UMIN-CTR Clinical Trial

Public title

Genotype-Based Carbamazepine Therapy (GENCAT) study

Acronym

Genotype-Based Carbamazepine Therapy (GENCAT) study

Scientific Title

Genotype-Based Carbamazepine Therapy (GENCAT) study

Scientific Title:Acronym

Genotype-Based Carbamazepine Therapy (GENCAT) study

Region

Japan

Condition

Epilepsy (partial seizure), schizophrenia, bipolar disorder, trigeminal neuralgia

Classification by specialty

Neurology	Pediatrics	Psychiatry
Emergency medicine

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Determination of whether prospective screening by means of HLA-A*3101 genotyping before deciding on carbamazepine treatment reduces the incidence of carbamazepine-induced skin rash

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Incidence of drug-induced skin rash.
1) Stevens-Johnson syndrome (SJS)
2) Toxic epidermal necrolysis (TEN)
3) Drug-induced hypersensitivity syndrome (DIHS)
4) Maculopapular eruption (MPE)
5) Erythema multiforme (EM)
6) Fixed drug eruption (FDE)

Key secondary outcomes

Incidence of other adverse events.
1) Fever
2) Sore throat
3) Fatigue
4) Dizziness
5) Insomnia
6) Gastrointestinal symptoms (asitia, obstipation, diarrhea, xerostomia, nausea, vomiting)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

HLA-A*3101-negative patients are treated with carbamazepine, whereas HLA-A*3101-positive patients are treated with alternative drugs (such as valproic acid, gabapentin, levetiracetam, topiramate, lithium carbonate, olanzapine).

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Japanese males and females with epilepsy (partial seizure), excitement of schizophrenia, manic phase of bipolar disorder, trigeminal neuralgia, who will take carbamazepine
2) Patients who have not been taking carbamazepine within a month before entry
3) Patients or legally authorized representative who can understand the contents of this study and will voluntarily give written informed consent

Key exclusion criteria

1) Patients with a history of skin rash induced by carbamazepine.
2) Pregnancy and lactation patients
3) Patients with severe renal failure (serum creatinine>=2.5 mg/dL, or patients on hemodialysis)
4) Patients with cirrhosis
5) Patients with hypoproteinemia (serum albumin<=2.5 g/dL)
6) Patient who are incapable to understand the contents of this study and will not give informed consent
7) Patients who participate in other clinical studies
8) Patients judged by investigators as ineligible for study enrollment

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Michiaki Kubo

Organization

RIKEN

Division name

Center for Integrative Medical Sciences

Zip code

Address

1-7-22, Suehiro-cho, Tsurumi-ku, Yokohama 230-0045, Japan

TEL

045-503-9607

Email

Name of contact person

1st name
Middle name
Last name

Organization

Institute of Medical Science, The University of Tokyo

Division name

Biobank Japan

Zip code

Address

4-6-1, Shirokanedai, Minato-ku 108-8639, Japan

TEL

03-5449-5122

Homepage URL

http://www.biobankjp.org/pgx/

Email

Institute

RIKEN

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science & Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Institute of Medical Science, The University of Tokyo

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

12

Month

01

Day

URL releasing protocol

http://www.biobankjp.org/pgx/

Publication of results

Published

URL related to results and publications

https://jamanetwork.com/journals/jamaneurology/article-abstract/2676800

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

2014

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

30

Day

Last modified on

2019

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008044