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sNN0031

Phase 1

Parkinson's Disease | Small molecule | Neurology |Medtronic plc.|Last Updated: Jan 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

sNN0031 · 1 trial · 1 indication

Phase 1 1
NCT00866502A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's DiseaseParkinson's Disease
COMPLETED12 Analytics
PHASE1COMPLETED
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability through assessment of adverse events, ECGs, vital signs, clinical laboratory variables, MRI of brain and spinal cord, CSF sampling, and device performance as characterized by catheter tip placement and infusion accuracy.
Multiple over 3 months

Secondary Endpoints

Time course of PD disease activity as measured by the UPDRS, MADRS and MMT rating scales.
Multiple over 3 months
Change in caudate and putamen dopamine turnover using PET scans of 11C-PE2I uptake
Baseline and at 3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
sNN0031EXPERIMENTALContinuous ICV infusion for two weeks at one of three dose levels
PlaceboPLACEBO_COMPARATORContinuous ICV infusion

Interventions

NameTypeDescription
sNN0031DRUGContinuous ICV infusion for two weeks
PlaceboDRUGContinous ICV infusion
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels \>40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral co...

Countries:Sweden
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Frequently asked questions about sNN0031

What is sNN0031 used for in Parkinson's Disease?

sNN0031 is an investigational small molecule being studied for the treatment of Parkinson's Disease. It is administered intracerebroventricularly, meaning directly into the brain's ventricular system. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes sNN0031?

sNN0031 is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug for Parkinson's Disease.

What phase is sNN0031 in?

sNN0031 is in Phase 1 clinical development. A Phase 1 trial has been completed, which was designed to assess the safety and tolerability of the drug when administered intracerebroventricularly to patients with Parkinson's Disease. The drug remains investigational and is not yet approved.

What clinical trials is sNN0031 in?

sNN0031 has one completed clinical trial registered as NCT00866502, titled 'A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease'. This Phase 1 study enrolled 12 participants in Sweden and was placebo-controlled, randomized, and double-blind.

Is sNN0031 the same as any other drug?

No alternative names for sNN0031 have been disclosed. The drug is identified solely by its code name sNN0031 in clinical trial registrations and development documentation. It is being studied specifically for Parkinson's Disease and is not known to be marketed under any other designation.