Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02511873
Status:
UNKNOWN
Last Update Posted:
2016-01-27
First Post:
2015-07-23
Brief Title:
Fycompa in Subjects With Small Fiber Neuropathy SFN
Sponsor:
PNA Center for Neurological Research
Organization:
PNA Center for Neurological Research
Study Overview
Official Title:
Randomized Crossover Trial of Fycompa in the Treatment of Pain Associated With Small Fiber Neuropathy SFN
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II 2 arm randomized crossover study Subjects will be assigned to either active agent or placebo and then crossover to the other arm This study is designed to evaluate whether Fycompa improves the quality of life in patients with small fiber neuropathy
Detailed Description:
This study will enroll 30 patients from our center alone with a proven SFN diagnosis by a skin biopsy assessment of intraepidermal nerve fiber density The patients must also have a pain score of a least 5 on a VAS Scale Patients will receive Fycompa 2mg tablets Each week patients will be allowed to titrate up by 2mgs up to a maximum dose of 8mg a day This dosing has been used in numerous pain studies when no single dose has been proven to be effective This does not seem to reduce the validity of the placebo phase Patients can choose the dose they feel is best tolerated and most efficacious Once patients choose this dose they will be randomized into two arms Each arm will last 6 weeks Such that patient will receive the dose they chose as most efficacious for 6 weeks or matching placebo for 6 weeks Then each patient will crossover to the other arm Investigator will assess compliance by counting pills at each visit This will provide the ability to see which dose most patients prefer and then study the dose in a blinded randomized fashion There will be 5 office visits and 3 phone visits in the study and Patients will keep a diary of weekly VAS pain scores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None