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Nerispirdine

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment436

FDA Designations

No designations recorded

Clinical trial landscape

Nerispirdine · 2 trials · 3 indications

Phase 2 2
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
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

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)

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
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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 StatesCanadaFinlandFranceGermanyNorwaySpain
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Frequently asked questions about Nerispirdine

What is Nerispirdine used for?

Nerispirdine is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is in Phase 2 clinical development and has been evaluated in patients with this condition, including those with optic nerve involvement. Nerispirdine is not approved and remains under clinical investigation.

Who makes Nerispirdine?

Nerispirdine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with Multiple Sclerosis.

What phase is Nerispirdine in?

Nerispirdine is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total of 436 participants enrolled. The drug is investigational and has not been approved for any use. Both trials were randomized, double-blind, and placebo-controlled.

What clinical trials is Nerispirdine in?

Nerispirdine has been studied in two completed Phase 2 trials. NCT00772525 evaluated single oral doses on visual function in 31 patients with Multiple Sclerosis and optic neuritis. NCT00811902 assessed efficacy, safety, and tolerability in 405 patients with Multiple Sclerosis across multiple countries.

Is Nerispirdine the same as other drugs for Multiple Sclerosis?

Nerispirdine is a distinct investigational small molecule developed by Sanofi. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly detailed, and it is being studied specifically for its potential effects in Multiple Sclerosis.