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

Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

Phase 3

Completed

Conditions: Painful Diabetic Peripheral Neuropathy

Interventions: Drug: placebo
Drug: pregabalin

First Posted Date: 2011-10-20

Last Posted Date: 2021-01-28

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

Target Recruit Count: 306

Registration Number: NCT01455415

Locations: 🇺🇸
Chase Medical Research, LLC, Waterbury, Connecticut, United States
🇺🇸
Coastal Connecticut Research, LLC, New London, Connecticut, United States
🇺🇸
Dedicated Clinical Research, Goodyear, Arizona, United States

and more 53 locations

Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

Phase 3

Conditions: Postoperative Pain
Inguinal Hernia

Interventions: Drug: Pregabalin

First Posted Date: 2011-10-12

Last Posted Date: 2011-10-12

Lead Sponsor: University of Malaya

Target Recruit Count: 72

Registration Number: NCT01450345

Locations: 🇲🇾
University Malaya, Kuala Lumpur, Malaysia

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

Phase 3

Completed

Conditions: Fibromyalgia

Interventions: Drug: placebo
Drug: Pregabalin

First Posted Date: 2011-09-12

Last Posted Date: 2021-01-22

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

Target Recruit Count: 197

Registration Number: NCT01432236

Locations: 🇺🇸
Genova Clinical Research, Tucson, Arizona, United States
🇮🇹
Azienda Ospedaliera Luigi Sacco - Polo Universitario, Milano, Italy
🇺🇸
Heartland Research Associates, LLC, Wichita, Kansas, United States

and more 34 locations

Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Pregabalin

First Posted Date: 2011-08-22

Last Posted Date: 2011-08-22

Lead Sponsor: Yuhan Corporation

Target Recruit Count: 28

Registration Number: NCT01420913

Locations: 🇰🇷
Seoul ST.Mary Hospital, Seoul, Korea, Republic of

Pregabalin and Remifentanil - Analgesia and Ventilation

Phase 4

Completed

Conditions: Pain

Interventions: Drug: sugar pill, saline infusion
Drug: Pregabalin
Drug: Remifentanil

First Posted Date: 2011-08-18

Last Posted Date: 2014-09-12

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 12

Registration Number: NCT01419405

Locations: 🇳🇴
Oslo Universitetssykehus, Rikshospitalet, Oslo, Norway

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Phase 4

Withdrawn

Conditions: Fibromyalgia

Interventions: Drug: Pregabalin

First Posted Date: 2011-07-19

Last Posted Date: 2014-04-14

Lead Sponsor: Newton-Wellesley Hospital

Registration Number: NCT01397006

Locations: 🇺🇸
Newton-Wellesley Hospital, Newton, Massachusetts, United States

A Study For Pregabalin In Patients With Fibromyalgia

Phase 3

Completed

Conditions: Fibromyalgia

Interventions: Drug: placebo
Drug: pregabalin

First Posted Date: 2011-07-04

Last Posted Date: 2021-01-28

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

Target Recruit Count: 343

Registration Number: NCT01387607

Locations: 🇨🇳
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
🇨🇳
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing, China
🇨🇳
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China

and more 19 locations