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Xeomin

Phase 3

Chronic Migraine | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment780

FDA Designations

No designations recorded

Clinical trial landscape

Xeomin · 2 trials · 2 indications

Phase 3 2
NCT07018700A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic MigraineEpisodic Migraine
RECRUITING990 Analytics
NCT07018713A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic MigraineChronic Migraine
RECRUITING780 Analytics
PHASE3RECRUITING
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
Episodic MigraineUnlock trial analytics
PHASE3RECRUITING
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
Chronic MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Baseline to month 6

Secondary Endpoints

Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Baseline to month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Xeomin Dose AEXPERIMENTALPlacebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
Xeomin Dose BEXPERIMENTALPlacebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
PlaceboPLACEBO_COMPARATORPlacebo-controlled period: Placebo injections at pericranial and cervical points. Extension period: Xeomin injections at pericranial and cervical points (dose A)

Interventions

NameTypeDescription
XeominDRUGSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
PlaceboDRUGSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites109

Inclusion Criteria: * Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches; * Participan...

Countries:United StatesAustriaCanadaCzechiaDenmarkFranceGermanyItalyPolandSlovakiaSpainSwitzerlandUnited Kingdom
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