Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, C... | NCT01720849

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

NCT01720849

Sponsor

Vestre Viken Hospital Trust

Status

Unknown status

Last Update Posted

Jun 30, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Multiple Sclerosis
EDSS 4-7

Interventions

Fampyra

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 31, 2012

First Submission Date that Met QC Criteria

Nov 1, 2012

First Posted Date

Nov 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2015

Last Update Posted Date

Jun 30, 2015Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Fampyra group			Drug: Fampyra

Name	Type	Description	Arm Group Labels	Other Names
Fampyra	Drug	The will be given as per normal patient treatment plan	Fampyra group

Measure	Description	Time Frame
change from baseline in visual evoked potential after 2 weeks and 3 months		5 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Vestre Viken Helseforetak	Recruiting	Drammen		3004	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided