The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy

NCT02927951 | Completed Phase 3

• 1 other identifier: 10-11-FB-0209
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.

Conditions

Diabetic Peripheral Neuropathy; Nerve Pain

Keywords

Diabetes Mellitus; Peripheral Neuropathy; Diabetic Pain

Outcome Measures

Primary Outcomes (1)

• Decrease in fall risk associated with walking assessed with the Physiological Profile Assesment

  The falls risk will also be ascertained using the long-form Physiological Profile Assessment. The Physiological Profile Assessment has been validated in prospective studies of falls in both community and institutional settings, and predicts those at increased risk of falling with 75-79% accuracy. The Physiological Profile Assessment includes tests of vision (edge contrast sensitivity, high/low contrast visual acuity, depth perception), sensation (ankle touch sensitivity, leg proprioception), leg muscle strength (knee flexion, knee extensors, ankle dorsiflexion), postural sway and postural coordination. Scores from each of these physiologic tests are combined to provide an overall fall risk score that ranges from -2 (very low risk) to +4 (very marked risk).

  Up to 6 months

Secondary Outcomes (3)

• Patient-assessed change in pain intensity assessed with an 11-point scale

  Up to 6 months

• Sleep quality assessed with the Medical Outcomes Study Sleep Scale questionnaire

  Up to 6 months

• Patient Global Impression of Change (PGIC)

  Up to 6 months

Study Arms (2)

pregabalin at 150 mg bid

EXPERIMENTAL

Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Each subject was randomized to the treatment for 6 weeks, followed by a 2 week washout period, and then completed the other arm of the study.

Drug: Placebo

Interventions

Pregabalin DRUG

150mg bid

Also known as: Lyrica

pregabalin at 150 mg bid

Placebo DRUG

150mg bid

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with painful, peripheral neuropathy (ages 40-75 years) and type 2 diabetes (n=40).

You may not qualify if:

• Active ocular or systemic disease
• Recent or recurrent history of musculoskeletal injury,
• Presence of neurological conditions or idiopathic neuropathy
• History of or vertigo
• Use of an aid while walking or difficulty with standing upright
• Visible tremor or uncorrected visual deficits.
• Presence of type 1 diabetes mellitus (defined as C-peptide \< 1 ng/ml or diabetes onset at \< 35 years of age in a non-obese patient).
• Presence of diabetic retinopathy that is more severe than "background" level.
• Presence of diabetic nephropathy
• Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
• Bilateral amputation of lower extremities or foot ulcers involving the great toes.
• Presence of neuroarthropathy (Charcot deformity) is allowable.
• History of major macrovascular events such as myocardial infarction or stroke within the past 6 months.
• Patients with moderate or severe hepatic insufficiency or abnormalities of liver function.
• Presence of significant pedal edema.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Old Dominion University: collaborator

Study Sites (2)

Eastern Virgnia Medical School, Strelitz Diabetes Center

Norfolk, Virginia, 23510f, United States

Location

Strelitz Diabetes Center

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus; Peripheral Nervous System Diseases

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aaron I Vinik, PhD, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research & Neuroendocrine Unit

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)