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GABA-B Agonist
Single Dose Drug Challenge for Fragile X Syndrome
Phase 2
Recruiting
Led By Craig A. Erickson, M.D.
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects ages 18-45, with FXS who completed the study entitled "Mechanisms and brain circuits underlying fragile X syndrome" (IRB # 2015-8425) or appropriate baseline measures through Biorepository (2013-7327)
FXS is defined as full FMR1 mutations (>200 CGG repeats) confirmed by genetic testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hour post-dose
Awards & highlights
Study Summary
This trial is testing a possible medication for Fragile X Syndrome by seeing how it affects brain function, behavior, and clinical measures.
Who is the study for?
This trial is for adults aged 18-45 with Fragile X Syndrome, confirmed by genetic testing, who are generally healthy and have a Stanford Binet IQ under 85. Participants must not be pregnant or breastfeeding, should have been on stable psychotropic drugs for at least four weeks, and cannot have certain medical conditions or history of drug intolerance.Check my eligibility
What is being tested?
The study tests the effects of Baclofen, Memantine, Roflumilast versus a placebo in improving neurophysiologic functions and clinical symptoms associated with Fragile X Syndrome. It measures changes from before to after dosing using various assessments.See study design
What are the potential side effects?
Possible side effects include those commonly associated with Baclofen (muscle weakness, dizziness), Memantine (confusion, headache), and Roflumilast (nausea, weight loss). The exact side effects will vary depending on which medication participants receive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am aged 18-45 with fragile X syndrome and participated in a specific study or provided baseline measures.
Select...
My genetic test shows I have Fragile X syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-hour post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-hour post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in EEG Relative Gamma Power
Secondary outcome measures
Clinical Global Impressions-Improvement
Clinical Global Impressions-Improvement-Caregiver
Visual Analog Scale - Caregiver
Other outcome measures
Expressive Language Sampling (ELS)
Eye-tracking
NIH Cognitive Toolbox
+2 moreSide effects data
From 2015 Phase 4 trial • 12 Patients • NCT030737988%
Pulmonary Exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants
Trial Design
1Treatment groups
Experimental Treatment
Group I: All Study ParticipantsExperimental Treatment4 Interventions
Participants received, in random order, a single dose of placebo, baclofen, roflumilast or memantine with a two-week washout period between doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baclofen
FDA approved
Memantine
FDA approved
Roflumilast
FDA approved
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,546 Total Patients Enrolled
6 Trials studying Fragile X Syndrome
450 Patients Enrolled for Fragile X Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,752 Total Patients Enrolled
7 Trials studying Fragile X Syndrome
35,436 Patients Enrolled for Fragile X Syndrome
Craig A. Erickson, M.D.Principal InvestigatorChildren's Hospital Medical Center, Cincinnati
3 Previous Clinical Trials
295 Total Patients Enrolled
1 Trials studying Fragile X Syndrome
14 Patients Enrolled for Fragile X Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am aged 18-45 with fragile X syndrome and participated in a specific study or provided baseline measures.Your IQ score is less than 85 on the Stanford Binet test.You can't participate if you have taken a new or experimental drug in the past 3 months, have a history of substance abuse in the past 6 months, or have a serious mental or brain-related illness not related to FXS.You have hearing or vision problems that can't be fixed according to specific tests.I am currently taking medications like painkillers, sedatives, or specific antibiotics and antifungals.I have been on the same dose of my psychiatric medication for at least 4 weeks.I have had a seizure or uncontrolled epilepsy in the last 6 months.I am currently taking medications for seizures or anxiety.I have moderate to severe kidney or liver problems, confirmed by a doctor.My kidney function, measured by creatinine clearance, is 50 mL/min or higher.My genetic test shows I have Fragile X syndrome.You have had a bad reaction to baclofen, roflumilast, or memantine in the past.My mental health medication doses have been stable for over a month.
Research Study Groups:
This trial has the following groups:- Group 1: All Study Participants
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this clinical trial that are open to participants?
"Unfortunately, per the clinicaltrials.gov information, this trial is not currently open to new participants. After being posted on September 1st 2022 and updated last on August 15th 2022, it has closed recruitment for now; however there remain 1388 other trials actively searching for patients at present."
Answered by AI
Are participants under the age of fifty eligible for this clinical trial?
"This trial is only for individuals between 18 and 45 years of age. People younger than this will find 376 other trials to participate in, while those over 65 can look across 985 alternative studies."
Answered by AI
What type of individuals are eligible for inclusion in this clinical research?
"This research endeavour is looking for 45 people aged between 18 and 45 suffering from fraxa syndrome. To be eligible, candidates must have completed the medical study "Mechanisms and Brain Circuits Underlying Fragile X Syndrome" (IRB # 2015-8425) or possess baseline measures through Biorepository (2013-7327), with a full FMR1 mutation of over 200 CGG repeats confirmed by genetic testing, good physical health as determined via examination, lab work up, score below 85 on the Stanford Binet IQ test, and remain stable while taking psychotropic drugs for at least 4 weeks."
Answered by AI
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