Trigeminal NeuralgiaNCT06357260
Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients
A study testing Pregabalin and Carbamazepine and Carbamazepine in people with Trigeminal Neuralgia, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Pregabalin and Carbamazepine and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2024to Mar 2025
- Phase
- Interventional
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II.
- Patient's consent for participation in this study.
Who cannot join
- Pregnant and lactating women
- Patients on anti-depressants like sodium valproate
- History of excessive alcohol intake
- Hepatic or renal insufficiency
- Known tolerance/allergy to study drug
- Non -compliant during screening period
- Any other hepatic microsomal enzyme inhibitors (to avoid risk for toxicity)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
DR. Lavina Arya, MDS, 09212795285, aryalavina@gmail.com
Dr. Ambika Gupta, MDS, 09315903300, drambika79@rediffmail.com
About this study
Official title: Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial
Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated.
Read the detailed description
AIM
Evaluation of Efficacy of Pregabalin as an add on therapy with Carbamazepine in patients with trigeminal neuralgia.
OBJECTIVES
Primary objectives-
- To compare the change in pain intensity in both groups.
Secondary objectives-
- To evaluate the mean dose of carbamazepine used in both the groups.
- To evaluate quality of life.
- To evaluate the patient satisfaction in both groups.
- To evaluate the need for additional pain medicine in both groups.
STUDY DESIGN
A randomized clinical trial will be conducted in department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.
STUDY SETTING
Hospital based study - Patients diagnosed with Trigeminal neuralgia will be recruited in study from regular OPD of the department of Oral Medicine and Radiology.
STUDY PERIOD
This study will be completed in 1 year.
STUDY SUBJECTS
Patients diagnosed with classical Trigeminal neuralgia will be recruited in the study from regular OPD of the Department of Oral Medicine and Radiology, PGIDS, Rohtak, Haryana. A total of 50 patients would compromise; Test group (n=25) and Control group (n=25).
METHOD OF RECRUITMENT Patient will be randomly allocated to test and control groups by using simple random sampling.
INTERVENTION
Clinically and MRI proven cases of classical Trigeminal neuralgia will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups.
TEST GROUP
Test group will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.
CONTROL GROUP
In control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.
Both groups will be assessed for the following parameters: intensity of pain, at the baseline ,1st week, 2nd week, 4th week ,6th week and 8th weeks interval.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Pregabalin and Carbamazepine, 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.
Pregabalin and CarbamazepineDrug
Also called Test group
Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need
CarbamazepineDrug
Also called Control group
Carbamazepine with dose of Carbazmaepine being titrated as per patients's need
| Study group | Role | What they receive |
|---|---|---|
| Test group-1 | Experimental | Carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need Receives: Drug: Pregabalin and Carbamazepine |
| Control group | Active comparator | Carbamazepine with dose of Carbamazepine being titrated as per patients's need Receives: Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
0- no pain 10-worst pain possible .Higher score means worst outcome
Measured: 0-8 weeks
Brief pain inventory
1-4=mild pain. 07-10 =severe pain. Higher score means worst outcome
Measured: 0-8 weeks
Secondary outcomes (3)
Mean dose of carbamazepine
lower dose requirement of carbamazepine means better outcome
Measured: 0-8 weeks
Patient global impression of scale
1- very much improved and 7-very much worse .Higher score means worst outcome
Measured: 0-8 weeks
Liverpool scale
Scale meant for adverse events score ranging from 19 -76 with higher score indicating greater adverse event related to drug
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks. control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shifa Akhtar, BDS, Principal investigator, Post Graduate Institute of Dental Sciences ,Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357260
- Sponsor's protocol ID
- Shifa OMR
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Pregabalin as an Add on Therapy With Carbamazepine in Patients of Trigeminal Neuralgia"- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06357260
- Acronym / sponsor ID
- Shifa OMR
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Apr 2024 (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 very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated.
Detailed description
AIM
Evaluation of Efficacy of Pregabalin as an add on therapy with Carbamazepine in patients with trigeminal neuralgia.
OBJECTIVES
Primary objectives-
- To compare the change in pain intensity in both groups.
Secondary objectives-
- To evaluate the mean dose of carbamazepine used in both the groups.
- To evaluate quality of life.
- To evaluate the patient satisfaction in both groups.
- To evaluate the need for additional pain medicine in both groups.
STUDY DESIGN
A randomized clinical trial will be conducted in department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.
STUDY SETTING
Hospital based study - Patients diagnosed with Trigeminal neuralgia will be recruited in study from regular OPD of the department of Oral Medicine and Radiology.
STUDY PERIOD
This study will be completed in 1 year.
STUDY SUBJECTS
Patients diagnosed with classical Trigeminal neuralgia will be recruited in the study from regular OPD of the Department of Oral Medicine and Radiology, PGIDS, Rohtak, Haryana. A total of 50 patients would compromise; Test group (n=25) and Control group (n=25).
METHOD OF RECRUITMENT Patient will be randomly allocated to test and control groups by using simple random sampling.
INTERVENTION
Clinically and MRI proven cases of classical Trigeminal neuralgia will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups.
TEST GROUP
Test group will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.
CONTROL GROUP
In control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.
Both groups will be assessed for the following parameters: intensity of pain, at the baseline ,1st week, 2nd week, 4th week ,6th week and 8th weeks interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks. control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain.
| Arm | Type | Receives |
|---|---|---|
| Test group-1 | Experimental | Drug: Pregabalin and CarbamazepineCarbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need |
| Control group | Active comparator | Drug: CarbamazepineCarbamazepine with dose of Carbamazepine being titrated as per patients's need |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Trigeminal neuralgia with classical types without concomitant pain as per ICHD-II.
- Patient's consent for participation in this study.
Key exclusion criteria (7 listed)
- Pregnant and lactating women
- Patients on anti-depressants like sodium valproate
- History of excessive alcohol intake
- Hepatic or renal insufficiency
- Known tolerance/allergy to study drug
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 |
|---|---|---|
| Pregabalin and CarbamazepineAlso: Test groupCarbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need | Drug | Test group-1 |
| CarbamazepineAlso: Control groupCarbamazepine with dose of Carbazmaepine being titrated as per patients's need | Drug | Control group |
Primary outcome
Visual analogue scale
Time frame: 0-8 weeks
0- no pain 10-worst pain possible .Higher score means worst outcome
Brief pain inventory
Time frame: 0-8 weeks
1-4=mild pain. 07-10 =severe pain. Higher score means worst outcome
3 secondary outcomes
Mean dose of carbamazepine
Time frame: 0-8 weeks
Patient global impression of scale
Time frame: 0-8 weeks
Liverpool scale
Time frame: 0-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Shifa Akhtar, BDS principal investigator
Post Graduate Institute of Dental Sciences ,Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Carbamazepine and Carbamazepine in people with Trigeminal Neuralgia, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site 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 7 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 (09416259534, principalpgids@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 0-8 weeks). The study lists 2 primary outcomes in all. 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 10 Jun 2024.