Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
plain crystalline niacin, exercise, sauna · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| regimen of niacin, exercise, sauna, | EXPERIMENTAL | 4-5 week daily sauna, exercise and niacin with other supplements |
| waitlist | OTHER | 4 week waitlist with treatment as usual |
| Name | Type | Description |
|---|---|---|
| plain crystalline niacin, exercise, sauna | DRUG | A 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. |
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...
Plain crystalline niacin, exercise, and sauna is an investigational combination being studied for Gulf War Illness. It is a small molecule regimen evaluated in a Phase 2 clinical trial. The treatment is not approved and remains in clinical development for this condition.
Sage Therapeutics, Inc. (NASDAQ: SAGE) is the developer of plain crystalline niacin, exercise, and sauna. The company is conducting clinical research on this combination for Gulf War Illness.
Plain crystalline niacin, exercise, and sauna is in Phase 2 clinical development. It is an investigational combination therapy for Gulf War Illness and has not been approved by regulatory authorities.
Plain crystalline niacin, exercise, and sauna has one completed clinical trial, NCT01672710, titled 'Gulf War Illness: Evaluation of an Innovative Detoxification Program.' This Phase 2 study enrolled 32 participants in the United States and was a randomized, controlled trial.
Plain crystalline niacin, exercise, and sauna is a combination regimen that includes plain crystalline niacin along with exercise and sauna. It is studied as a combined intervention for Gulf War Illness, not as niacin monotherapy.