: 10 weeks
Treatment satisfaction in both the groups.
Time frame: 10 weeks
Quality of life in both the groups.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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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.
2 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 Oxcarbazepine and Carbamazepine in people with Trigeminal Neuralgia, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Tewari, MDS (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.