Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): 5-Hydroxytryptophan / Vitamin B6; Ergoloid Mesylate; Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): 5-hydroxytryptophan, also known as 5-HTP has a nutraceutical status and has never been approved as a drug for any indication, but as a dietary supplement has been used extensively for several disorders for many years such as in the therapy of depression, fibromyalgia, obesity, insomnia and chronic headache; Ergoloid Mesylates, trade name Hydergine, is a mixture of the methanesulfonate salts of three dihydrogenated ergot alkaloids, dihydroergocristine, dihydroergocornine, and alpha- and beta-dihydroergocryptine. Ergot alkaloids are dopamine agonists which activate dopamine receptors (in the basal ganglia and other parts of the brain involved in motor function) and a prolactin inhibitor. Ergot is a strong vasoconstrictor and thus helps to reduce bleeding by narrowing of the blood vessels.; Placebo capsules
Intervention MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine; Ergoloid Mesylates; 5-Hydroxytryptophan; Dihydroergotoxine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment