Multiple SclerosisNCT05730738
Dalfampridine in Egyptian Patients With Multiple Sclerosis
A study testing Dalfampridine ER, 10 Mg Oral Tablet, Extended Release in people with Multiple Sclerosis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dalfampridine ER, 10 Mg Oral Tablet, Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Eman Hamid, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Univeristy
Cairo, 11591
Ali Shalash, Professor, 00201111124815, ali-NEURO@YAHOO.COM
AHMED GABER, PROFESSOR, gabarotus@gmail.com
About this study
Official title: Effect of Dalfampridine on Gait Impairment, Cognition and Fatigue in Egyptian Patients With Multiple Sclerosis
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.
Read the 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:
- 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
- Being tested
- Dalfampridine ER, 10 Mg Oral Tablet, Extended Release, Placebo
- Keywords
- Multiple sclerosis,, Dalfampridine, Gait, cognition, Fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalfampridine ER, 10 Mg Oral Tablet, Extended ReleaseDrug
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
PlaceboDrug
placebo similar to Dalfampridine capsule
| Study group | Role | What they receive |
|---|---|---|
| dalfampridine | Active comparator | patients received dalfampridine ER 10mg twice daily Receives: Drug: Dalfampridine ER, 10 Mg Oral Tablet, Extended Release |
| Placebo | Placebo comparator | patients received placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait
Timed 25 foot walk test (25FWT), higher scores mean a worse outcome
Measured: at 3 months
gait
Hauser ambulatory index, higher scores mean a worse outcome
Measured: 3 months
Balance
Berg balance scale, higher scores mean a worse outcome
Measured: 3 months
Secondary outcomes (4)
cognition
Arabic validated version of the BICAM battery
Measured: 3 months
fatigue
Modified fatigue impact scale: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. higher scores mean a worse outcome
Measured: 3 months
cognition
MOCA, higher scores mean a better outcome
Measured: 3 months
Cognition
frontal assessment battery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Jun 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shalash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730738
- Sponsor's protocol ID
- FMASU MD 551/2020
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdeldayem MME, Abdelnasser A, Khalil SH, Hamid E, Abousteit AM, Abushady EM, Shalash A. Effect of Dalfampridine on cognition, gait and fatigue in patients with multiple sclerosis: a randomized placebo-controlled study. Mult Scler Relat Disord. 2026 May;109:107137. doi: 10.1016/j.msard.2026.107137. Epub 2026 Mar 11.
PubMed 41850121
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dalfampridine on Gait Impairment, Cognition and Fatigue in Egyptian Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05730738
- Acronym / sponsor ID
- FMASU MD 551/2020
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis,, Dalfampridine, Gait, cognition, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| dalfampridine | Active comparator | Drug: Dalfampridine ER, 10 Mg Oral Tablet, Extended Releasepatients received dalfampridine ER 10mg twice daily |
| Placebo | Placebo comparator | Drug: Placebopatients received placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalfampridine ER, 10 Mg Oral Tablet, Extended ReleaseThe 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 | Drug | dalfampridine |
| Placeboplacebo similar to Dalfampridine capsule | Drug | Placebo |
Primary outcome
gait
Time frame: at 3 months
Timed 25 foot walk test (25FWT), higher scores mean a worse outcome
gait
Time frame: 3 months
Hauser ambulatory index, higher scores mean a worse outcome
Balance
Time frame: 3 months
Berg balance scale, higher scores mean a worse outcome
4 secondary outcomes
cognition
Time frame: 3 months
fatigue
Time frame: 3 months
cognition
Time frame: 3 months
Cognition
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 41850121Abdeldayem MME, Abdelnasser A, Khalil SH, Hamid E, Abousteit AM, Abushady EM, Shalash A. Effect of Dalfampridine on cognition, gait and fatigue in patients with multiple sclerosis: a randomized placebo-controlled study. Mult Scler Relat Disord. 2026 May;109:107137. doi: 10.1016/j.msard.2026.107137. Epub 2026 Mar 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Hamid, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dalfampridine ER, 10 Mg Oral Tablet, Extended Release in people with Multiple Sclerosis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Shalash, PhD (01111124815, ali_neuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait (time frame: at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.