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Ampligen

Phase 3

Chronic Fatigue Syndrome | Small molecule | Other |AIM ImmunoTech Inc.|Last Updated: Apr 17, 2013

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment234
FDA Designations
ORPHAN_DRUGFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00215800The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue SyndromePHASE3 COMPLETED 234Dec 1, 1998Feb 1, 2004Apr 17, 2013 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AmpligenDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) \> 12 months (Appendix D). 2. Age Range: \> 18 years old, \< 60 years old. 3. Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-...

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