Comparison · NCT01511978-cb702e06
Continuous 3,4-Diaminopyridine (3,4-DAP) vs 3,4-DAP Taper to Placebo: Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline
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. Continuous 3,4-Diaminopyridine (3,4-DAP) vs 3,4-DAP Taper to Placebo: Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline. Trial comparisons, record NCT01511978-cb702e06. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01511978-cb702e06
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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 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk in group 2 | 0.722 | 0.491 | 0.875 | wilson | |
| Risk difference, group 1 minus group 2 | -0.722 | -0.875 | -0.406 | 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 Continuous 3,4-Diaminopyridine (3,4-DAP) than on 3,4-DAP Taper to Placebo | 1.38 | 1.14 | 2.46 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Continuous 3,4-Diaminopyridine (3,4-DAP) | Subjects were continued on their usual pre-randomization 3,4-DAP dosing regimen. | 0 | 14 | OG000 |
| Group 2 | 3,4-DAP Taper to Placebo | Subjects were tapered off of their pre-randomization 3,4-DAP dosing regimen over 3 days with up to an additional 16 hours of placebo. | 13 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline
- Description
The 3TUG time obtained 2 hours after the last dose of the withdrawal period (i.e., at time of theoretical peak drug effect) was compared to the average time-matched 3TUG tests performed during 2 days of baseline observation prior to randomization.~The study endpoint was a change of more than 30% in the final post-dose 3TUG during the withdrawal period and was based on blinded readings of video recordings of 3TUG tests.
- Time frame
Baseline period (days 0, 1, 2); Randomized treatment period (starting with last dose of day 2, and days 3, 4, 5, and ending with first dose on day 6 when pre-randomization regimen was resumed, or rescue, if indicated sooner)
- Population
Source ClinicalTrials.gov
Trial
- Title
- Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome
- NCT number
- NCT01511978
- Phases
- PHASE2
- Conditions
- Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome
- Interventions
- Continuous 3,4-DAP, Taper 3,4-DAP to Placebo
- Lead sponsor
- Jacobus Pharmaceutical
- Results first posted
- 2017-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01511978?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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