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NCT02766517

Biomarker Study in Participants With Migraine

Completed EARLY_PHASE1 Results posted Last updated 9 April 2019
What this trial tests

EARLY_PHASE1 trial testing Capsaicin in Migraine Disorders in 37 participants. Completed in 1 January 2017.

Timeline
28 September 2016
Primary endpoint
1 January 2017
1 January 2017

Quick facts

Lead sponsorEli Lilly and Company
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment37
Start date28 September 2016
Primary completion1 January 2017
Estimated completion1 January 2017
Sites14 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Eligibility, any sex, with Migraine Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Capsaicin-Induced Dermal Blood Flow (DBF) Primary · 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).

GroupValue95% CI
Placebo606.1± 615.6
120 mg Galcanezumab599.5± 514.7
300 mg Galcanezumab689.2± 552.3
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels Primary · 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.

GroupValue95% CI
Placebo1.748± 1.322
120 mg Galcanezumab1.082± 0.261
300 mg Galcanezumab1.370± 0.318

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 3. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 0/19 (0%)
Deaths:
120 mg Galcanezumab
Serious: 0/9 (0%)
Deaths:
300 mg Galcanezumab
Serious: 0/9 (0%)
Deaths:
Other adverse events (9 terms — click to expand)

ReactionSystemPlacebo120 mg Galcanezumab300 mg Galcanezumab
Application site erythemaGeneral disorders
Paraesthesia oralGastrointestinal disorders
PainGeneral disorders
Upper respiratory tract infectionInfections and infestations
HypoaesthesiaNervous system disorders
ParaesthesiaNervous system disorders
ErythemaSkin and subcutaneous tissue disorders
PruritusSkin and subcutaneous tissue disorders
FlushingVascular disorders

Data from ClinicalTrials.gov NCT02766517 adverse events section.

Sponsor's own description

This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Capsaicin

Trials testing the same drug.

Other recruiting trials for Migraine Disorders

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02766517.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing