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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01547234
First received: February 23, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Score of hand function tests [ Time Frame: 1,3,4 months after treatment initiation ] [ Designated as safety issue: No ]
    Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.


Secondary Outcome Measures:
  • Improvement in daily function [ Time Frame: 1,3,4 months after treatment initiation ] [ Designated as safety issue: No ]
    Assessment of daily function before treatment with Fampyra and 4 months after initiation of treatment will be compared.

  • Correlation between improvement in manual function and ambulation [ Time Frame: 1,3,4 months after treatment initiation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MS patients visiting the Multiple Sclerosis Clinic at the Carmel Medical Center, Haifa

Criteria

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.

WITHDRAWAL CRITERIA

  1. Participants who decide to withdraw from the study for any reason.
  2. Pregnancy.
  3. Technical problems in performing the tests.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547234

Contacts
Contact: Ariel Miller, MD PhD 972-4-8250851 Ariel_Miller@clalit.org.il
Contact: Lea Marmor, PhD 972-4-8250747 leamarmor@yahoo.com

Locations
Israel
Multiple Sclerosis Center Carmel Medical Center Recruiting
Haifa, Israel
Contact: Lea Marmor, PhD    9724820747    leam@tx.technion.ac.il   
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Ariel Miller, MD,Ph.D Multiple Sclerosis Center Carmel Medical Center
  More Information

No publications provided

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
Study First Received: February 23, 2012
Last Updated: February 25, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Multiple Sclerosis
ambulation
manual function
Fampridine

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

ClinicalTrials.gov processed this record on August 28, 2014