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pregabalin

Phase 4FDA approved

Pain Detection | Small molecule | Pain |Latigo Biotherapeutics, Inc.|Trials Updated: May 4, 2025

pregabalin development status

FDA approval on record Dec 30, 2004
Approval holderUpjohn
ApplicationNDA021446
Highest phase Phase 4 run by Unity Health Toronto (NCT01591980)
Phase scored for LTGOPhase 1
Registered trials 116 across 16 sponsors since Sep 2005

Label indication LYRICA is indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: • Neuropathic pain associated with diabetic…

pregabalin target and mechanism

Molecular targetCACNA1H, CACNA2D1, CACNA1C, CACNA2D3, CACNA1S, CACNA2D2
Target classModulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

pregabalin clinical trials

pregabalin · 1 trial · 2 indications

Early Phase 1 1
NCT06600607Pharmacodynamic Study of 300mg Pregabalin vs Placebo in Healthy Male AdultsPain Detection
COMPLETED20 Analytics
EARLY_PHASE1COMPLETED
Pharmacodynamic Study of 300mg Pregabalin vs Placebo in Healthy Male Adults
Pain DetectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline pain score after dosing with pregabalin vs. placebo
0-12 hours during each treatment period

Numerical Pain Rating Scale (NPRS) will be assessed during Cold Pressor Tests at various time points for time to reach Pain Detection Threshold (PDT) and time to reach Pain Tolerance Threshold (PTT)

Time to reach Pain Detection Threshold (PDT) and Pain Tolerance Threshold (PTT) after dosing with pregabalin vs placebo
0-12 hours during each treatment period

Stopwatches will be used during each cold pressor test to determine time for subject to reach PDT and PTT

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Schedule AOTHERparticipants receive pregabalin 300mg in treatment period 1, and receive placebo in treatment period 2
Schedule BOTHERparticipants receive placebo in treatment period 1, and receive pregabalin 300mg in treatment period 2

Interventions

NameTypeDescription
pregabalin 300 mgDRUGpregabalin is an FDA-approved anticonvulsant medication commonly used to treat nerve pain
PlaceboOTHERbiologically inactive placebo comparator
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male participants aged 18 to 55 years, inclusive, at the time of signing the informed consent. 2. Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opini...

Countries:New Zealand
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