Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00630

2 Trial Registration Date

2018-10-19

i Registration Status

Prospective

3 Secondary IDs

CRE Ref. No. 2018.384

4 Source(s) of Funding

Beat Drugs Fung Association: BDF170039

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Tse Sau Man Celia

ii Address

Room 7B44, 7/F, Clinical and Trauma Centre, Prince of Wales Hospital, Shatin

iii Phone

57431802

iv Email

saumanceliatse@cuhk.edu.hk

v Affiliation

Division of Neurology, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ho Wan Leung

ii Address

Division of Neurology,
Department of Medicine & Therapeutics,
Price of Wales Hospital, Shatin

iii Phone

35053856

iv Email

Howanleung@cuhk.edu.hk

v Affiliation

Division of Neurology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Multi-disciplinary Support for Patients with Epilepsy and Psychotropic Drug Use

10 Public Title

Multi-disciplinary Support for Patients with Epilepsy and Psychotropic Drug Use

i Public Title in Chinese 研究名稱

對香港腦癇症患者及精神藥物使用者的多領域專業支緩

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-03

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE Ref. No. 2018.384

14 Medical Condition Being Studied

Epilepsy with psychotropic drug use

15 Intervention

i Types of intervention

Other

Please specify

Questionnaire study

ii Description/ name of Intervention/article

This programme offers a prospective approach to look at the treatment feasibility and pragmatism of antiepileptic treatment-duration that is
tied closely with concurrent cessation of drug-abuse. We shall serve
approximately 120 individual drug-abusers over a period of 3 years who suffer from their first or recurrent seizures. The service will
take place at the Specialist-Outpatient clinic of Prince of Wales Hospital at The Chinese University of Hong Kong in the form of a fasttrack
clinic. The treatment of seizures will be tailor-made to the individual with consideration to the drugs being abused, detoxification plan
and other concurrent medical conditions. The outcome parameters include seizure-free rates, drug compliance, tolerability
profiles and quality of life measures.

iii Dosage form of the intervention

Questionnaire

iv Dosage of the intervention

6 Questionnaires

v Duration of the intervention

1 hour

vi Frequency of the intervention

every 12 months follow up

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Subject aged 18 years or above

2. Subject has a diagnosis of epilepsy or seizure

3. Subject has a medical history of psychotropic drug use

ii Exclusion Criteria

1. Patients is inability to give consent

2. Patients is unwilling to join study

3. Inability to understand Cantonese or English

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-10-26

21 Target Sample Size

120

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Decrease in seizure frequency

ii The metric or method of measurement used

verbal report (Questionnaire)

iii The timepoint(s) of primary interest

12 months

24 Secondary Outcome

i The Name of the outcome

Rehabilitation outcome

ii The metric or method of measurement used

verbal report (Questionnaire)

iii The timepoint(s) of primary interest

12 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-12-07

27 Primary Registry and Trial Identifying Number

ChiCTR1800019016

28 Date of Registration in Primary Registry

2018-10-19

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Trial History Detail on 2019-12-06