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Deep Brain Stimulation

Phase 2

Idiopathic Parkinson's Disease | Unknown | Neurology |Boston Scientific Corporation|Last Updated: Feb 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01221948Vercise Implantable Stimulator for Treating Parkinson's DiseasePHASE2 COMPLETED 53 — — Oct 1, 2010Jun 1, 2018Feb 5, 20257 Austria, France +4
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Study Endpoints
Primary Endpoints
Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
26 weeks post first lead implantation

Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.

Secondary Endpoints
Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12 and 52 weeks post first lead implantation
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
12, 26 and 52 weeks post first lead implantation
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
12, 26 and 52 weeks post first lead implantation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Deep Brain StimulationEXPERIMENTALRechargeable Deep Brain Stimulation System
Interventions
NameTypeDescription
Deep Brain StimulationDEVICERechargeable Deep Brain Stimulation System
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Eligibility Criteria
Age Range21 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: 1. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia. 2. Duration of bilateral idiopathic PD of more than five years. 3. Stable medications 4. UPDRS subset III score of ≥30 without medication. 5. ...

Countries:AustriaFranceGermanyItalySpainUnited Kingdom
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