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

Primary Purpose

Idiopathic Small Fiber Neuropathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Small Fiber Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pregabalin Treatment phase

Withdrawal phase

Arm Description

All patients will be initially treated with pregabalin in a single blind fashion

After finishing the treatment phase, some patients will be randomized to the placebo or continue on pregabalin for the 4 weeks of withdrawal phase.

Outcomes

Primary Outcome Measures

Visual Analogue Score for Pain Intensity.
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.

Secondary Outcome Measures

Brief Pain Inventory (BPI sf);
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);
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);
patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.

Full Information

First Posted
November 16, 2015
Last Updated
October 1, 2018
Sponsor
Johns Hopkins University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02607254
Brief Title
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Official Title
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Small Fiber Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin Treatment phase
Arm Type
Experimental
Arm Description
All patients will be initially treated with pregabalin in a single blind fashion
Arm Title
Withdrawal phase
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
Primary Outcome Measure Information:
Title
Visual Analogue Score for Pain Intensity.
Description
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.
Time Frame
Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Secondary Outcome Measure Information:
Title
Brief Pain Inventory (BPI sf);
Description
Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.
Time Frame
Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Title
Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);
Description
a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.
Time Frame
Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
Title
Patient Global Impression of Change (PGIC);
Description
patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.
Time Frame
At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Khoshnoodi, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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