NCT02511873

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

July 23, 2015

Last Update Submit

January 26, 2016

Conditions

Neuropathy, Small Fiber

Keywords

FycompaSmall Fiber NeuropathySFNNeuropathyPain

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, Week 5, Week 12 and Week 18

Secondary Outcomes (1)

  • 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)

    Baseline, Week 5, Week 12 and Week 18

Study Arms (2)

Fycompa

EXPERIMENTAL

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

Drug: Fycompa

Placebo

PLACEBO COMPARATOR

Inactive ingredient equal to 2mg tablets

Drug: Placebo

Interventions

FycompaDRUG

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

Also known as: Perampanel, E2007, AMPA - type Glutamate Receptor Antagonist
Fycompa
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Subjects with renal impairment or on hemodialysis or who have hepatic impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNA Center for Neurological Research

Phoenix, Arizona, 85018, United States

Location

MeSH Terms

Conditions

Small Fiber NeuropathyPain

Interventions

perampanel

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Todd Levine, MD

    PNA Center for Neurological Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 30, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

US(1)