Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

NCT02259361 | Unknown Phase 4

• 1 other identifier: SHEBA-13-0380-AA-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Nine-Hole Peg Test

  The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function

  Changes in the Nine-Hole Peg Test from Baseline to end of Second week

• Nine-Hole Peg Test

  The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function

  Changes in the Nine-Hole Peg Test from Baseline to end of first week

• Nine-Hole Peg Test

  The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function

  Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase

Secondary Outcomes (12)

• Box and Block test

  Changes in the Box and Block Test from Baseline to end of Second week

• Box and Block test

  Changes in the Box and Block Test from Baseline to end of first week

• Box and Block test

  Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase

• Isometric grip force and motor fatigue

  Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week

• Isometric grip force and motor fatigue

  Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week

Study Arms (2)

Experimental

ACTIVE COMPARATOR

Intervention: Sustained-release oral dalfampridine, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.

Drug: Sustained-release oral dalfampridine

Placebo

PLACEBO COMPARATOR

Placebo, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.

Drug: Placebo

Interventions

Sustained-release oral dalfampridine DRUG

One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.

Also known as: Prolonged-release Fampridine, Ampyra

Experimental

Placebo DRUG

Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.

Also known as: Active comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have the ability to understand the purpose and risks of the study provide a signed and dated informed consent and authorize confidential health information to be examined in accordance with national and local subject privacy regulations.
• The patient must have been diagnosed with clinically definite MS, at the time of informed consent.
• The patient must be between 18-70 years of age, inclusive, at the time of informed consent.
• The patient must have scored between 50 and 90 on the upper limb Motricity Index test, at the time of informed consent. This test evaluates strength during three essential movements (pinch grasp, elbow flexion and shoulder abduction). The selected score range criteria determine patients who suffer a moderate decline in function abilities of the upper limb.

You may not qualify if:

• Onset of multiple sclerosis exacerbation within 60 days of screening.
• History of seizures or evidence of epileptic form activity found on a screened electroencephalogram.
• Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Multiple Sclerosis Center

Tel Litwinsky, Ramat-gan, Israel

Location

Related Publications (6)

• Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.

  PMID: 17401746 BACKGROUND

• Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.

  PMID: 16472864 BACKGROUND

• Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.

  PMID: 19249634 BACKGROUND

• van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.

  PMID: 1510353 BACKGROUND

• Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8. doi: 10.1212/wnl.41.9.1344.

  PMID: 1891078 BACKGROUND

• Menascu S, Frid L, Kalron A. Sustained-release oral dalfampridine appears to have no impact on upper extremity function in people with multiple sclerosis: a randomized controlled trial. Ther Adv Neurol Disord. 2025 Feb 21;18:17562864251321696. doi: 10.1177/17562864251321696. eCollection 2025.

  PMID: 39990866 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anat Achiron, MD, PhD

  Multiple Sclerosis Center, Sheba Medical Hospital

  STUDY DIRECTOR

Central Study Contacts

Shlomo Noy, MD, PhD

CONTACT

972-3-5305284; Shlomo.noy@sheba.health.gov.il

Alon Kalron, PhD

CONTACT

972-2-2436839; alkalron@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 8, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

IL (1)