Fragile X SyndromePhase 2NCT00054730
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
A Phase 2 study testing CX516 (Ampalex®) in people with Fragile X Syndrome and Autism, run by RespireRx at 2 sites in United States.
Trial summary
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism. CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fragile X Syndrome, Autism
- What is being tested?
- CX516 (Ampalex®)
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to not given
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fragile X group
- DNA-based diagnosis of Fragile X syndrome
- Autism group
- Documented diagnosis with ADOS; ADI-R; CARS and GARS
- Both groups
- 18-50 years
Show all 13Show fewer
- Measured IQ below 85
- Measured IQ >20
- Mental age >30 months
- Stable medication regimen for past 8 weeks
- Normal hearing
- Vision corrected to at least 20/50
- All females of childbearing age must have a negative pregnancy test at enrollment
Who cannot join
- Recent history of seizure, epilepsy, or blackouts
- Unresolved medical issue impacting performance
- Behavioral dysfunction to the point that subject cannot cooperate for testing
- History of drug-induced neutropenia
- Uncontrolled hypertension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RUSH-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
UC Davis-MIND Institute
Sacramento, California, 95817
About this study
Official title: Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism.
CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning.
Read more
There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder.
Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.
- Conditions
- Fragile X Syndrome, Autism
- Being tested
- CX516 (Ampalex®)
- Keywords
- Fragile X Syndrome, Autism
- Medical subject headings
- Fragile X Syndrome, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX516 (Ampalex®)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2003 (estimated)
- Study startJun 2002
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
- Double blind
Sponsor and investigators
- Lead sponsor
- RespireRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FRAXA Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054730
- Sponsor's protocol ID
- CORX-CX516-013
- Status last verified
- Feb 2005
- First submitted
- 7 Feb 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism
- ClinicalTrials.gov ID
- NCT00054730
- Acronym / sponsor ID
- CORX-CX516-013
- Conditions
- Fragile X Syndrome, Autism
- Keywords
- Fragile X Syndrome, Autism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- RespireRxIndustry (pharma, biotech, devices)
- Collaborators
- FRAXA Research Foundation
- Study start
- Jun 2002
- First posted
- 11 Feb 2003 (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.
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism.
CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning.
There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder.
Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Fragile X group
- DNA-based diagnosis of Fragile X syndrome
- Autism group
- Documented diagnosis with ADOS; ADI-R; CARS and GARS
- Both groups
Key exclusion criteria (5 listed)
- Recent history of seizure, epilepsy, or blackouts
- Unresolved medical issue impacting performance
- Behavioral dysfunction to the point that subject cannot cooperate for testing
- History of drug-induced neutropenia
- Uncontrolled hypertension
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 |
|---|---|---|
| CX516 (Ampalex®) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Fraxa is a research foundation whose mission is to support research aimed at treatment for Fragile X syndrome.Link provided by the sponsor.
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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.
2 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 CX516 (Ampalex®) in people with Fragile X Syndrome and Autism, run by RespireRx at 2 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Jun 2005.