Therapeutic effect of dalfampridine on patients with Devic syndrome

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210917052506N1

Enrollment

Registered

2021-10-10

Start date

2021-10-23

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Devic. Neuromyelitis optica [Devic]

Interventions

Intervention 1: 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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.;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.;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.;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.	—

Measure

Time frame

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.;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.;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.;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.;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.;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.;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.

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Secondary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirin Pourajam

Esfahan University of Medical Sciences

shirinpourajam@gmail.com+98 31 3233 1062

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026