Clinical Trials Logo

Clinical Trial Summary

A preliminary assessment of the safety, tolerability and efficacy of Ergoloid mesylates (EM) and 5-hydroxytryptophan (5-HTP) and the combination (EM + 5-HTP) compared to placebo in males aged 18-45 years old with Fragile X Syndrome.


Clinical Trial Description

This single-center, Phase 2, single-blind, 4-period sequential study will obtain a preliminary assessment of the effects of Ergoloid mesylates (EM) 1 mg TID and 5-hydroxytryptophan (5-HTP) 100 mg TID and the combination compared to a placebo period in males aged 18-45 years old with Fragile X Syndrome. The study will consist of a Screening period of up to 28 days prior to initial study drug administration, followed by four 4 week single-blind treatment periods (up to 21 weeks total). The screening and baseline visits may occur at the same time, provided the results of safety labs can be obtained. A final follow-up visit or phone contact for safety is planned one week after the conclusion of Period 4. Safety and tolerability assessments will include adverse event monitoring, vital signs, blood chemistry and hematology, and urinalysis. Brief cognitive and behavioral assessments will be performed during each clinic visit. Eligible participants will progress through each of 4 periods (arms) on study. The periods are not listed sequentially here in order to preserve the single blind for participants. Throughout all 4 periods, participants will take two identical capsules three times a day. If only taking one over-encapsulated drug, they will take one over-encapsulated placebo pill with the drug at each dose, and when in period 4 they will take two over-encapsulated placebo pills at each dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05030129
Study type Interventional
Source Rush University Medical Center
Contact
Status Completed
Phase Phase 2
Start date October 7, 2021
Completion date January 19, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05418049 - Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge Phase 2
Enrolling by invitation NCT01364818 - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment N/A
Completed NCT00965432 - A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107 Phase 1
Completed NCT01120626 - Randomized Controlled Study of Donepezil in Fragile X Syndrome Phase 2
Completed NCT01204151 - Teaching Math Skills to Individuals With Fragile X Syndrome N/A
Active, not recruiting NCT00334971 - Aromatase Activity and Ovarian Growth Factors in African-American Versus Caucasian Women N/A
Enrolling by invitation NCT06139172 - Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities N/A
Recruiting NCT04977986 - Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome Phase 3
Active, not recruiting NCT04698551 - NIPD on cffDNA for Triplet Repeat Diseases
Completed NCT03722290 - Metformin in Children and Adults With Fragile X Syndrome Phase 2
Recruiting NCT05957549 - Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG N/A
Recruiting NCT04141163 - Metformin in Patients With Fragile X Phase 1/Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Completed NCT00858689 - Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome N/A
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Enrolling by invitation NCT03802799 - Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS Phase 2/Phase 3
Recruiting NCT05295277 - Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT01725152 - Ganaxolone Treatment in Children With Fragile X Syndrome Phase 2
Terminated NCT01555333 - An Open Label Extension Study in Subjects With Fragile X Syndrome Phase 3