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Nerispirdine

Phase 2

Multiple Sclerosis | Small molecule | Neurology |Sanofi|Trials Updated: Feb 26, 2016

Nerispirdine development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Oct 2004

Nerispirdine target and mechanism

Molecular targetKCNQ1, KCND3, KCNH2, KCNA2, KCNA1, KCNQ2
Target classBlocker
ModalitySmall molecule

Also known as HP184

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment698

FDA Designations

No designations recorded

Nerispirdine clinical trials

Nerispirdine · 3 trials · 4 indications

Phase 2 3
NCT00811902Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple SclerosisMultiple Sclerosis
COMPLETED405 Analytics
NCT00772525Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple SclerosisMultiple Sclerosis
COMPLETED31 Analytics
NCT00093275HP184 in Chronic Spinal Cord Injury SubjectsSpinal Cord Injury
COMPLETED262 Analytics
PHASE2COMPLETED
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
Multiple SclerosisUnlock trial analytics
PHASE2COMPLETED
Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis
Multiple SclerosisUnlock trial analytics
PHASE2COMPLETED
HP184 in Chronic Spinal Cord Injury Subjects
Spinal Cord InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
14 weeks
Visual Evoked Potential (P100) latency
pre-dose and post-dose of each treatment intake (3)
Change from baseline in total motor score of American Spinal Injury Association (ASIA) manual motor test at Week 24.

Secondary Endpoints

Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
14 weeks
Pelli-Robson Contrast Sensitivity Score
pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
pre-dose and post-dose of each treatment intake (3)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nerispirdine 50mgEXPERIMENTALNerispirdine 50mg once daily for 14 weeks
Nerispirdine 100mgEXPERIMENTALNerispirdine 100mg once daily for 14 weeks
Nerispirdine 200mgEXPERIMENTALNerispirdine 200mg once daily for 14 weeks
PlaceboPLACEBO_COMPARATORPlacebo for Nerispirdine once daily for 14 weeks
Sequence 1EXPERIMENTALplacebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Sequence 2EXPERIMENTALplacebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Sequence 3EXPERIMENTAL50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Sequence 4EXPERIMENTAL50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3
Sequence 5EXPERIMENTAL400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Sequence 6EXPERIMENTAL400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3

Interventions

NameTypeDescription
NerispirdineDRUGtablet, oral administration
placeboDRUGtablet, oral administration
HP184DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Clinically definite MS (according to McDonald criteria), Exclusion Criteria: * Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit. * Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assist...

Countries:United StatesCanadaFinlandFranceGermanyNorwaySpainAustraliaIndiaUnited Kingdom
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Frequently asked questions about Nerispirdine

What is nerispirdine?

Nerispirdine is an investigational small molecule developed by Sanofi for multiple sclerosis. It is a potassium channel blocker that has been studied in Phase 2 clinical trials. It is not approved for any indication and remains in clinical development.

What is nerispirdine used for in multiple sclerosis?

Nerispirdine was studied as a treatment for multiple sclerosis, including patients with optic nerve involvement such as neuritis. Both Phase 2 trials enrolled adults with MS. It is investigational and has not been approved for treating multiple sclerosis or any other condition.

What does nerispirdine target?

Nerispirdine is a blocker of several potassium channels, specifically KCNQ1, KCND3, KCNH2, KCNA2, KCNA1, and KCNQ2. By blocking these channels, it is designed to modulate nerve signal conduction, which is the rationale for studying it in multiple sclerosis.

Who makes nerispirdine?

Nerispirdine is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored both Phase 2 trials of the drug in multiple sclerosis.

What phase is nerispirdine in?

Nerispirdine is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is nerispirdine in?

Nerispirdine has been evaluated in two completed Phase 2 trials. NCT00811902 tested efficacy, safety, and tolerability in 405 patients with multiple sclerosis across the United States, Canada, and several European countries. NCT00772525 studied single oral doses and visual function in 31 patients with multiple sclerosis and optic neuritis in the United States.