Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

Multiple Sclerosis Clinical Trial

Official title:

Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02259361
• Other study ID #: SHEBA-13-0380-AA-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 1, 2014
• Last updated: October 5, 2014
• Start date: November 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Sheba Medical Center
• Contact: Shlomo Noy, MD, PhD
• Phone: 972-3-5305284
• Email: Shlomo.noy[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Multiple Sclerosis Center	Tel-hashomer	Ramat-gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View Citation

Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widén 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. Epub 2007 Apr 2. — View 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. Epub 2006 Feb 9. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Box and Block test	The box and blocks test (BBT) examines manual dexterity	Changes in the Box and Block Test from Baseline to end of Second week	No
Secondary	Box and Block test	The box and blocks test (BBT) examines manual dexterity	Changes in the Box and Block Test from Baseline to end of first week	No
Secondary	Box and Block test	The box and blocks test (BBT) examines manual dexterity	Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase	No
Secondary	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	Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week	No
Secondary	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	Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week	No
Secondary	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	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	No
Secondary	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	Changes in the Sensory evaluation Test from Baseline to end of Second week	No
Secondary	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	Changes in the Sensory evaluation Test from Baseline to end of first week	No
Secondary	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	Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase	No
Secondary	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	Changes in the DASH Test from Baseline to end of Second week	No
Secondary	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	Changes in the DASH Test from Baseline to end of first week	No
Secondary	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	Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase	No