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Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

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ClinicalTrials.gov Identifier: NCT02259361
Recruitment Status : Unknown
Verified October 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Sustained-release oral dalfampridine Drug: Placebo Phase 4

Detailed Description:

Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks potassium channels on demyelinated neurons, allows normal electrical conduction.

Dalfampridine has recently been found to be associated with improvements in visual function, strength, ambulation, fatigue, and endurance in individuals with MS.

Although this medication has a widespread effect, its influence on upper extremity function has never been investigated in a double blind randomized case control study.

Following the fact that during the disease course, approximately 3 out of 4 multiple sclerosis patients encounter upper limb dysfunction the primary objective of this study will be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity function in patients with MS.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
Study Start Date : November 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental
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
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.
Other Names:
  • Prolonged-release Fampridine
  • Ampyra

Placebo Comparator: Placebo
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
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.
Other Name: Active comparator




Primary Outcome Measures :
  1. Nine-Hole Peg Test [ Time Frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week ]
    The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function

  2. Nine-Hole Peg Test [ Time Frame: Changes in the Nine-Hole Peg Test from Baseline to end of first week ]
    The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function

  3. 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 ]
    The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function


Secondary Outcome Measures :
  1. Box and Block test [ Time Frame: Changes in the Box and Block Test from Baseline to end of Second week ]
    The box and blocks test (BBT) examines manual dexterity

  2. Box and Block test [ Time Frame: Changes in the Box and Block Test from Baseline to end of first week ]
    The box and blocks test (BBT) examines manual dexterity

  3. 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 ]
    The box and blocks test (BBT) examines manual dexterity

  4. 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 ]
    Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction

  5. 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 ]
    Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction

  6. 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 ]
    Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction

  7. Sensory evaluation [ Time Frame: Changes in the Sensory evaluation Test from Baseline to end of Second week ]
    The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments

  8. Sensory evaluation [ Time Frame: Changes in the Sensory evaluation Test from Baseline to end of first week ]
    The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments

  9. 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 ]
    The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments

  10. 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 ]
    The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5

  11. 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 ]
    The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5

  12. 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 ]
    The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259361


Contacts
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Contact: Shlomo Noy, MD, PhD 972-3-5305284 Shlomo.noy@sheba.health.gov.il
Contact: Alon Kalron, PhD 972-2-2436839 alkalron@gmail.com

Locations
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Israel
Multiple Sclerosis Center Not yet recruiting
Tel-hashomer, Ramat-gan, Israel
Contact: Alon Kalron, PhD    972-52-2436839    alkalron@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Study Director: Anat Achiron, MD, PhD Multiple Sclerosis Center, Sheba Medical Hospital

Publications:
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02259361     History of Changes
Other Study ID Numbers: SHEBA-13-0380-AA-CTIL
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action