Fycompa in Subjects With Small Fiber Neuropathy (SFN)

Neuropathy, Small Fiber Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02511873
• Other study ID #: FYCOMPA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 23, 2015
• Last updated: January 26, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: PNA Center for Neurological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Small Fiber Neuropathy(SFN) proven by skin biopsy assessment of intraepidermal nerve fiber density.

2. Pain scores of at least a 5 on a VAS scale.

3. Male or Female 18 to 60 years old.

4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

5. Stable dose of current pain medication or any medication used for SFN 60 days prior to screening.

6. Women of reproductive age must agree to use double-barrier method of contraception.

Exclusion Criteria:

1. History of intolerance or hypersensitivity to Fycompa.

2. History of psychosis, drug or alcohol abuse within the last 2 years.

3. Malignancy within the last 2 years (except skin cancer).

4. Clinically significant condition (including but not limited to cardiovascular or hepatic diseases and seizure disorders).

5. Pregnant females, breastfeeding females, females of childbearing potential not using effective contraception.

6. Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN.

7. Exclusion medications for this study: Carbamazepine, Carbatrol, Tegretol, Tegretol XR, Equetro, Epitol, Phenytoin, Dilantin, Phenytek, Oxcarbazepine, Trileptal, Rifampin, Refadin, Rimactane and St. John Wort.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erythromelalgia
• Neuropathy, Small Fiber

Intervention

Drug:
• Fycompa
Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily
• Placebo
Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily

Locations

Country	Name	City	State
United States	PNA Center for Neurological Research	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
PNA Center for Neurological Research	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes