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

NCT02607254 | Completed Phase 2 Results

• 1 other identifier: IRB00054498
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase

Secondary Outcomes (3)

• Brief Pain Inventory (BPI sf);

  Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase

• Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);

  Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase

• Patient Global Impression of Change (PGIC);

  At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase

Study Arms (2)

Pregabalin Treatment phase

EXPERIMENTAL

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

Drug: Pregabalin

Withdrawal phase

EXPERIMENTAL

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

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin Treatment phase

Placebo DRUG

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

Withdrawal phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Pfizer: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

There were low number of participants due to requirements of the study.

Results Point of Contact

• Title: Dr. Mohammad Khoshnoodi
• Organization: Johns Hopkins University

mkhoshn1@jhmi.edu

410-955-5406

Study Officials

• Mohammad Khoshnoodi, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10

Locations

US (1)