Comparison · NCT03283371-e6fae1d5
Natalizumab 300 mg (Placebo-controlled Phase) vs Placebo (Placebo-controlled Phase): Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment
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. Natalizumab 300 mg (Placebo-controlled Phase) vs Placebo (Placebo-controlled Phase): Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment. Trial comparisons, record NCT03283371-e6fae1d5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03283371-e6fae1d5
On this page
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 | 0 | 0.11 | wilson | |
| Risk in group 2 | 0.0294 | 0.00521 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0294 | -0.149 | 0.0835 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Natalizumab 300 mg (Placebo-controlled Phase) than on Placebo (Placebo-controlled Phase) | 34 | 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 | Natalizumab 300 mg (Placebo-controlled Phase) | Participants received natalizumab 300 mg IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. | 0 | 31 | OG001 |
| Group 2 | Placebo (Placebo-controlled Phase) | Participants received natalizumab-matching placebo IV infusion every 4 weeks in Placebo-controlled Phase for up to Week 24. | 1 | 34 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Free From Seizures During Weeks 8 to 24 of Treatment
- Description
Seizure free is defined as a participant with no seizure reported and no missing diary during Weeks 8 to 24. Participants who withdrew from treatment, required modifications of AEDs prior to Week 24 (completion of the Placebo-controlled Phase), or any missing diary data during Weeks 8 to 24 of treatment were not considered as seizure free in the analysis.
- Time frame
- Week 8 to Week 24
- Population
The ITT population is defined as all participants who were randomized and received any dose of study treatment. Here, number of participants analyzed signifies number of participants who were analyzed in this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
- NCT number
- NCT03283371
- Phases
- PHASE2
- Conditions
- Epilepsy, Focal Seizures, Partial Seizures
- Interventions
- Natalizumab, Placebo
- Lead sponsor
- Biogen
- Results first posted
- 2021-04-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03283371?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03283371-e6fae1d5