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minocycline

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

minocycline · 1 trial · 1 indication

Phase 2 1
NCT00277355Pilot Study of Minocycline in Huntington's DiseaseHuntington Disease
COMPLETED114 Analytics
PHASE2COMPLETED
Pilot Study of Minocycline in Huntington's Disease
Huntington DiseaseUnlock trial analytics

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 to 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 8 trials (matched to "Huntington Disease")

Frequently asked questions about minocycline

What is minocycline used for in Huntington Disease?

Minocycline is an investigational small molecule being studied for the treatment of Huntington Disease. It is a Phase 2 investigational drug, meaning it is still in clinical development and has not been approved for this use. The completed trial enrolled 114 participants.

Who makes minocycline?

Minocycline is being developed by Merit Medical Systems, Inc., a company traded on the Nasdaq under the ticker MMSI. The company is conducting clinical research to evaluate the drug for Huntington Disease.

What phase is minocycline in?

Minocycline is in Phase 2 clinical development for Huntington Disease. The Phase 2 trial has been completed, and the drug remains investigational. It is not FDA approved for this indication.

What clinical trials is minocycline in?

Minocycline has one completed Phase 2 clinical trial, identified as NCT00277355, titled "Pilot Study of Minocycline in Huntington's Disease." The trial was conducted in the United States and Canada, enrolled 114 participants, and was randomized, double-blind, and placebo-controlled.

Is minocycline the same as minocycline hydrochloride?

Minocycline is the drug name used in the clinical trial for Huntington Disease. The trial does not specify alternative names such as minocycline hydrochloride, so the drug is referred to simply as minocycline in the study context.