Pregabalin

Generic Name
Pregabalin
Brand Names
Lyrica, Pregabalin Accord, Pregabalin Pfizer, Pregabalin Sandoz, Pregabalin Mylan, Pregabalin Zentiva
Drug Type
Small Molecule
Chemical Formula
C8H17NO2
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
-

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-11-04
Last Posted Date
2021-01-25
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
314
Registration Number
NCT00553475
Locations
🇯🇵

Pfizer Investigational Site, Tokushima, Japan

Surgical Pain After Inguinal Hernia Repair (SPAIHR)

First Posted Date
2007-10-30
Last Posted Date
2021-01-25
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
425
Registration Number
NCT00551135
Locations
🇸🇪

Pfizer Investigational Site, Skelleftea, Sweden

Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures

First Posted Date
2007-10-02
Last Posted Date
2021-01-22
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
482
Registration Number
NCT00537940
Locations
🇸🇻

Clinica de Especialidades Neurologicas, San Salvador, El Salvador

🇬🇹

Private Office, Guatemala, Guatemala

🇸🇻

Instituto de Neurociencias, San Salvador, El Salvador

and more 4 locations

Pregabalin Versus Levetiracetam In Partial Seizures

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-10-01
Last Posted Date
2021-01-28
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
509
Registration Number
NCT00537238
Locations
🇻🇪

Pfizer Investigational Site, Caracas, Miranda, Venezuela

Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-03-19
Last Posted Date
2021-01-25
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
54
Registration Number
NCT00448916
Locations
🇺🇸

University of South Alabama, Mobile, Alabama, United States

🇺🇸

St. John's Clinic, Springfield, Missouri, United States

🇺🇸

St. John's Hospital, Springfield, Missouri, United States

and more 15 locations

Efficacy of Pregabalin in Migraine Prevention

Phase 3
Withdrawn
Conditions
First Posted Date
2007-03-14
Last Posted Date
2008-05-09
Lead Sponsor
Hospital Militar del General Luis Felipe Brieba Aran
Target Recruit Count
70
Registration Number
NCT00447369
Locations
🇨🇱

Hospital Militar del General Luis Felipe Brieba Aran, Santiago, Reg. Metropolitana, Chile

Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

First Posted Date
2007-03-02
Last Posted Date
2021-01-22
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
307
Registration Number
NCT00442546
Locations
🇺🇸

Pfizer Investigational Site, Houston, Texas, United States

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

Phase 1
Completed
Conditions
Interventions
First Posted Date
2007-02-19
Last Posted Date
2021-02-11
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
65
Registration Number
NCT00437281
Locations
🇲🇽

Pfizer Investigational Site, Guadalajara, Jalisco, Mexico

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-01-19
Last Posted Date
2021-08-27
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
126
Registration Number
NCT00424372
Locations
🇯🇵

Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo, Japan

🇯🇵

Sapporo Asabu Clinic, Sapporo, Hokkaido, Japan

🇯🇵

Kobayashi Clinic, Urayasu, Chiba, Japan

and more 30 locations

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-12-19
Last Posted Date
2021-02-10
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
356
Registration Number
NCT00413010
Locations
🇺🇦

Pfizer Investigational Site, Lviv, Ukraine

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