Dalfampridine in Egyptian Patients With Multiple Sclerosis

NCT05730738 | Unknown DMC

• 1 other identifier: FMASU MD 551/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis,; Dalfampridine; Gait; cognition; Fatigue

Outcome Measures

Primary Outcomes (3)

• gait

  Timed 25 foot walk test (25FWT), higher scores mean a worse outcome

  at 3 months

• gait

  Hauser ambulatory index, higher scores mean a worse outcome

  3 months

• Balance

  Berg balance scale, higher scores mean a worse outcome

  3 months

Secondary Outcomes (4)

• cognition

  3 months

• fatigue

  3 months

• cognition

  3 months

• Cognition

  3 months

Study Arms (2)

dalfampridine

ACTIVE COMPARATOR

patients received dalfampridine ER 10mg twice daily

Drug: Dalfampridine ER, 10 Mg Oral Tablet, Extended Release

Placebo

PLACEBO COMPARATOR

patients received placebo

Drug: Placebo

Interventions

Dalfampridine ER, 10 Mg Oral Tablet, Extended Release 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

dalfampridine

Placebo DRUG

placebo similar to Dalfampridine capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Univeristy

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Tablets

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Ali Shalash, PhD

CONTACT

01111124815; ali_neuro@yahoo.com

Eman Hamid, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization was done by a research randomization, The copy of the randomization table of patients to the 2 groups was kept with 2 different personnel not working on the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: February 16, 2023
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

EG (1)