Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome (LAM)
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|ClinicalTrials.gov Identifier: NCT02998151|
Recruitment Status : Enrolling by invitation
First Posted : December 20, 2016
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: Acamprosate Drug: Lovastatin Drug: Minocycline Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
Placebo Comparator: Placebo
two 666 pills
two 20mg pills
two 135mg pills
- Change in EEG from baseline [ Time Frame: Pre-dose, 4-hour post-dose ]EEG will be used to assess the electrophysiologic aspects of auditory processing
- Clinical Global Impressions Improvement [ Time Frame: 4-hour post-dose ]The CGI-I requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse).
- Clinical Global Impressions Severity [ Time Frame: Pre-dose ]. The CGI-S is a 7-point scale designed to measure global severity of illness over the previous seven days.
- Aberrant Behavior Checklist [ Time Frame: Baseline and beginning of each visit to assess previous 2 weeks ]The recently validated Aberrant Behavior Checklist (ABC) using the 6-factor FXS model will be used as a secondary outcome of clinical status.
- Woodcock Johnson Test of cognitive abilities - auditory attention task [ Time Frame: Baseline visit, 4-hour post-dose ]Identify parts needed to form a complete shape and Identify orally presented words amid increasingly intense background noise
- Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: Pre-dose, 4-hour post dose ]A 10-item list of unrelated words is presented orally to the examinee who is then required to immediately recall words presented.
- Test of Attentional Performance for Children (KiTAP) [ Time Frame: Predose, 4-hour post-dose ]Computerized task comprised of 8 subtests where an examinee is required to push a key when a target stimulus is presented on the screen.
- Grooved Pegboard Test [ Time Frame: Baseline visit, 4-hour post-dose ]Pegs, with a key along one side, must be rotated to match the holes in the pegboard before they can be inserted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998151
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Craig A Erickson, M.D.||Children's Hospital Medical Center, Cincinnati|