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Fycompa in Subjects With Small Fiber Neuropathy (SFN)

Primary Purpose

Neuropathy, Small Fiber

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fycompa

Placebo

About this trial

This is an interventional treatment trial for Neuropathy, Small Fiber focused on measuring Fycompa, Small Fiber Neuropathy, SFN, Neuropathy, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density.
Pain scores of at least a 5 on a VAS scale.
Male or Female 18 to 60 years old.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Stable dose of current pain medication or any medication used for SFN 60 days prior to screening.
Women of reproductive age must agree to use double-barrier method of contraception.

Exclusion Criteria:

History of intolerance or hypersensitivity to Fycompa.
History of psychosis, drug or alcohol abuse within the last 2 years.
Malignancy within the last 2 years (except skin cancer).
Clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders).
Pregnant females, breastfeeding females, females of childbearing potential not using effective contraception.
Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN.
Exclusion medications for this study: Carbamazepine, Carbatrol, Tegretol, Tegretol XR, Equetro, Epitol, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Refadin, Rimactane and St. John Wort.
Subjects with renal impairment or on hemodialysis or who have hepatic impairment.

Sites / Locations

PNA Center for Neurological Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fycompa

Placebo

Arm Description

Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out.

Inactive ingredient equal to 2mg tablets

Outcomes

Primary Outcome Measures

To Assess the Change of Pain Symptoms Upon Treatment of Fycompa in Comparison to Placebo using Visual Analog Scale (VAS) andBrief Pain inventory(BPI) Short Form

Secondary Outcome Measures

To Assess improvement of Quality of Life Upon Treatment of Fycompa in Comparison to Placebo using Neuro QOL Lower Extremity Function Scale, Patient Global impression of Change (PGIC) Scale and Treatment Satisfaction Questionnaire for Medication (TSQM)

Full Information

NCT ID

NCT02511873

First Posted

July 23, 2015

Last Updated

January 26, 2016

Sponsor

PNA Center for Neurological Research

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02511873

Brief Title

Fycompa in Subjects With Small Fiber Neuropathy (SFN)

Official Title

Randomized Crossover Trial of Fycompa in the Treatment of Pain Associated With Small Fiber Neuropathy (SFN)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

PNA Center for Neurological Research

Collaborators

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathy, Small Fiber

Keywords

Fycompa, Small Fiber Neuropathy, SFN, Neuropathy, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fycompa

Arm Type

Experimental

Arm Description

Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Inactive ingredient equal to 2mg tablets

Intervention Type

Drug

Intervention Name(s)

Fycompa

Other Intervention Name(s)

Perampanel, E2007, AMPA - type Glutamate Receptor Antagonist

Intervention Description

Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily

Primary Outcome Measure Information:

Title

To Assess the Change of Pain Symptoms Upon Treatment of Fycompa in Comparison to Placebo using Visual Analog Scale (VAS) andBrief Pain inventory(BPI) Short Form

Time Frame

Baseline, Week 5, Week 12 and Week 18

Secondary Outcome Measure Information:

Title

Time Frame

Baseline, Week 5, Week 12 and Week 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density. Pain scores of at least a 5 on a VAS scale. Male or Female 18 to 60 years old. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Stable dose of current pain medication or any medication used for SFN 60 days prior to screening. Women of reproductive age must agree to use double-barrier method of contraception. Exclusion Criteria: History of intolerance or hypersensitivity to Fycompa. History of psychosis, drug or alcohol abuse within the last 2 years. Malignancy within the last 2 years (except skin cancer). Clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders). Pregnant females, breastfeeding females, females of childbearing potential not using effective contraception. Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN. Exclusion medications for this study: Carbamazepine, Carbatrol, Tegretol, Tegretol XR, Equetro, Epitol, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Refadin, Rimactane and St. John Wort. Subjects with renal impairment or on hemodialysis or who have hepatic impairment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd Levine, MD

Organizational Affiliation

PNA Center for Neurological Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

PNA Center for Neurological Research

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

12. IPD Sharing Statement

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Fycompa in Subjects With Small Fiber Neuropathy (SFN)

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