CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Allopregnanolonedrug
Likely dose
Allopregnanolone 2.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02603926
NCT02603926Phase 2Completed
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Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

Randi J. Hagerman, MD·interventional·Posted Nov 13, 2015·Updated Dec 6, 2018

In Brief

A Phase 2 clinical trial evaluating Allopregnanolone for Fragile X-associated Tremor/Ataxia Syndrome. Completed, enrolled 6 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X-associated Tremor/Ataxia Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2016
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.6 years ago

Interventions

Allopregnanolonedrug

Allopregnanolone is an endogenous inhibitory pregnane neurosteroid. It is synthesized from progesterone, and is a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor. Subjects will receive up to 12 infusions in the study. Subjects will all begin with 2.0 mg dosage. If tolerated, the next infusion will be 4.0 mg, and if that is tolerated, the next infusion will be 6.0 mg. Subject infusions will remain stable at the highest dosage tolerated for the remainder of the study. Each infusion will consist of 2.0 mg, 4.0 mg, or 6.0 mg aliquots of the 0.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin with 0.9% sodium chloride injection solution.