Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02259361
• Date of registration: 01/10/2014
• Prospective Registration: Yes
• Primary sponsor: Sheba Medical Center
• Public title: Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
• Scientific title: Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
• Date of first enrolment: November 2014
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02259361
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Israel

Contacts

• Name: Anat Achiron, MD, PhD
• Affiliation: Multiple Sclerosis Center, Sheba Medical Hospital

• Name: Alon Kalron, PhD

• Name: Shlomo Noy, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. The patient must have been diagnosed with clinically definite MS, at the time of
informed consent.

3. The patient must be between 18-70 years of age, inclusive, at the time of informed
consent.

4. 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.

Exclusion Criteria:

1. Onset of multiple sclerosis exacerbation within 60 days of screening.

2. History of seizures or evidence of epileptic form activity found on a screened
electroencephalogram.

3. Changes in concomitant medications to avoid related changes in multiple sclerosis
symptoms during the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: Sustained-release oral dalfampridine

Primary Outcome(s)

Nine-Hole Peg Test [Time Frame: Changes in the Nine-Hole Peg Test from Baseline to end of first week]

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

Nine-Hole Peg Test [Time Frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week]

Secondary Outcome(s)

Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH) [Time Frame: Changes in the DASH Test from Baseline to end of first week]

Isometric grip force and motor fatigue [Time Frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week]

Box and Block test [Time Frame: Changes in the Box and Block Test from Baseline to end of Second week]

Sensory evaluation [Time Frame: Changes in the Sensory evaluation Test from Baseline to end of Second week]

Box and Block test [Time Frame: Changes in the Box and Block Test from Baseline to end of first week]

Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH) [Time Frame: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase]

Box and Block test [Time Frame: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase]

Sensory evaluation [Time Frame: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase]

Sensory evaluation [Time Frame: Changes in the Sensory evaluation Test from Baseline to end of first week]

Isometric grip force and motor fatigue [Time Frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week]

Isometric grip force and motor fatigue [Time Frame: Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase]

Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH) [Time Frame: Changes in the DASH Test from Baseline to end of Second week]

Secondary ID(s)

SHEBA-13-0380-AA-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors