Pregabalin

Generic Name: Pregabalin

Brand Names: Lyrica, Pregabalin Accord, Pregabalin Pfizer, Pregabalin Sandoz, Pregabalin Mylan, Pregabalin Zentiva

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₇NO_₂

CAS Number: 148553-50-8

Unique Ingredient Identifier: 55JG375S6M

Background: Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) - an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia among other conditions. Although as per the FDA Label the mechanism of action has not been definitively defined, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels. Pregabalin is marketed by Pfizer under the trade name Lyrica and Lyrica Cr (extended release). It may have dependence liability if misused but the risk appears to be highest in patients with current or past substance use disorders.

Indication: Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.

Associated Conditions: Diabetic Peripheral Neuropathic Pain (DPN), Epilepsies, Fibromyalgia, Generalized Anxiety Disorder, Neuropathic Pain, Partial-Onset Seizures, Peripheral Neuropathic Pain, Peripheral neuropathy, Postherpetic Neuralgia

Associated Therapies: -

Clinical Trials

Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin

Phase 4

Withdrawn

Conditions: Diabetic Polyneuropathy
Postherpetic Neuralgia

Interventions: Drug: Tramadol
Drug: Duloxetine
Drug: Pregabalin

First Posted Date: 2010-05-05

Last Posted Date: 2013-05-31

Lead Sponsor: Turku University Hospital

Registration Number: NCT01116531

Locations: 🇫🇮
Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital, Turku, Finland

Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

Not Applicable

Completed

Conditions: Neuropathic Pain

Interventions: Drug: Placebo
Drug: Pregabalin

First Posted Date: 2010-05-05

Last Posted Date: 2019-04-23

Lead Sponsor: Pfizer

Target Recruit Count: 31

Registration Number: NCT01117766

Locations: 🇬🇧
Pfizer Investigational Site, London, United Kingdom

A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery

Not Applicable

Completed

Conditions: Postoperative Pain

Interventions: Drug: Placebo
Drug: pregabalin

First Posted Date: 2010-04-01

Last Posted Date: 2020-10-28

Lead Sponsor: 59th Medical Wing

Target Recruit Count: 130

Registration Number: NCT01097577

Locations: 🇺🇸
Wilford Hall Medical Center - Refractive Surgery Center, Lackland Air Force Base, Texas, United States

Pregabalin and Colonic Function

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Pregabalin
Other: Bowel preparation

First Posted Date: 2010-03-29

Last Posted Date: 2012-03-07

Lead Sponsor: Mayo Clinic

Target Recruit Count: 62

Registration Number: NCT01094808

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A Study in Painful Diabetic Neuropathy

Phase 3

Completed

Conditions: Diabetic Neuropathy, Painful

Interventions: Drug: Duloxetine
Drug: Pregabalin
Drug: Placebo

First Posted Date: 2010-03-18

Last Posted Date: 2013-01-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 811

Registration Number: NCT01089556

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chorley, United Kingdom