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TerminatedNCT01555333209FX303Updated Jul 31, 2013

An Open Label Extension Study in Subjects With Fragile X Syndrome

A Phase 3 interventional study of arbaclofen in Fragile X Syndrome, sponsored by Seaside Therapeutics, Inc.. Terminated at 23 sites in United States. Open to participants aged 5 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-07-31.

Sponsored by Seaside Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
357
Allocation
Not applicable
Ages
5 Years to 50 Years
Sex
All
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Study summary

This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen).

Read the detailed description

Three studies sponsored by Seaside Therapeutics, Inc., are currently evaluating the efficacy of STX209 for management of typical problem behaviors in subjects with FXS. These are Study 209FX301, "A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Adolescents and Adults with Fragile X Syndrome;" Study 209FX302, "A Randomized, Double-Blind, Placebo-Controlled, Fixed- Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Children with Fragile X Syndrome;" and Study 22002, "An Open-Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Fragile X Syndrome." This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 22002 into a long-term, open-label study. The open-label extension protocol will provide data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions reflective of their typical medical care rather than in their previously completed study.

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Conditions studied

  • Fragile X Syndrome
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In context

Fragile X Syndrome

110 studies on the registry are indexed under Fragile X Syndrome; 23 are open to participants now.

This study's enrollment of 357 is above the median of 58 across 88 interventional studies indexed under Fragile X Syndrome.

Browse Fragile X Syndrome studies →

Lead sponsor

Seaside Therapeutics, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Successfully completed all scheduled visits of the previous protocol ( 22002, 209FX301, or 209FX302).
  2. A parent,LAR, or caregiver must be willing and able to accompany the subject to all study visits, participate in phone calls, complete study assessments, administer study medication, and report the subject's condition and medication use to site staff members.
  3. Prior to the conduct of any study-specific procedures, the subject must provide written informed consent to participate in the study ( if developmentally appropriate) or verbal assent and the parent/caregiver/LAR must provide written informed consent. If the caregiver attending the clinic visits is not the parents, caregiver, or LAR, written consent must also be obtained for the caregiver's participation in the study.
  4. Current treatment with no more than 3 psychoactive medications, including anti-epileptics, unless the Medical Monitor is consulted.
  5. Subjects with a history of seizure disorder must have been seizure free for 6 months and be taking anti-epileptics, or seizure free for 3 years if not receiving anti-epileptic treatment. If currently receiving treatment with anti-epileptics, serum concentration levels must be tested and be in therapeutic range.
  6. Negative pregnancy test for females of childbearing potential or be using a medically acceptable form of birth control.

Exclusion criteria

Exclusion Criteria

  1. Subjects with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
  2. Subjects who are currently engaged in illicit drug or alcohol abuse.
  3. Subjects who had a serious adverse event (SAE) while taking STX209 during their previous protocol (22002,209FX301,309FX302)that the Investigator considered related to STX209, unless approval from the Medical Monitor is obtained.
  4. The occurrence or continuation of any AE or condition during Studies 22002, 209FX301, or 209FX302 that, in the opinion of the Investigator, should exclude this subject from participating in the open-label extension.
  5. Subjects taking another investigational drug, other than STX209, currently or within 30 days of Visit 1. Subject must not take any investigational drugs during this study.
  6. Subjects who, in the Investigator's opinion, might not be suitable for the study.
  7. Subjects treated with vigabatrin, tiagabine, or riluzole currently or within 2 weeks of Visit 1.
  8. Subjects treated with racemic baclofen currently or within 1 week of Visit 1.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
357 participants (actual)

Study arms

  • Experimental
    Arbaclofen

    Open Label Study

    Drug: arbaclofen

Interventions

  • Drugarbaclofen

    A flexible dose titration will be utilized. Orally disintegrating tablets

    Also known as: STX209

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What researchers measure

Primary outcomes

  1. Safety Measures

    Adverse Events, Suicidality Assessment, Physical Examination, Vital Signs and Weight, Laboratory Tests: Complete Blood Count, Urinalysis, Chemistry Panel

    Time frame: 100 weeks

Secondary outcomes

  1. Efficacy

    Aberrant Behavior Checklist Lethargy/Social Withdrawal Sub- Scale Clinical Global Impression Vineland Adaptive Behavior Scales Stanford Binet Intelligence Scale

    Time frame: 100 Weeks

07

Study locations

23 sites
  • Seaside Therapeutics Site #16
    Phoenix, Arizona 85006, United States
  • Seaside Therapeutics Site #07
    Long Beach, California 90806, United States
  • Seaside Therapeutics Site #10
    Sacramento, California 95817, United States
  • Seaside Therapeutics Site #17
    Aurora, Colorado 80045, United States
  • Seaside Therapeutics Site #01
    Miami, Florida 33136, United States
  • Seaside Therapeutics Site #14
    Orange City, Florida 32763, United States
  • Seaside Therapeutics Site #20
    Decatur, Georgia 30033, United States
  • Seaside Therapeutics Site #02
    Chicago, Illinois 60612, United States
  • Seaside Therapeutics Site #23
    Kansas City, Kansas 66160, United States
  • Seaside Therapeutics Site #12
    Baltimore, Maryland 21205, United States
  • Seaside Therapeutics Site #08
    Worcester, Massachusetts 01605, United States
  • Seaside Therapeutics Site #03
    Columbia, Missouri 65211, United States
  • Seaside Therapeutics Site #22
    New York, New York 10029, United States
  • Seaside Therapeutics Site #04
    Staten Island, New York 10314, United States
  • Seaside Therapeutics Site #24
    Chapel Hill, North Carolina 27514, United States
  • Seaside Therapeutics Site #21
    Durham, North Carolina 27710, United States
  • Seaside Therapeutics Site #05
    Akron, Ohio 44308, United States
  • Seaside Therapeutics Site #15
    Oklahoma City, Oklahoma 73117, United States
  • Seaside Therapeutics Site #11
    Media, Pennsylvania 19063, United States
  • Seaside Therapeutics Site #19
    Nashville, Tennessee 37212, United States
  • Seaside Therapeutics Site #25
    Houston, Texas 77090, United States
  • Seaside Therapeutics Site #18
    San Antonio, Texas 78258, United States
  • Seaside Therapeutics Site #13
    Seattle, Washington 98121, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01555333
Lead sponsor
Seaside Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 15, 2012
Start date
Nov 2011
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 31, 2013

Study contacts

Paul Wang, M.D.
study director · Seaside Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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