Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN) (TopCSPN)
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|ClinicalTrials.gov Identifier: NCT02878798|
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : March 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome||Drug: topiramate Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)|
|Actual Study Start Date :||February 12, 2018|
|Actual Primary Completion Date :||September 28, 2021|
|Actual Study Completion Date :||September 28, 2021|
Placebo Comparator: Placebo
An overencapsulated placebo of identical color, shape and packaging to topiramate will be used.
overencapsulated placebo of identical color, shape and packaging to topiramate
Oral topiramate at a target dose of 50mg twice daily.
Other Name: Topamax
- Intraepidermal nerve fiber density (IENFD) [ Time Frame: Baseline, 32, 64, 96 weeks, Early Termination ]Difference in IENFD change between treatment groups over 96 weeks.
- Norfolk Quality of Life - Diabetic Neuropathy [ Time Frame: Screening, 16, 32, 48, 64, 80, 96 weeks ]Difference in NQOL between treatment groups over 96 weeks.
- Brief pain inventory - diabetic neuropathy (BPI-DN) [ Time Frame: Baseline, 16, 32, 48, 64, 80, 96 weeks, Early Termination ]Pain interference score
- Brief pain inventory - diabetic neuropathy (BPI-DN) [ Time Frame: Baseline, 16, 32, 48, 64, 80, 96 weeks, Early Termination ]Average pain severity
- Utah Early Neuropathy Scale [ Time Frame: Screening, 16, 32, 48, 64, 80, 96 weeks, Early Termination ]Association of UENS
- Sural sensory amplitude (SSA) [ Time Frame: Baseline, 32, 64, 96 weeks, Early Termination ]SSA change
- Peroneal motor conduction velocity (PMCV) [ Time Frame: Baseline, 32, 64, 96 weeks, Early Termination ]PMCV change
- Body mass index (BMI) [ Time Frame: Screening, Baseline, 16, 32, 48, 64, 80, 96 weeks, Early Termination ]BMI change
- Hemoglobin A1C [ Time Frame: Screening, 32, 64, 96 weeks, Early Termination ]A1C change
- Serum Triglycerides (TRG) [ Time Frame: Screening, 32, 64, 96 weeks, Early Termination ]TRG change
- LDL Cholesterol [ Time Frame: Screening, 32, 64, 96 weeks, Early Termination ]LDL change
- HDL Cholesterol [ Time Frame: Screening, 32, 64, 96 weeks, Early Termination ]HDL change
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18-80
- Diagnosis of confirmed symptomatic distal symmetric peripheral polyneuropathy based on the Toronto consensus criteria for probable neuropathy (the presence of unequivocal signs and symptoms of neuropathy)45.
- Evidence of symptomatic neuropathy based on a screening visit NQOL-DN score of >9.
Metabolic syndrome based on modified ATPIII criteria. 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
- Hyperglycemia based on American Diabetes Association (ADA) criteria at screening based on any one or more of the following: fasting plasma glucose > 100 mg/dL (5.6 mmol/L), 2-hour glucose tolerance test > 140 mg/dL (7.8 mmol/L), or hemoglobin A1c > 5.7% .
- No current or prior history of therapy with topiramate.
- 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.
- 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.
- 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 immunofixation47.
- Type I diabetes or current use of insulin or use of insulin in the past 3 months.
- HgA1c > 7.5%. Borderline screening labs can be repeated within two weeks with PPI approval.
- History of recurrent nephrolithiasis, a single episode of nephrolithiasis within one year prior to screening, or use of ongoing preventative treatment.
- Family history of a hereditary neuropathy in a first-degree relative.
- Severe neuropathy: Utah Early Neuropathy Score > 24 at screening
- Active foot ulceration or a history of a nontraumatic foot amputation.
- ECG with QTc more than 450 ms in men, or 470 ms in women.
- Risk of excessive bleeding at the skin biopsy site based on the clinical assessment of the CSS-PI.
- Chronic corticosteroid use excluding topical or inhaled treatment.
- Use of a carbonic anhydrase inhibitor (such as acetazolamide) due to risk of nephrolithiasis.
- Planned bariatric surgery.
- Use of other weight loss medications.
- Use of scheduled opiates, or as needed opiate medications more than three times weekly.
- Use of topical capsaicin products within 16 weeks of screening or at any time on study.
- Medication change for neuropathy symptoms during the 8 weeks prior to screening; or anticipated change for the duration of study participation.
- Current use of an intrathecal pain pump or spinal cord stimulator.
- Screening laboratory creatinine ≥ 2.0 mg/dl.
- Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
- 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.
- 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).
- Ataxia sufficiently severe to represent an unacceptable fall risk in the opinion of the site principal investigator.
- A serious medical condition expected to dramatically shorten life span or prevent participation.
- 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.
- History of alcohol or drug abuse within the past two years, or existing neuropathy related to past drug or alcohol abuse.
- 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.
- A history of epilepsy.
- An inability to understand or cooperate with the procedures of the study.
- Pregnant, or intending to become pregnant, or breastfeeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878798
|Principal Investigator:||Gordon Smith, MD||Virginia Commonwealth University|
Documents provided by Virginia Commonwealth University:
|Responsible Party:||Virginia Commonwealth University|
|Other Study ID Numbers:||
URNN001 / HM20014083
1U01NS095388 ( U.S. NIH Grant/Contract )
|First Posted:||August 25, 2016 Key Record Dates|
|Last Update Posted:||March 9, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Peripheral Nervous System Diseases
Nervous System Diseases
Glucose Metabolism Disorders
Physiological Effects of Drugs