Fragile X SyndromePhase 2NCT01325740
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
A Phase 2 study testing STX107 in people with Fragile X Syndrome, run by Seaside Therapeutics, Inc. at 5 sites in United States.
Trial summary
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Fragile X Syndrome
- What is being tested?
- STX107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2011to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects 18 to 50 years of age, inclusive.
- Molecular documentation of the full fragile X mutation.
Who cannot join
- Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
- Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
- Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- Subjects who, in the Investigator's opinion, might not be suitable for the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Denver, Children's Hospital
Aurora, Colorado, 80045
Rush University Medical Center
Chicago, Illinois, 60612
Emory University School of Medicine
Decatur, Georgia, 30033
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024
University of California-Davis, M.I.N.D. Institute
Sacramento, California, 95817
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
- Conditions
- Fragile X Syndrome
- Being tested
- STX107
- Medical subject headings
- Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STX107Drug
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
| Study group | Role | What they receive |
|---|---|---|
| STX107 10 mg | Active comparator | Not described Receives: Drug: STX107 |
| Placebo | Placebo comparator | Not described Receives: Drug: STX107 |
| STX107 30 mg | Active comparator | Not described Receives: Drug: STX107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events will be monitored for tolerability
physical exam, laboratories, collection of adverse events
Measured: 1 day
Secondary outcomes (1)
Blood levels of STX107 will be measured to define pharmacokinetics
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: pending further evaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragile X SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seaside Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325740
- Sponsor's protocol ID
- 107FX201
- Status last verified
- Dec 2012
- First submitted
- 28 Mar 2011
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT01325740
- Acronym / sponsor ID
- 107FX201
- Conditions
- Fragile X Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: pending further evaluation
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Seaside Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STX107 10 mg | Active comparator | Drug: STX107 |
| Placebo | Placebo comparator | Drug: STX107 |
| STX107 30 mg | Active comparator | Drug: STX107 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male subjects 18 to 50 years of age, inclusive.
- Molecular documentation of the full fragile X mutation.
Key exclusion criteria (4 listed)
- Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
- Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
- Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- Subjects who, in the Investigator's opinion, might not be suitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STX107STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule | Drug | Placebo, STX107 10 mg, STX107 30 mg |
Primary outcome
Adverse events will be monitored for tolerability
Time frame: 1 day
physical exam, laboratories, collection of adverse events
1 secondary outcome
Blood levels of STX107 will be measured to define pharmacokinetics
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STX107 in people with Fragile X Syndrome, run by Seaside Therapeutics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events will be monitored for tolerability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.