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Pregabalin

Phase 4FDA approved

Dental Anxiety | Small molecule | Psychiatry |Viatris Inc.|Trials Updated: Jan 22, 2021

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 VTRSPhase 2
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-BlindUNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Pregabalin clinical trials

Pregabalin · 1 trial · 1 indication

Phase 2 1
NCT00245609Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental ProcedureDental Anxiety
COMPLETED90 Analytics
PHASE2COMPLETED
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Dental AnxietyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.

Secondary Endpoints

The changes from baseline to endpoint, and changes from baseline to each rating timepoint differ among the three treatment groups for the VAS-Anxiety, VAS-Sedation, Time to Onset of Activity Scales scores, and, Dental Anxiety scales.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
PregabalinDRUG -
AlprazolamDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Male or female outpatients 18 years of age or older who score 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations and have a scheduled appointment for an elective dental procedure. Exclusion Criteria: * Current diagnosis of any of the DSM-IV a...

Countries:GermanyUnited Kingdom
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Frequently asked questions about Pregabalin

What is Pregabalin used for in dental anxiety?

Pregabalin is being studied as an investigational treatment for dental anxiety, the fear or distress patients experience before a dental procedure. Viatris Inc. (VTRS) has evaluated it in a Phase 2 trial in adults with anxiety prior to dental treatment. It is not established as a routine treatment for this indication.

What does Pregabalin target?

Pregabalin targets several calcium channel subunits, including CACNA1H, CACNA2D1, CACNA1C, CACNA2D3, CACNA1S, and CACNA2D2. It acts as a modulator of these targets. This calcium channel activity is the basis for its pharmacological effects in the conditions where it is studied.

Who makes Pregabalin?

Viatris Inc. (ticker VTRS) is the developer associated with this Pregabalin program for dental anxiety. The company is listed as the sponsor of the Phase 2 clinical trial evaluating the drug in this indication.

What phase is Pregabalin in for dental anxiety?

Pregabalin is in Phase 2 development for dental anxiety. The program has one completed Phase 2 trial, and no active trials are currently listed. It remains an investigational use and is not approved for dental anxiety.

What clinical trials is Pregabalin in for dental anxiety?

Pregabalin has been tested in the Phase 2 trial NCT00245609, titled Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure. The completed trial enrolled 90 adults across Germany and the United Kingdom and used a randomized, double-blind design.