The formation of carbamazepine metabolites and carbamazepine-protein conjugates in epilepsy patients

A pharmacokinetic investigation into the formation of carbamazepine metabolites and carbamazepine-protein conjugates in epilepsy patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62125126

Enrollment

158

Registered

2015-02-19

Start date

2013-11-05

Completion date

Unknown

Last updated

2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Neurological

Interventions

Patients in the auto-induction group will be newly prescribed carbamazepine. All other subjects in the study will have been prescribed carbamazepine by their neurologist as part of clinical care for p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Autoinduction group: 1. Subject is willing and able to give written informed consent 2. Subject is aged 18 or over 3.Subject is newly prescribed carbamazepine by their attending physician Maintenance group: 1. Subject is willing and able to give written informed consent 2. Subject is aged 18 or over 3. Subject has received CBZ therapy at the same dosage for at least 4 weeks

Exclusion criteria

Exclusion criteria: Autoinduction group: 1. Subject is not willing to take part or unable to give written informed consent 2. Subject has in the past 4 weeks received other medication that is a CYP3A4 inducer or inhibitor (see medications below) 3. Subject has taken part on another research study within 90 days of commencement 4. Subject has any condition which in the opinion of the investigator will interfere with the study Excluded medications: Rifampicin, Amiodarone, Fluvoxamine, Saquinavir, Rifampin, Amprenavir, Indinavir, SVerapamil, Isoniazid, Atazanavir, Lopinavir, Verapamil, Phenytoin, Azithromycin, Mifepristone, Phenobarbital, Grapefruit juice, Nelfinavir, Omeprazole, Clarithromycin, Norverapamil, Clotrimazole, Cyclosporine A, Ritonavir, HMGCoA reductase inhibitors, Delavirdine, Ndesmethylerythromycin, Cyclophosphamide, Erythromycin, Roxithromycin, Spironolactone, Fluoxetine, RVerapamil Maintenance group: 1. Subject is not willing to take part or unable to give written informed consent 2. Subject has any condition which in the opinion of the investigator will interfere with the study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic analyses; Timepoint(s): Time points dependent on time of presentation to clinic	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026