Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis
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.
|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|
- 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.
- 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.
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547234
|Contact: Ariel Miller, MD PhD||972-4-8250851||Ariel_Miller@clalit.org.il|
|Contact: Lea Marmor, PhDfirstname.lastname@example.org|
|Multiple Sclerosis Center Carmel Medical Center||Recruiting|
|Contact: Lea Marmor, PhD 9724820747 email@example.com|
|Principal Investigator:||Ariel Miller, MD,Ph.D||Multiple Sclerosis Center Carmel Medical Center|