Condition category
Nervous System Diseases
Date applied
18/02/2015
Date assigned
19/02/2015
Last edited
19/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Yip

ORCID ID

Contact details

University of Liverpool
Wolfson Centre for Personalised Medicine
Department of Pharmacology
Block A: Waterhouse Buildings
1–5 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Additional identifiers

EudraCT number

2013-002743-28

ClinicalTrials.gov number

Protocol/serial number

15543

Study information

Scientific title

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

Acronym

PICME II

Study hypothesis

This study aims to improve our mechanistic understanding of carbamazepine hypersensitivity by using high sensitivity mass spectrometry to characterise and quantify the stable and toxic products formed in the blood and urine of patients receiving carbamazepine therapy.

Ethics approval

13/NW/0503

Study design

Non-randomised; Both; Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Epilepsy

Intervention

Carbamazepine therapy: 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 patient for at least 4 weeks.

Intervention type

Drug

Phase

Drug names

Carbamazepine

Primary outcome measures

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

Secondary outcome measures

N/A

Overall trial start date

05/11/2013

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 158; UK Sample Size: 158

Participant 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

Recruitment start date

05/11/2013

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Wolfson Centre for Personalised Medicine Department of Pharmacology Block A: Waterhouse Buildings 1–5 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

Head of Division of Primary Care
Whelan Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes