Back to resultsEfficacy of Dalfampridine on Upper Extremity Function in Patients With MS
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Sustained-release oral dalfampridine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Multiple Sclerosis Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Secondary Outcome Measures
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Isometric grip force and motor fatigue
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
Isometric grip force and motor fatigue
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
Isometric grip force and motor fatigue
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
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
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
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
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
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02259361
Brief Title
Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
Official Title
Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sustained-release oral dalfampridine
Other Intervention Name(s)
Prolonged-release Fampridine, Ampyra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Active comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time Frame
Changes in the Nine-Hole Peg Test from Baseline to end of Second week
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time Frame
Changes in the Nine-Hole Peg Test from Baseline to end of first week
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Time Frame
Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
Secondary Outcome Measure Information:
Title
Box and Block test
Description
The box and blocks test (BBT) examines manual dexterity
Time Frame
Changes in the Box and Block Test from Baseline to end of Second week
Title
Box and Block test
Description
The box and blocks test (BBT) examines manual dexterity
Time Frame
Changes in the Box and Block Test from Baseline to end of first week
Title
Box and Block test
Description
The box and blocks test (BBT) examines manual dexterity
Time Frame
Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
Title
Isometric grip force and motor fatigue
Description
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
Time Frame
Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
Title
Isometric grip force and motor fatigue
Description
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
Time Frame
Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
Title
Isometric grip force and motor fatigue
Description
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
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
Title
Sensory evaluation
Description
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time Frame
Changes in the Sensory evaluation Test from Baseline to end of Second week
Title
Sensory evaluation
Description
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time Frame
Changes in the Sensory evaluation Test from Baseline to end of first week
Title
Sensory evaluation
Description
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Time Frame
Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
Title
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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
Time Frame
Changes in the DASH Test from Baseline to end of Second week
Title
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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
Time Frame
Changes in the DASH Test from Baseline to end of first week
Title
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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
Time Frame
Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomo Noy, MD, PhD
Phone
972-3-5305284
Email
Shlomo.noy@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Kalron, PhD
Phone
972-2-2436839
Email
alkalron@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Achiron, MD, PhD
Organizational Affiliation
Multiple Sclerosis Center, Sheba Medical Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Multiple Sclerosis Center
City
Tel-hashomer
State/Province
Ramat-gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Kalron, PhD
Phone
972-52-2436839
Email
alkalron@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
17401746
Citation
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.
Results Reference
background
PubMed Identifier
16472864
Citation
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.
Results Reference
background
PubMed Identifier
19249634
Citation
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.
Results Reference
background
PubMed Identifier
1510353
Citation
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.
Results Reference
background
PubMed Identifier
1891078
Citation
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.
Results Reference
background
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Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
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