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Trial record 1 of 1 for:    NCT02607254
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Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy

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ClinicalTrials.gov Identifier: NCT02607254
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 18, 2015
Results First Submitted Date  ICMJE August 10, 2018
Results First Posted Date  ICMJE October 4, 2018
Last Update Posted Date October 4, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
Visual Analogue Score for Pain Intensity. [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
Pain intensity scores [ Time Frame: 12 weeks ]
The primary outcome is change in pain intensity score after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Brief Pain Inventory (BPI sf); [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]
    Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.
  • Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]
    a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.
  • Patient Global Impression of Change (PGIC); [ Time Frame: At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]
    patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • Brief Pain Inventory (BPI sf); [ Time Frame: 12 weeks ]
  • Daily Sleep Interference Rating Scale (SIRS); [ Time Frame: 12 weeks ]
  • Patient Global Impression of Change (PGIC); [ Time Frame: 12 weeks ]
  • Small Fiber Neuropathy Symptom Inventory Questionnaire (SFN-SIQ); [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MD Johns 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