Dalfampridine in Egyptian Patients With Multiple Sclerosis

NCT ID: NCT05730738

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-12-01

Brief Summary

The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP). Fampridine penetrates the blood-brain barrier and improves impaired axonal conduction by selectively blocking potassium channels. Moreover, further studies investigated the possible beneficial effect of dalfampridine on cognitive functions and fatigue.

The main objective of this study is to investigate the effect of dalfampridine on gait impairment, cognitive functions and fatigue in a sample of Egyptian patients with multiple sclerosis.

Detailed Description

Type of the Study: randomized double blinded placebo controlled study. Study Setting: MS outpatient clinic in Ain Shams University hospital and Dar Alshefa Hospital, they are located in Eastern Cairo and serves large sector of the ministry of health patients in Greater Cairo.

Period two years. Population patients with relapsing remittent multiple sclerosis attending to ms clinic meeting the inclusion criteria.

Sample size: 100 patients (50 patients in active group and 50 patients in placebo group).

Study Procedures:

Patients diagnosed with MS will be evaluated for inclusion and exclusion criteria using the selected screening scales. Eligible patients will be randomly assigned to one of two groups: dalfampridine ER 10mg twice daily group and placebo group for 12 consecutive weeks.

All patients will be subjected to:

Comprehensive medical history and neurological examination. Demographic information (sex, age and education years), as well as clinical characteristics of them (age at onset, duration of illness, onset of last relapse, received DMD and other medications during the study).

MRI brain and spine lesions (site & number of lesions). Check list for side effects of dalfampridine. Expanded Disability Status Scale (EDSS) (Kurtzke, 1983). The Patient Health Questionnaire (PHQ-9) Arabic translation (Kroenke et al., 2001).

Gait assessment by:

• Timed 25 foot walk test (25FWT) (Motl et al., 2017).
• Hauser ambulatory index (Hauser et al., 1983).
• Berg balance scale (Berg et al., 1992).
• Falls in last 2 weeks.

Cognitive assessment by:

• Arabic validated version of the BICAM battery, which compromised the symbol digit modality test (SDMT, information processing speed), verbal learning test (VLT, verbal memory) and brief visuospatial memory teat revised (BVMT-R, visual memory) (Alboudi et al., 2020).
• Montreal Cognitive Assessment (MoCA) Arabic version (Abd El-Rahman and El-Gaafary, 2009).
• Frontal assessment battery (FAB) (for executive functions) (Dubois and Litvan, 2000).

Fatigue assessment by:

o Modified fatigue impact scale (MFIS) in last 4 weeks Arabic version (Farran et al., 2020).

• Assessment for gait, cognition and fatigue will be done at baseline and after 12 weeks of treatment by a blinded rater.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dalfampridine

patients received dalfampridine ER 10mg twice daily

Group Type: ACTIVE_COMPARATOR

Dalfampridine ER, 10 Mg Oral Tablet, Extended Release

Intervention Type: DRUG

The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP). Fampridine penetrates the blood-brain barrier and improves impaired axonal conduction by selectively blocking potassium channels

Placebo

patients received placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo similar to Dalfampridine capsule

Interventions

Dalfampridine ER, 10 Mg Oral Tablet, Extended Release

The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP). Fampridine penetrates the blood-brain barrier and improves impaired axonal conduction by selectively blocking potassium channels

Intervention Type: DRUG

Placebo

placebo similar to Dalfampridine capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 18 years.
• Individuals diagnosed with RRMS based on revised McDonald Criteria 2017
• Patients with Expanded Disability Status Scale (EDSS) ≤ 5.5
• Patients with gait impairment according to 25 foot walk test (25FWT) with cutoff ≥ 4 seconds

Exclusion Criteria

• Women who are pregnant, intended to be pregnant or breastfeeding.
• Past History of epilepsy or trigeminal neuralgia.
• History of any psychiatric or medical illness affecting cognition and fatigue.
• Other comorbidities that might affect gait.
• Clinical relapse in the last three months.
• Uncooperative patients or couldn't perform the required scales.
• Patients with moderate to severe depression according to patient health questionnaire (PHQ-9) with cutoff point ≥15.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ali Shalash

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams Univeristy

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali Shalash, PhD

Role: CONTACT

ali_neuro@yahoo.com

01111124815

Eman Hamid, MD

Role: CONTACT

Facility Contacts

Ali Shalash, Professor

Role: primary

ali-NEURO@YAHOO.COM

00201111124815

AHMED GABER, PROFESSOR

Role: backup

gabarotus@gmail.com

Other Identifiers

FMASU MD 551/2020

Identifier Type: -

Identifier Source: org_study_id