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

Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Phase 3

Completed

Conditions: Post Herpetic Neuralgia

Interventions: Drug: placebo
Drug: Pregabalin

First Posted Date: 2011-01-05

Last Posted Date: 2021-01-28

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 806

Registration Number: NCT01270828

Locations: 🇺🇸
Integrated Research Center, Inc., San Diego, California, United States
🇺🇸
The Office of Dr. Stephen H. Miller, MD, Las Vegas, Nevada, United States
🇺🇸
Center for Clinical Research, Inc, Carmichael, California, United States

and more 138 locations

Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?

Not Applicable

Conditions: Fibromyalgia

Interventions: Drug: Duloxetine
Drug: Pregabalin

First Posted Date: 2010-12-31

Last Posted Date: 2010-12-31

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Target Recruit Count: 150

Registration Number: NCT01268631

Locations: 🇮🇱
Rheumatology Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Once-A-Day Pregabalin For Partial Seizures

Phase 3

Completed

Conditions: Epilepsies, Partial
Partial Seizures

Interventions: Drug: pregabalin
Drug: placebo

First Posted Date: 2010-12-17

Last Posted Date: 2021-01-25

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 325

Registration Number: NCT01262677

Locations: 🇺🇸
Sarkis Clinical Trials, Gainesville, Florida, United States
🇺🇸
Optima Neurological Services, LLC, Gainesville, Florida, United States
🇺🇸
Mid Atlantic Headache Institute, Pikesville, Maryland, United States

and more 78 locations

Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction

Phase 4

Completed

Conditions: Postoperative Pain Management

Interventions: Drug: Pregabalin

First Posted Date: 2010-11-17

Last Posted Date: 2010-11-17

Lead Sponsor: Prince of Songkla University

Target Recruit Count: 60

Registration Number: NCT01242332

Locations: 🇹🇭
Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand

Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Phase 4

Completed

Conditions: Fibromyalgia

Interventions: Drug: Pregabalin

First Posted Date: 2010-10-22

Last Posted Date: 2012-07-31

Lead Sponsor: Osteoporosis Medical Center, Beverly Hills, CA

Target Recruit Count: 174

Registration Number: NCT01226667

Locations: 🇺🇸
Stuart L Silverman MD Inc., Beverly Hills, California, United States
🇺🇸
Affilaites in Medical Specialty, West Hills, California, United States
🇺🇸
David Silver MD Inc, Beverly Hills, California, United States

and more 2 locations

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

Phase 3

Completed

Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Neuralgia
Pain

Interventions: Drug: pregabalin

First Posted Date: 2010-09-15

Last Posted Date: 2021-01-28

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 104

Registration Number: NCT01202227

Locations: 🇯🇵
Sendai Pain Clinic, Sendai-city, Miyagi, Japan
🇯🇵
Kohnan Hospital, Sendai, Miyagi, Japan
🇯🇵
Kobe Tokushukai Hospital, Kobe, Hyogo, Japan

and more 23 locations