Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Vestre Viken Hospital Trust
Sponsor:
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:
NCT01720849
First received: October 31, 2012
Last updated: June 29, 2015
Last verified: June 2015
  Purpose
The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue, micturation and walking impairment under 3 months of Fampyra treatment

Condition Intervention
Multiple Sclerosis
EDSS 4-7
Drug: Fampyra

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Vestre Viken Hospital Trust:

Primary Outcome Measures:
  • change from baseline in visual evoked potential after 2 weeks and 3 months [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fampyra group Drug: Fampyra
The will be given as per normal patient treatment plan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.
Criteria

Inclusion Criteria:

All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.

Exclusion Criteria:

MS patients with contraindications to the compound according to the prescription guidelines.

Patients who have been exposed to Fampyra in the past Patients with an MS attack within last 3 months

  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: NCT01720849

Locations
Norway
Vestre Viken Helseforetak Recruiting
Drammen, Norway, 3004
Contact: Cecilia S Simonsen, MBChB    +4798673256    ceciliasimonsen@yahoo.co.uk   
Sponsors and Collaborators
Vestre Viken Hospital Trust
  More Information

Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT01720849     History of Changes
Other Study ID Numbers: FampyraCSS 
Study First Received: October 31, 2012
Last Updated: June 29, 2015
Health Authority: Norway: Regional Ethics Commitee
Norway: Data Protection Authority

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

ClinicalTrials.gov processed this record on July 21, 2016