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

Not Applicable

Completed

• Conditions: Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Epilepsy; Nervous System Diseases

• Registration Number: ISRCTN62125126
• Lead Sponsor: niversity of Liverpool

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33217013/ (added 21/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-19
• Study Completion: 2015-04-30
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 158

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic analyses; Timepoint(s): Time points dependent on time of presentation to clinic