Neuropathy, Small FiberPhase 2NCT02511873
Fycompa in Subjects With Small Fiber Neuropathy (SFN)
A Phase 2 study testing Fycompa in people with Neuropathy, Small Fiber, run by PNA Center for Neurological Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neuropathy, Small Fiber
- What is being tested?
- Fycompa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
PNA Center for Neurological Research
Phoenix, Arizona, 85018
About this study
Official title: Randomized Crossover Trial of Fycompa in the Treatment of Pain Associated With Small Fiber Neuropathy (SFN)
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.
Read the 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.
- Conditions
- Neuropathy, Small Fiber
- Being tested
- Fycompa, Placebo
- Keywords
- Fycompa, Small Fiber Neuropathy, SFN, Neuropathy, Pain
- Medical subject headings
- Small Fiber Neuropathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FycompaDrug
Also called Perampanel, E2007, AMPA - type Glutamate Receptor Antagonist
Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily
PlaceboDrug
Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily
| Study group | Role | What they receive |
|---|---|---|
| Fycompa | Experimental | Fycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out. Receives: Drug: Fycompa |
| Placebo | Placebo comparator | Inactive ingredient equal to 2mg tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline, Week 5, Week 12 and Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy, Small FiberStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PNA Center for Neurological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Todd Levine, MD, PNA Center for Neurological Research
- Investigators
- Todd Levine, MD, Principal investigator, PNA Center for Neurological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511873
- Sponsor's protocol ID
- FYCOMPA
- Status last verified
- Jan 2016
- First submitted
- 23 Jul 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Trial of Fycompa in the Treatment of Pain Associated With Small Fiber Neuropathy (SFN)
- ClinicalTrials.gov ID
- NCT02511873
- Acronym / sponsor ID
- FYCOMPA
- Conditions
- Neuropathy, Small Fiber
- Keywords
- Fycompa, Small Fiber Neuropathy, SFN, Neuropathy, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PNA Center for Neurological ResearchUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fycompa | Experimental | Drug: FycompaFycompa dose is chosen based on tolerability and efficacy. 2mg to 8mg daily for 6 weeks then washed out. |
| Placebo | Placebo comparator | Drug: PlaceboInactive ingredient equal to 2mg tablets |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FycompaAlso: Perampanel, E2007, AMPA - type Glutamate Receptor AntagonistSubjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily | Drug | Fycompa |
| PlaceboPlacebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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)
Time frame: Baseline, Week 5, Week 12 and Week 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Levine, MD principal investigator
PNA Center for Neurological Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fycompa in people with Neuropathy, Small Fiber, run by PNA Center for Neurological Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.