Comparison · NCT00850070-69650b95
Sapropterin vs Placebo: Clinical Global Impression -- Severity (CGI-S) Scale
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Sapropterin vs Placebo: Clinical Global Impression -- Severity (CGI-S) Scale. Trial comparisons, record NCT00850070-69650b95. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00850070-69650b95
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.13 | 0.0454 | 0.321 | wilson | |
| Risk in group 2 | 0.0435 | 0.00772 | 0.21 | wilson | |
| Risk difference, group 1 minus group 2 | 0.087 | -0.1 | 0.281 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.336 | 26.8 | log | |
| Odds ratio, group 1 over group 2 | 3.3 | 0.317 | 34.4 | log | |
| Number needed to treat, for one more participant with the outcome on Sapropterin than on Placebo | 11.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sapropterin | sapropterin 20 mg/kg/day | 3 | 23 | OG000 |
| Group 2 | Placebo | sugar pill | 1 | 23 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Clinical Global Impression -- Severity (CGI-S) Scale
- Description
The CGI-S assessed the number of participants with improved severity illness on the CGI-S scale. This is a summary judgment made by a trained clinician of symptom severity. It is a 7-point scale that rates the severity of the patient's illness at time of assessment with 1 - normal, not at all, to 7 - extremely ill. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time
- Time frame
- Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.
- Population
This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at number of children who improved (from markedly, severely or extremely ill to markedly, mildly or no illness) at 16-week time frame.
Source ClinicalTrials.gov
Trial
- Title
- Sapropterin as a Treatment for Autistic Disorder
- NCT number
- NCT00850070
- Phases
- PHASE2
- Conditions
- Autistic Disorder
- Interventions
- sapropterin, Placebo
- Lead sponsor
- The Children's Health Council
- Results first posted
- 2014-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00850070?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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