Comparison · NCT03772314-e322bf16
Modafinil vs Amphetamine-dextroamphetamine: Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Modafinil vs Amphetamine-dextroamphetamine: Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score. Trial comparisons, record NCT03772314-e322bf16. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03772314-e322bf16
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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 | 0.864 | 0.667 | 0.953 | wilson | |
| Risk in group 2 | 0.8 | 0.584 | 0.919 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0636 | -0.167 | 0.297 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.82 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.308 | 8.15 | log | |
| Number needed to treat, for one more participant with the outcome on Modafinil than on Amphetamine-dextroamphetamine | 15.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Modafinil | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take modafinil. Participants received 100-400 mg/day of modafinil for 12 weeks. | 19 | 22 | OG000 |
| Group 2 | Amphetamine-dextroamphetamine | Participants with narcolepsy type 2 or idiopathic hypersomnia randomized to take amphetamine-dextroamphetamine (amphetamine salts). Participants received 10-40 mg/day of oral amphetamine salts for 12 weeks. | 16 | 20 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
- Description
The PGIC for Sleepiness asks respondents to rate their sleepiness compared to baseline. Responses are indicated on a 7-point scale where 1 = very much improved, 2 = much improved, 3 = minimally improved 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. Responses were dichotomized into groups of participants who were treatment responders having any level of improvement (responses of minimally improved, much improved, or very much improved) and treatment non-responders (responses of no change to very much worse). The number of participants reporting any improvement at the Week 12 assessment compared to how they felt right before starting the study medication was examined.
- Time frame
- Week 12
- Population
This analysis includes the modified intent to treat study population consisting of all participants who were randomized and took at least one dose of study medication. The last observation is used for participants who did not complete the study or had missing responses. Two participants in the amphetamine-dextroamphetamine group withdrew prior to completing any PGIC scales and are not included in this analysis.
Source ClinicalTrials.gov
Trial
- Title
- Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
- NCT number
- NCT03772314
- Phases
- PHASE2
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
- Interventions
- Modafinil, Amphetamine-Dextroamphetamine
- Lead sponsor
- Emory University
- Results first posted
- 2024-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03772314?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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