Trial · NCT03275012
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 33 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Vd/F | at week 3 or at week 4 or at week 16 | Primary pharmacokinetic parameter for gabapentin: assessment of apparent volume of distribution (Vd/F) and of its variability and precision. In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | ka | at week 3 or at week 4 or at week 16 | Primary pharmacokinetic parameter for gabapentin: assessment of absorption rate constant (Ka) and of its precision and variability. In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | AUC | at week 3 or at week 4 or at week 16 | Secondary pharmacokinetic parameter for gabapentin: assessment of Area under the Concentration curve (AUC). In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | Cmax | at week 3 or at week 4 or at week 16 | Secondary pharmacokinetic parameter for gabapentin: assessment of peak plasma concentration (Cmax). In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | Tmax | at week 3 or at week 4 or at week 16 | Secondary pharmacokinetic parameter for gabapentin: assessment of time at which the Cmax is observed (Tmax). In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | Css | at week 3 or at week 4 or at week 16 | Secondary pharmacokinetic parameter for gabapentin: assessment of steady state Concentrations (Css). In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | Cmin | at week 3 or at week 4 or at week 16 | Secondary pharmacokinetic parameter for gabapentin: assessment of minimum concentration (Cmin). In total, 4 samples will be collected, 1 before dosing and again at 3 different time windows post-dosing (0 - 2 h; 2 - 4 h and 4 - 6 h) |
| Secondary | Systemic exposure to investigational product | an average of 12 weeks | Systemic exposure to investigational product during maintenance period, as assessed by predicted steady-state concentrations. |
| Secondary | Incidence of Adverse Events | up to 21 weeks | Incidence of Adverse Events at all visits |
| Secondary | Percentage of subjects discontinuing the Trial | up to 21 weeks | Percentage of subjects discontinuing the Trial due to treatment-emergent adverse events |
| Secondary | Aggressive behaviour in children aged >6 years | an average of 15 weeks | Aggressive behaviour in children aged \>6 years using the Retrospective Modified Overt Aggression Scale (R-MOAS) at V2, V6 and EOS visit (V10). The scale includes 4 domains (Verbal Incidents, Incidents Toward Other People, Incidents Involving Property, Incidents Directed Toward Self) each one describing different behaviours. Parents rate the frequency of 16 aggressive behaviors (referred to the past week) in the 4 areas. Numeric weighting amplifies the seriousness of more harmful behaviors in the total score. Higher score indicating more aggressive behavior. |
| Secondary | Suicidal ideation/behaviour in subjects aged 6 years and older | an average of 16 weeks | Suicidal ideation/behaviour in subjects aged 6 years and older using the Columbia - Suicide Severity Rating Scale (C-SSRS) scores before IMP (screening V1), V6, EOS visit (V10) and taper visit (V11). The C-SSRS is divided into 2 sections: Suicidal Ideation and Suicidal Behaviour containing each one 5 "yes" or "no" questions. Suicidal Ideation Score: The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. A score of 0 is assigned if no ideation is present. Composite endpoints are defined below: Suicidal ideation: A "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5). Suicidal behavior: A "yes" answer at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10). Suicidal ideation or behavior: A "yes" answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (Categories 1-10) |
| Secondary | Assessment of blinding | at week 16 | Assessment of blinding: guess of the subject's treatment group (by Investigator, parents and subject if at adequate maturity level) at V10. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03275012/registered?page=2