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 Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study

Phase 4

Terminated

Conditions: Pancreatic Cancer
Visceral Pain

Interventions: Drug: Placebo
Drug: Pregabalin

First Posted Date: 2013-01-16

Last Posted Date: 2017-10-06

Lead Sponsor: Parc de Salut Mar

Target Recruit Count: 20

Registration Number: NCT01768988

Locations: 🇪🇸
Hospital del Mar, Barcelona, Spain

A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

Phase 4

Completed

Conditions: Non-diabetic Painful Peripheral Polyneuropathy
Peripheral Nerve Injury (PNI)
Postherpetic Neuralgia (PHN)

Interventions: Drug: Qutenza
Drug: Pregabalin

First Posted Date: 2012-10-24

Last Posted Date: 2018-04-23

Lead Sponsor: Astellas Pharma Europe Ltd.

Target Recruit Count: 568

Registration Number: NCT01713426

Locations: 🇹🇷
Site 325 Pamukkale University Medical Faculty Hospital, Denizli, Turkey
🇫🇮
Site 163 ORTON Invalidisaatio, Helsinki, Finland
🇬🇷
Site 203 Aretaieio/Maginio Hospital, Athens, Greece

and more 95 locations

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

Phase 3

Completed

Conditions: Neuropathic Pain

Interventions: Drug: placebo
Drug: pregabalin

First Posted Date: 2012-10-05

Last Posted Date: 2021-01-28

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

Target Recruit Count: 542

Registration Number: NCT01701362

Locations: 🇨🇦
Aggarwal and Associates Limited, Brampton, Ontario, Canada
🇺🇸
Chicago Anesthesia Associates, Chicago, Illinois, United States
🇺🇸
Rehabilitation Institute of Chicago, Chicago, Illinois, United States

and more 146 locations

Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Phase 2

Completed

Conditions: Feeling Anxious

Interventions: Drug: hydroxyzine
Drug: Lactose
Drug: Pregabalin

First Posted Date: 2012-08-30

Last Posted Date: 2016-10-11

Lead Sponsor: Poitiers University Hospital

Target Recruit Count: 306

Registration Number: NCT01675986

Locations: 🇫🇷
CHU de POITIERS, Poitiers, France

A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Pregabalin

First Posted Date: 2012-07-10

Last Posted Date: 2013-01-28

Lead Sponsor: GL Pharm Tech Corporation

Target Recruit Count: 30

Registration Number: NCT01635751

Locations: 🇰🇷
The Catholic University of Korea, Seoul St.Mary's Hospital, Seochogu, Seoul, Korea, Republic of

Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Phase 2

Completed

Conditions: Pain
Peripheral Neuropathy

Interventions: Drug: pregabalin
Drug: placebo
Other: questionnaire administration

First Posted Date: 2012-07-10

Last Posted Date: 2018-04-06

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 46

Registration Number: NCT01637077

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
🇺🇸
Essentia Health-Duluth CCOP, Duluth, Minnesota, United States

and more 3 locations