Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

Completed · Phase 2

Conditions studied: Fragile X-associated Tremor/Ataxia Syndrome

In brief

The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).

Key facts

Study ID

NCT02603926

Run by

Randi J. Hagerman, MD

People needed

6

Starts

2015-10-01

Expected to finish

2017-12-01

Last updated by the study team

2018-12-06

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),
• Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the BDS-2 demonstrating executive function deficits.

You may not qualify if…

• other genetic problems in addition to the premutation
• a history of significant brain trauma
• significant substance abuse
• inability to follow the protocol
• liver or kidney disease
• heart failure
• active cancer
• other serious systemic disease
• current use of phenytoin

Where it is running

• UC Davis MIND Institute — Sacramento, California, United States

Full record on ClinicalTrials.gov

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