Trigeminal NeuralgiaNCT07252453
Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia
A study testing Carbamazepine and oxcarbazepine in people with Trigeminal Neuralgia, run by Abbasi Shaheed Hospital at 1 site in Pakistan.
Trial summary
In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Carbamazepine and oxcarbazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Either gender
- TGN diagnosis for ≥2 weeks (according to ICHD-3 criteria¹)
Who cannot join
- Other cranial neuralgias
- Prior surgical treatment for TN
- Hepatic/renal dysfunction
- Epilepsy
- Pregnant/lactating women
- Drug allergy or intolerance
- [Expanded] Uncontrolled hypertension
- [Expanded] Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Abbassi Shaheed hospital Facio-Maxillary Department
Karachi, Sindh, 75500
About this study
Official title: Comparison of Carbamazepine and Oxcarbazepine In the Treatment of Trigeminal Neuralgia
In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine
Read the detailed description
In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects
- Conditions
- Trigeminal Neuralgia
- Being tested
- Carbamazepine, oxcarbazepine
- Keywords
- TGN, carbamazepine, oxcarbazepine
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Carbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain.
oxcarbazepineDrug
Oxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity
| Study group | Role | What they receive |
|---|---|---|
| Carbamazepine group | Active comparator | In this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management Receives: Drug: Carbamazepine |
| Oxcarbazepine group | Active comparator | In this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management Receives: Drug: oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief for TGN
Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document.
Measured: Two months
Secondary outcomes (1)
Side effects
Side effects of each drug will be compared including hepatotoxicity through liver functional tests, and other effects including nausea tolerability, dizziness etc. Annexure will be provided to each group participants ( same as mentioned in primary outcome section) ,which includes side effects column specifically Liver Functional Test results including both baselines values ( during the start of treatment ) and final results( at the end of treatment) and comparison will be made between the two drugs regarding side effects specifically hepatotoxicity.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 May 2025
- Primary completion20 Nov 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbasi Shaheed Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sikandar Zaidi, Abbasi Shaheed Hospital
- Investigators
- Dr.SUFYAN AHMED, FCPS, Study chair, KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252453
- Sponsor's protocol ID
- IRB/KMDC/KMU/128/2025
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcomes
Publications
1. International Headache Society. The International Classification of Headache Disorders (ICHD-3) - online edition, updated 2023. Available at: https://ichd-3.org
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carbamazepine and Oxcarbazepine In the Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT07252453
- Acronym / sponsor ID
- IRB/KMDC/KMU/128/2025
- Conditions
- Trigeminal Neuralgia
- Keywords
- TGN, carbamazepine, oxcarbazepine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Abbasi Shaheed HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Nov 2025 (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.
In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine
Detailed description
In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbamazepine group | Active comparator | Drug: CarbamazepineIn this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management |
| Oxcarbazepine group | Active comparator | Drug: oxcarbazepineIn this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (8 listed)
- Other cranial neuralgias
- Prior surgical treatment for TN
- Hepatic/renal dysfunction
- Epilepsy
- Pregnant/lactating women
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 |
|---|---|---|
| CarbamazepineCarbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain. | Drug | Carbamazepine group |
| oxcarbazepineOxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity | Drug | Oxcarbazepine group |
Primary outcome
Pain relief for TGN
Time frame: Two months
Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document.
1 secondary outcome
Side effects
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background1. International Headache Society. The International Classification of Headache Disorders (ICHD-3) - online edition, updated 2023. Available at: https://ichd-3.org
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Primary and secondary outcomes
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Trigeminal Neuralgia (TN)
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.
Dr.SUFYAN AHMED, FCPS study chair
KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbamazepine and oxcarbazepine in people with Trigeminal Neuralgia, run by Abbasi Shaheed Hospital at 1 site in Pakistan.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain relief for TGN (time frame: Two months). 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 NCT07252453, which also lists 1 linked publication.
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 26 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.