15
Participants
Start Date
October 7, 2021
Primary Completion Date
January 19, 2023
Study Completion Date
January 19, 2023
5-Hydroxytryptophan
5-HTP will be over-encapsulated in identical size 00 capsules. During the 5-HTP Treatment Period (Period 3) and 5-HTP/EM Treatment Period (Period 2), subjects will take 1 capsule of 5-HTP 3 times per day.
Ergoloid Mesylates
Ergoloid mesylates 1 mg will be mixed with methyl cellulose and placed in a size 00 capsule. During the EM Treatment Period (Period 1) and 5-HTP/EM Treatment Period (Period 2), subjects will take 1 capsule of EM 3 times per day.
Matching placebo for Ergoloid mesylates
Matching placebo for Ergoloid mesylates will be ascorbic acid powder in identical size 00 capsules. During the 5-HTP Treatment Period (Period 3) and Placebo Treatment Period (Period 4), subjects will take 1 capsule of matching placebo for EM 3 times per day.
Matching placebo for 5-Hydroxytryptophan
Matching placebo for 5-Hydroxytryptophan will be ascorbic acid powder in identical size 00 capsules. During the EM Treatment Period (Period 2) and Placebo Treatment Period (Period 4), subjects will take 1 capsule of matching placebo for 5-HTP 3 times per day.
Rush University Medical Center, Chicago
Collaborators (1)
FRAXA Research Foundation
OTHER
Purposeful IKE
INDUSTRY
Elizabeth Berry-Kravis
OTHER