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minocycline

Phase 2

Huntington Disease | Small molecule | Rare Disease |Merit Medical Systems, Inc.|Last Updated: Apr 19, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00277355Pilot Study of Minocycline in Huntington's DiseasePHASE2 COMPLETED 114Apr 1, 2006Nov 1, 2008Apr 19, 201312 United States, Canada
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Study Endpoints
Primary Endpoints
Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]
Baseline to 18 months

Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale \[UHDRS\] between baseline \& Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).

Secondary Endpoints
Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]
Baseline to 18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MinocyclineEXPERIMENTALMinocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration.
Matching placeboPLACEBO_COMPARATORSugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.
Interventions
NameTypeDescription
minocyclineDRUGMinocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart)
Matching placeboDRUGMatching placebo 1 capsule twice daily, 18 months treatment duration.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Age 18 years or older * Clinical features of HD and a confirmatory family history of HD; and/or genetically confirmed HD * Independently walking and fully self-sufficient in activities of daily living (eating, dressing, bathing) * Able to take medication (capsules) by mouth E...

Countries:United StatesCanada
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Competitive Landscape -Huntington's Disease 9 trials