Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)



Status:Recruiting
Conditions:Neurology, Endocrine
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - 80
Updated:12/15/2018
Start Date:February 12, 2018
End Date:December 2021
Contact:Gordon Smith, MD
Email:gordon.smith@vcuhealth.org
Phone:804-828-9556

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Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)

The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate
as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy (CSPN).
Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do
not have an alternative cause for neuropathy will be potentially eligible. The co primary
outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN)
Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase
will last 24 months.


Inclusion Criteria

1. Age 18-80

2. Diagnosis of confirmed cryptogenic symptomatic distal symmetric peripheral
polyneuropathy based on the Toronto consensus criteria for probable neuropathy (the
presence of unequivocal signs and symptoms of neuropathy)

3. Evidence of symptomatic neuropathy based on a screening visit NQOL-DN score of >9

4. Metabolic syndrome based on modified ATPIII criteria, with a BMI ≥ 25 kg/m2. Specific
criteria require 3 of the following 6 to be present at the screening visit.

- Waist circumference >102 cm for men, >88 cm for women

- Serum triglycerides of > 150 mg/dl

- HDL < 40 mg/dl for men, < 50 mg/dl for women

- Those with either a normal HDL or TRG who are taking a lipid lowering medication
for this purpose.

- Blood pressure 130/85 mm Hg or use of anti-hypertension drug

- Prediabetes based on American Diabetes Association (ADA) criteria at screening
based on any one or more of the following: fasting plasma glucose - 100 mg/dL to
125 mg/dL (5.6 mmol/L to 6.9 mmol/L), 2-hour glucose tolerance test - 140 mg/dL
to 199 mg/dL (7.8 mmol/L to 11.0 mmol/L), or hemoglobin A1c between 5.7% and
6.4%.

5. No current or prior history of therapy with topiramate.

6. If female of child-bearing potential (i.e., not surgically sterile or post-menopausal
defined as age > 51 years without menses for ≥ 2 years), negative serum pregnancy test
at screening and negative urine pregnancy test at baseline visit.

7. Women of child-bearing potential or men with sexual partners of childbearing potential
be willing to use an acceptable method of birth control for the duration of the study
and for 12 weeks following completion of study drug therapy. Acceptable methods of
birth control include abstinence, oral contraceptives, the contraceptive patch,
intra-uterine device, the contraceptive ring, and or barrier contraception such as
condoms with spermicide.

Exclusion Criteria

1. CSS-PI clinical determination of an alternative cause for peripheral neuropathy
(including but not limited to rheumatological disorders, Hepatitis B or C, Breast
Cancer treated with neurotoxic chemotherapy within the past 15 years). All potential
subjects will have screening neuropathy labs including assessment for diabetes
(Hemoglobin A1c, oral glucose tolerance test), vitamin B12 level, and immunofixation.

2. Diagnosis of diabetes by history, or screening laboratory results including: HgA1c ≥
6.5%, fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L), or 2-hour oral glucose
tolerance ≥ 200 mg/dL (11.1 mmol/L). Borderline screening labs can be repeated within
two weeks with PPI approval.

3. History of recurrent nephrolithiasis, a single episode of nephrolithiasis within one
year prior to screening, or use of ongoing preventative treatment.

4. Family history of a hereditary neuropathy in a first-degree relative.

5. Severe neuropathy: Utah Early Neuropathy Score > 24 at screening

6. Active foot ulceration or a history of a nontraumatic foot amputation.

7. ECG with QTc more than 450 ms in men, or 470 ms in women.

8. Current or planned therapeutic anticoagulation including coumadin or oral factor X or
thrombin inhibitor therapy (anti-platelet agents are permissible).

9. Chronic corticosteroid use excluding topical or inhaled treatment.

10. Use of a carbonic anhydrase inhibitor (such as acetazolamide) due to risk of
nephrolithiasis.

11. Planned bariatric surgery

12. Use of other weight loss medications.

13. Use of scheduled opiates, or as needed opiate medications more than three times
weekly.

14. Use of topical capsaicin products within 16 weeks of screening or at any time on
study.

15. Medication change for neuropathy symptoms during the 8 weeks prior to screening; or
anticipated change for the duration of study participation.

16. Current use of an intrathecal pain pump or spinal cord stimulator.

17. Screening laboratory creatinine ≥ 2.0 mg/dl.

18. Severe edema, dermatologic or lower extremity condition that would increase risk of
skin biopsy.

19. Major depression, bipolar affective disorder, or other mental health disorders that
are sufficiently severe to increase adverse event risk or impact neuropathy assessment
in the opinion of the responsible site principal investigator.

20. Current suicidal ideation within one year prior to the baseline visit as evidenced by
answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the
Columbia-Suicide Severity Rating Scale (C-SSRS).

21. Ataxia sufficiently severe to represent an unacceptable fall risk in the opinion of
the site principal investigator.

22. A serious medical condition expected to dramatically shorten life span or prevent
participation.

23. Any clinically significant condition or illness, which, in the opinion of the CSS-PI,
would pose a risk to the subject or might confound the study including metabolic
acidosis, bone marrow suppression, blood dyscrasias, bleeding disorder, or closed
angle glaucoma.

24. History of alcohol or drug abuse within the past two years, or existing neuropathy
related to past drug or alcohol abuse.

25. History of malignancy within five years prior to study enrollment, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

26. A history of epilepsy.

27. An inability to understand or cooperate with the procedures of the study

28. Pregnant, or intending to become pregnant, or breastfeeding.
We found this trial at
14
sites
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Gordon Smith, MD
Phone: 804-828-9556
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Eroboghene Ubogu, MD
Phone: 205-975-0445
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Reza Seyedsadjadi, MD
Phone: 617-643-4218
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Mario Saporta, MD, PhD
Phone: 305-243-6725
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Amanda Peltier, MD
Phone: 615-936-0209
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: David Herrmann, MBBCh, MD
Phone: 585-275-1267
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Dianna Quan, MD
Phone: 303-724-6386
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Daniela Menichella, MD, PhD
Phone: 312-503-2128
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Amro Stino, MD
Phone: 614-366-9050
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Lauren Phillips, MD
Phone: 214-648-6329
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Mamatha Pasnoor, MD
Phone: 913-945-9938
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Thomas Brannagan, MD
Phone: 212-305-6036
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Norfolk, Virginia 23510
Principal Investigator: Aaron Vinik, MD,PhD
Phone: 757-446-7976
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Glenn Lopate, MD
Phone: 314-747-8420
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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