Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT05418049
The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.
This study is active but is not currently recruiting participants.
18 year–45 year
All sexes
Interventional
Phase 2
Cincinnati, Ohio, 45229, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30mg - Supplied as 10mg and 20mg tablets
two 10 mg tablets
Other names: NAMENDA
250 mcg capsule
Other names: DAILIRESP
Placebo pill
Time frame: Pre-dose, 3-hour post-dose
EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose.
Time frame: Pre-dose, 3-hour post-dose
The Clinical Global Impressions - Improvement (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).
Time frame: Pre-dose, 3-hour post-dose
The CGI-I requires the caregiver to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse).
Time frame: Pre-dose, 3-hour post-dose
The parent or caregiver will be asked to assess how much anxiety the participant is expressing on a line between two endpoints (no anxiety to worsened anxiety).
Time frame: Pre-dose, 3-hour post-dose
An examinee will be prompted to complete four different reversal learning tasks on a computer, each which had two phases: Acquisition and Reversal. Participants will be instructed to choose one of two identical stimuli positioned in different locations on the screen. Participant behavior will be reinforced on 80% of correct responses and on 20% of incorrect responses. During the acquisition phase, participants chose one of two stimulus locations until they identified the correct location on 8 of 10 consecutive trials. Then, they proceeded to the reversal phase in which the correct location is switched without warning, and participants had to identify the new correct location on 8 of 10 consecutive trials. Testing was discontinued if they did not reach criterion within 50 trials on either phase. Participants completed two practice tests to establish test comprehension. We computed total number of trials to reach criterion and number of errors after reversal.
Time frame: 3-hour post-dose
Computerized tasks comprised of 3 subtests where an examinee is shown a series of target stimuli, oral reading components, directional decision-making and picture vocabulary.
Time frame: 3 hour post-dose
An examinee will provide a sample of their spoken language while they create a narrative of a story. Participants were asked to tell the story of a wordless picture book "Frog Goes to Dinner." First the examiner showed the participant each page of the book at a 10 s interval per page. The examiner then asked the participant to tell the story page by page. The examiner utilized scripted prompts to encourage the participants to narrate the book with his/her own words. Digital audio-recorded samples were then de-identified and transferred to the at the UC Davis MIND Institute for transcription and analysis. The samples were transcribed using Systematic Analysis of Language Transcripts, 2018 Research Version software (SALT). The SALT program performs predetermined and customized analysis of text language files.
Time frame: Pre-dose, 3-hour post-dose
Computerized task where an examinee is required to push a key when a target stimulus is presented on the screen. Scores are presented as change in median reaction time (RT), in milliseconds.
Time frame: Pre-dose, 3-hour post-dose
An examinee will observe a series of pictures and videos on a computer screen where a video will capture gaze preference.
Children's Hospital Medical Center, Cincinnati
Other
Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Baclofen, Roflumilast, Memantine, and Placebo in Fragile X Syndrome
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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