Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Conditions

• Aggressive Behavior in Fragile X Syndome

Eligibility Criteria

Sex

MALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• SRX246 — DRUG
  SRX246 120mg capsules for oral administration
• Placebo — DRUG
  Placebo capsules for oral administration

Study Details

The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS). It will also learn about the safety of drug SRX246. The main questions it aims to answer are: * Does drug SRX246 lower the number of times participants experience IAAS behaviors? * What medical problems do participants have when taking drug SRX246? Researchers will compare drug SRX246 to a placebo (a look-alike substance that contains no drug) to see if drug SRX246 works to treat IAAS behaviors. Participants will: * Take drug SRX246 or a placebo every day for up to 8 months * Have weekly checkups by phone or video to answer study questions * Have periodically scheduled home visits by nurses to conduct medical check-ups and tests * Keep a diary of their symptoms

Key Dates

Start date

Mar 31, 2026

Status verified

Jan 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: SRX246
  SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening.
• Placebo Comparator: Placebo
  Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening.

Primary Outcome Measure

Aberrant Behavior Checklist [ Time Frame: Over an 8 month period ]

Central Contacts

• Neal G Simon, PhD
  610-610-0100
  [email protected]

Locations (3)

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