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Trial record 19 of 424 for:    Pregabalin

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

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.

Condition or disease Intervention/treatment Phase
Idiopathic Small Fiber Neuropathy Drug: Pregabalin Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
Study Start Date : September 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin Treatment phase
All patients will be initially treated with pregabalin in a single blind fashion
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

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.
Drug: Placebo
Placebo will be given to the patients that are randomized to placebo during withdrawal phase.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02607254


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Pfizer
Investigators
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Principal Investigator: Mohammad Khoshnoodi, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02607254     History of Changes
Other Study ID Numbers: IRB00054498
First Posted: November 18, 2015    Key Record Dates
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Pregabalin
Neuralgia
Small Fiber Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs