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plain crystalline niacin, exercise, sauna

Phase 2

Gulf War Illness | Small molecule | Other |Sage Therapeutics, Inc.|Last Updated: Apr 13, 2020

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01672710Gulf War Illness: Evaluation of an Innovative Detoxification ProgramPHASE2 COMPLETED 32Apr 1, 2010Dec 1, 2015Apr 13, 20201 United States
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Study Endpoints
Primary Endpoints
Short Form-36 for Veterans Quality of Life Physical Component Summary Scores
baseline, 5 weeks

Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average. immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.

Secondary Endpoints
Fatigue Severity
baseline, 5 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
regimen of niacin, exercise, sauna,EXPERIMENTAL4-5 week daily sauna, exercise and niacin with other supplements
waitlistOTHER4 week waitlist with treatment as usual
Interventions
NameTypeDescription
plain crystalline niacin, exercise, saunaDRUGA four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case definition. Exclusion Criteria: * Veterans who meet the inclusion criteria but have been diagnosed by a physician with (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease...

Countries:United States
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