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SPECT : 123 I-FP-CIT and 123I-ADAM

Phase 3

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |ARS Pharmaceuticals, Inc.|Last Updated: May 13, 2015

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01160263Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and ControlsPHASE3 COMPLETED 16Oct 1, 2012Oct 1, 2014May 13, 20152 France
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Study Endpoints
Primary Endpoints
Dopamine transporter binding potential
1 month
Secondary Endpoints
Serotonin transporter binding potential
1 month
Relationships between transporter binding potential and the clinical scores
1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
patients without stiffnessOTHER -
patients with pyramidal stiffnessOTHER -
patients with mixed stiffnessOTHER -
Interventions
NameTypeDescription
SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAMDRUG123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter. 123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter.
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Eligibility Criteria
Age Range39 Years — 66 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Patients (men or women) * between 39 (exclusive) and 66 (inclusive) years old * with a sporadic ALS, defined, probable or laboratory possible * with a disease duration between 3 months (inclusive) and 5 years (exclusive) * treated with rilutek at 100 mg/ day sinc...

Countries:France
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