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HP184

Phase 2

Spinal Cord Injury | Small molecule | Neurology |Sanofi|Trials Updated: Feb 26, 2016

HP184 development status

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

HP184 target and mechanism

ModalitySmall molecule

Also known as Nerispirdine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment698

FDA Designations

No designations recorded

HP184 clinical trials

HP184 · 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 HP184

What is HP184 used for?

HP184 is an investigational small molecule being developed for the treatment of spinal cord injury. It is intended for patients with chronic spinal cord injury, a neurological condition that can result in loss of motor and sensory function. The drug is currently in clinical development, having completed a Phase 2 trial.

Who makes HP184?

HP184 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the research and clinical development of this investigational drug for spinal cord injury.

What phase is HP184 in?

HP184 is in Phase 2 of clinical development. A Phase 2 trial has been completed, but the drug is not yet approved and remains investigational. It is still in the clinical research stage, and further studies may be needed to establish its safety and efficacy.

What clinical trials is HP184 in?

HP184 has one completed clinical trial registered under the identifier NCT00093275. This Phase 2 study, titled 'HP184 in Chronic Spinal Cord Injury Subjects,' enrolled 262 participants across the United States, Australia, Germany, India, and the United Kingdom. The trial was randomized and double-blind.

Is HP184 FDA approved?

HP184 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for spinal cord injury. The drug is still in clinical development, and its safety and efficacy have not been fully established. Regulatory approval has not been granted.