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Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01547234
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : June 28, 2016
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center

Brief Summary:

Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.

Several immunotherapies were developed in the last 10-15 years for the long term management of the relapsing type of disease. Treatment with these drugs decreases disease activity though cannot cure it.

There are few treatments for targeting specific symptoms of MS, such as Provigil for the treatment of fatigue.

Regarding problems related to spasticity and related gait problems , which is stated by over 40 % of MS patients as their main complaint - present treatments include: non-pharmacological treatments such as physiotherapy, occupational therapy, hydrotherapy and pharmacological treatments such as Baclofen, Tizanidine and Botulinium toxin.

Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This drug acts by blocking potassium ion channels and has been proven to improve walking in 35% of the patients after one month of treatment.

The effect of Fampyra on hand function in MS has yet to be studied. The aim of this research project is to assess the effect of treatment with Fampyra on manual function of patients with MS. The investigators hypothesize that through the same mechanism by which Fampyra improves ambulation it can also improve manual function.

MS patients visiting the MS center clinic at the Carmel Medical Center, with walking disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be offered to participate in this study. Participants who agree to participate will be asked to sign a written informed consent. Information regarding their personal and family medical history will be collected via questionnaires. Medical staff will fill clinical questionnaires detailing patient clinical status prior to the study.

Patients will be followed up to 4 months after initiation of treatment with Fampyra. Compliance to treatment will be assessed by collection of the empty vials of the medication.

In each of the follow-up meetings evaluation of manual function, evaluation of ambulation and evaluation of general neurological function will be performed.

Condition or disease
Multiple Sclerosis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 47 participants
Time Perspective: Prospective
Official Title: Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis
Study Start Date : February 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Score of hand function tests [ Time Frame: 1,3,4 months after treatment initiation ]
    Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.

Secondary Outcome Measures :
  1. Improvement in daily function [ Time Frame: 1,3,4 months after treatment initiation ]
    Assessment of daily function before treatment with Fampyra and 4 months after initiation of treatment will be compared.

  2. Correlation between improvement in manual function and ambulation [ Time Frame: 1,3,4 months after treatment initiation ]
    Improvement in patient manual function after 1 to 4 months of initiation of treatment with Fampyra will be compared to patient improvement in ambulation over the same period of time.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS patients visiting the Multiple Sclerosis Clinic at the Carmel Medical Center, Haifa

Inclusion Criteria:

  1. Males and females diagnosed with Multiple Sclerosis.
  2. Over age 18.
  3. Walking disabilities and manual dysfunction.
  4. Willing and able to give inform consent

Exclusion Criteria:

  1. Additional CNS co-morbidity.
  2. Renal failure.
  3. MS relapse within previous 60 days.
  4. History of epilepsy or epileptic brain activity on EEG or other conditions which could affect the interpretation of results.
  5. Clinical problems that cause manual disability in addition to MS.


  1. Participants who decide to withdraw from the study for any reason.
  2. Pregnancy.
  3. Technical problems in performing the tests.

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): NCT01547234

Multiple Sclerosis Center Carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Principal Investigator: Ariel Miller, MD,Ph.D Multiple Sclerosis Center Carmel Medical Center

Responsible Party: Ariel Miller, Director of Multiple Sclerosis & Brain Research Center, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01547234     History of Changes
Other Study ID Numbers: CMC-11-0081-CTIL
FAM-MS-2011 ( Registry Identifier: Fampyra )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Ariel Miller, Carmel Medical Center:
Multiple Sclerosis
manual function

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases