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Capsaicin

Phase 1

Migraine Disorders | Small molecule | Neurology |Eli Lilly and Company|Trials Updated: Apr 9, 2019

Capsaicin development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since May 2016

Capsaicin target and mechanism

Molecular targetTRPV1
Target classOpener
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Capsaicin clinical trials

Capsaicin · 1 trial · 1 indication

Early Phase 1 1
NCT02766517Biomarker Study in Participants With MigraineMigraine Disorders
COMPLETED37 Analytics
EARLY_PHASE1COMPLETED
Biomarker Study in Participants With Migraine
Migraine DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

The Capsaicin-Induced Dermal Blood Flow (DBF)
Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993

Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).

Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993

The mean Plasma Calcitonin Gene-Related Peptide levels were reported.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
CapsaicinEXPERIMENTALSingle topical dose of capsaicin

Interventions

NameTypeDescription
CapsaicinDRUGAdministered topically
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo * Have suitable skin characteristics for the dermal capsaicin challenge Exclusion Criteria: * Have a history of significant alle...

Countries:United States
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Frequently asked questions about Capsaicin

What is Capsaicin used for in Migraine Disorders?

Capsaicin is being studied by Eli Lilly and Company as an investigational treatment for migraine disorders. It is in Phase 1 clinical development, with one completed early Phase 1 biomarker study in participants with migraine. It is not an approved migraine therapy.

What does Capsaicin target?

Capsaicin targets TRPV1, the transient receptor potential vanilloid 1 receptor. It acts as a TRPV1 opener, meaning it activates this receptor. TRPV1 is a pain and sensory signaling ion channel, and modulating it is the basis for studying Capsaicin in migraine.

Who makes Capsaicin?

Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of Capsaicin for migraine disorders. The company is responsible for its clinical development program in this indication.

What phase is Capsaicin in?

Capsaicin is in Phase 1 development for migraine disorders. The program includes one completed early Phase 1 trial. As an investigational small molecule, it has not been approved for any migraine indication.

What clinical trials is Capsaicin in?

Capsaicin has been evaluated in one completed clinical trial, NCT02766517, titled Biomarker Study in Participants With Migraine. The early Phase 1 study enrolled 37 participants in the United States. It was an uncontrolled study without randomization or double blinding.