Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy

NCT02607254

Last updated date
Study Location
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Small Fiber Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with idiopathic predominate-small fiber neuropathy

- Subject must have chronic peripheral neuropathic pain for more than 3 months

- A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;

- Show increase in pain intensity scores during the wash off period;

- Age older than 18 years;

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects with large-fiber predominant neuropathy


- Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g.
chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory
neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective
tissue disorders, hepatitis C, Fabry disease, and diabetes;


- Subjects with uncontrolled thyroid or B12 disorders


- Subjects with Complex Regional Pain Syndrome


- Allergy to Pregabalin


- Subjects at risk of suicide or self harm


- Subjects with any clinically unstable cardiovascular, hematological, autoimmune,
endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy,
symptomatic peripheral vascular disease including intermittent claudication,
pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.


- History of known analgesic, alcohol or illicit drug abuse within 12 months of first
visit;


- Pregnant females; breastfeeding females.

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Idiopathic Small Fiber NeuropathyEfficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
NCT02607254
  1. Baltimore, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Official Title  ICMJE Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Brief Summary The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
Detailed Description Patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. Patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. These eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. Patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level > =4 will be considered to have a loss of therapeutic response (LTR).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Small Fiber Neuropathy
Intervention  ICMJE
  • Drug: Pregabalin
    Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.
    Other Name: Lyrica
  • Drug: Placebo
    Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
Study Arms  ICMJE
  • Experimental: Pregabalin Treatment phase
    All patients will be initially treated with pregabalin in a single blind fashion
    Intervention: Drug: Pregabalin
  • Experimental: Withdrawal phase
    After finishing the treatment phase, some patients will be randomized to the placebo or continue on pregabalin for the 4 weeks of withdrawal phase.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
20
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with idiopathic predominate-small fiber neuropathy
  • Subject must have chronic peripheral neuropathic pain for more than 3 months
  • A score >3 and <8 on Pain intensity scale for pain in prior week at first visit;
  • Show increase in pain intensity scores during the wash off period;
  • Age older than 18 years;

Exclusion Criteria:

  • Subjects with large-fiber predominant neuropathy
  • Subjects with HIV infection, trigeminal neuralgia (TGN), toxic neuropathy (e.g. chemotherapy exposure), paraneoplastic neuropathy, mono-gammopathy, inflammatory neuropathy, celiac disease, systemic lupus, peripheral vascular disease, connective tissue disorders, hepatitis C, Fabry disease, and diabetes;
  • Subjects with uncontrolled thyroid or B12 disorders
  • Subjects with Complex Regional Pain Syndrome
  • Allergy to Pregabalin
  • Subjects at risk of suicide or self harm
  • Subjects with any clinically unstable cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, renal, respiratory, or gastrointestinal disease; epilepsy, symptomatic peripheral vascular disease including intermittent claudication, pernicious anemia, untreated hypothyroidism, venous insufficiency, or spinal stenosis.
  • History of known analgesic, alcohol or illicit drug abuse within 12 months of first visit;
  • Pregnant females; breastfeeding females.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607254
Other Study ID Numbers  ICMJE IRB00054498
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Mohammad Khoshnoodi, MDJohns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP