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Evaluation of the therapeutic efficacy and safety of dalfampridine on patients with Devic syndrome: A triple-blind randomized clinical trial study

Protocol summary

Study aim
1.Determining the efficacy and safety of Dalfampridine on patients with Devic syndrome 2.Determining and comparing the mean score of Timed 25-foot Walk in Devic patients 3.Determining and comparing the mean score of Lower Extremity Manual Muscle Test in Devic patients 4.Determining and comparing the mean score of the 12-item Multiple Sclerosis Walking Scale in Devic patients 5.Determining and comparing the mean scores of Quality of life, Fatigue, Depression and Anxiety in Devic patients
Design
The placebo group includes 35 patients with Devic, Assigned to this group randomly using table of random numbers treatment group with Dalfampridine includes 35 Devic patients, Assigned to this group with randomly using table of random numbers
Settings and conduct
The study was performed on patients with Devic referred to Isfahan Kashani Hospital in 1400. Patients, physicians visiting patients and statistical analyzers are blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 18 and 65 years, T25FW gait disorder: Test between 5 to 60 seconds, Definitive diagnose of Devic based on Wingerchuc criteria, No other neurological or psychological disorders, No relapse during the three months before the study Exclusion criteria: Patients with any drug side effects during the study such as seizures, kidney failure, anaphylaxis, etc., Patients whose disease worsens so he/she needs aggressive treatment, Unwillingness to cooperate During the study, Incomplete data or death of the patient ,Informed written dissatisfaction, Uncontrolled underlying disease (including kidney failure), Previous diagnose of multiple sclerosis and History of recurrent seizures
Intervention groups
Patients with Devic treated with Dalfampridine 10 mg Twice Daily
Main outcome variables
T25FW score; LEMMT score; MSWS-12 score;SF-36 score; Fatigue score;BDI score; BAI score; EDSS score;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210917052506N1
Registration date: 2021-10-10, 1400/07/18
Registration timing: prospective

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
shirin pourajam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 1062
Email address
shirinpourajam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic efficacy and safety of dalfampridine on patients with Devic syndrome: A triple-blind randomized clinical trial study
Public title
Therapeutic effect of dalfampridine on patients with Devic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 16 to 65 years T25FW-based gait disorder: Test between 5 and 60 seconds Definitive diagnosis of Devic disease based on wingerchuc criteria No other neurological or psychological disease No relapse during the three months prior to enrollment
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, patients were individually divided into two groups by simple random sampling using a table of random numbers. Then one of the two groups was randomly assigned to the intervention group by tossing coin, and the other group was named the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After completing the informed consent form and knowing how to work, patients are randomly assigned to the intervention and placebo groups without knowing the classified group. Visiting physicians also do not know which group the patient is in. Finally, the data analyzer analyzes the data according to the data collected by the researcher without knowing the data group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib st , Isfahan University of Medical Science
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.MUI.MED.REC.1400.349

Health conditions studied

1

Description of health condition studied
Devic
ICD-10 code
G36.0
ICD-10 code description
Neuromyelitis optica [Devic]

Primary outcomes

1

Description
Timed 25-foot Walk score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Examination by T25W table

2

Description
Lower extremity manual muscle test Score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Examination by LEMMT table

3

Description
12-item Multiple Sclerosis Walking Scale Score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Examination by MSWS-12 table

4

Description
Quality of life score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Questionnaire SF-36

5

Description
Depression score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Questionnaire BDI

6

Description
Anxiety score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Questionnaire BAI

7

Description
Disability Status Scale (EDSS)
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Examination, EDSS table

Secondary outcomes

1

Description
Quality of life score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
Questionnaire SF-36

2

Description
Depression score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
BDI Questionnaire

3

Description
Anxiety score
Timepoint
The first visit at the beginning of the study, the second visit in the seventh week, the third visit in the fourteenth week
Method of measurement
BAI Questionnaire

Intervention groups

1

Description
Intervention group: Patients in this group will receive dalfampridine (chemical compound 4-aminopyridine, FDA approved in MS patients, Nano Hayat Daru Co.) at a concentration of 10 mg twice daily. Then the patients' clinical symptoms and drug response will be evaluated in three visits at times of zero, seven and fourteen weeks.
Category
Treatment - Drugs

2

Description
Control group: Recieving placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Ayatollah Kashani Hospital
Full name of responsible person
Shirin Pourajam
Street address
Kashani St, Saheb Rozat St
City
Isfahan
Province
Isfehan
Postal code
818398343
Phone
+98 31 3233 0091
Email
dean@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Pourajam
Street address
Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Pourajam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No. 2, First door on the left, 27th Dead end, Sheikhbahai Street
City
Isfahan
Province
Isfehan
Postal code
8135816868
Phone
+98 31 3233 1062
Fax
Email
shirinpourajam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Pourajam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No. 2, First door on the left, 27th Dead end, Sheikhbahai Street
City
Isfahan
Province
Isfehan
Postal code
8135816868
Phone
+98 31 3233 1062
Fax
Email
shirinpourajam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shirin Pourajam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No. 2, First door on the left, 27th Dead end, Sheikhbahai Street
City
Isfahan
Province
Isfehan
Postal code
8135816868
Phone
+98 31 3233 1062
Fax
Email
shirinpourajam@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data related to the participants will be accessible after being unidentified
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Doctors, Researchers
Under which criteria data/document could be used
The data will be available to improve patients' treatment or further research
From where data/document is obtainable
Dr Shirin Pourajam
What processes are involved for a request to access data/document
Sending an email by the applicant including the details of the person and the reason for the request, review of the email by the executor of the project, if the request is confirmed, the data will be sent
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