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

NCT01547234 | Completed

• 2 other identifiers: CMC-11-0081-CTILFAM-MS-2011
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; ambulation; manual function; Fampridine

Outcome Measures

Primary Outcomes (1)

• Score of hand function tests

  Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.

  1,3,4 months after treatment initiation

Secondary Outcomes (2)

• Improvement in daily function

  1,3,4 months after treatment initiation

• Correlation between improvement in manual function and ambulation

  1,3,4 months after treatment initiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Additional CNS co-morbidity.
• Renal failure.
• MS relapse within previous 60 days.
• History of epilepsy or epileptic brain activity on EEG or other conditions which could affect the interpretation of results.
• Clinical problems that cause manual disability in addition to MS.
• WITHDRAWAL CRITERIA
• Participants who decide to withdraw from the study for any reason.
• Pregnancy.
• Technical problems in performing the tests.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Multiple Sclerosis Center Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ariel Miller, MD,Ph.D

  Multiple Sclerosis Center Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multiple Sclerosis & Brain Research Center

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 7, 2012
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

IL (1)