Trial · NCT01511978

Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome

NCT01511978, Phase 2, Completed, Jacobus Pharmaceutical; results first posted 2017-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome. Trials, record NCT01511978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01511978

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome
NCT number: NCT01511978
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: Jacobus Pharmaceutical
Conditions: Lambert-Eaton Myasthenic Syndrome, Eaton-Lambert Myasthenic Syndrome
Interventions: Continuous 3,4-DAP, Taper 3,4-DAP to Placebo
First posted: 2012-01-19
Last updated: 2017-07-11
Results first posted: 2017-07-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline	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)	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.
Secondary	Self-assessment of LEMS-related Weakness, W-SAS	Participants were followed for up to 7 days	The last post-dose self-assessment of LEMS-related weakness from the withdrawal period with categories of much much weaker (-3), much weaker (-2), somewhat weaker (-1), about the same (0), somewhat stronger (1), much stronger (2), and much much stronger (3).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline	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)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Self-assessment of LEMS-related Weakness, W-SAS	Participants were followed for up to 7 days		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline	Continuous 3,4-Diaminopyridine (3,4-DAP)	0		Participants
Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline	3,4-DAP Taper to Placebo	13		Participants
Self-assessment of LEMS-related Weakness, W-SAS	3,4-DAP	-0.2	Standard Deviation 1.24	units on a scale
Self-assessment of LEMS-related Weakness, W-SAS	3,4-DAP Taper to Placebo	-2.4	Standard Deviation 0.85	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Continuous 3,4-DAP	14
Overall Study	STARTED	Taper 3,4-DAP to Placebo	18
Overall Study	COMPLETED	Continuous 3,4-DAP	14
Overall Study	COMPLETED	Taper 3,4-DAP to Placebo	18
Overall Study	NOT COMPLETED	Continuous 3,4-DAP	0
Overall Study	NOT COMPLETED	Taper 3,4-DAP to Placebo	0

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal discomfort	Gastrointestinal disorders	Continuous 3,4-Diaminopyridine (3,4-DAP)	0	14
other	Abdominal discomfort	Gastrointestinal disorders	3,4-DAP Taper to Placebo	2	18
other	Respiratory tract infection	Infections and infestations	Continuous 3,4-Diaminopyridine (3,4-DAP)	0	14
other	Respiratory tract infection	Infections and infestations	3,4-DAP Taper to Placebo	2	18
other	Back pain	Musculoskeletal and connective tissue disorders	Continuous 3,4-Diaminopyridine (3,4-DAP)	1	14
other	Back pain	Musculoskeletal and connective tissue disorders	3,4-DAP Taper to Placebo	1	18
other	Headache	Nervous system disorders	Continuous 3,4-Diaminopyridine (3,4-DAP)	1	14
other	Headache	Nervous system disorders	3,4-DAP Taper to Placebo	1	18
other	Nasopharyngitis	Infections and infestations	Continuous 3,4-Diaminopyridine (3,4-DAP)	1	14
other	Nasopharyngitis	Infections and infestations	3,4-DAP Taper to Placebo	1	18

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Continuous 3,4-Diaminopyridine (3,4-DAP)	0	14
Total, all-cause mortality	3,4-DAP Taper to Placebo	0	18
Total, other adverse events	Continuous 3,4-Diaminopyridine (3,4-DAP)	5	14
Total, other adverse events	3,4-DAP Taper to Placebo	12	18
Total, serious adverse events	Continuous 3,4-Diaminopyridine (3,4-DAP)	0	14
Total, serious adverse events	3,4-DAP Taper to Placebo	1	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
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
Continuous 3,4-Diaminopyridine (3,4-DAP) vs 3,4-DAP Taper to Placebo: deaths from any cause	Trial comparisons
Continuous 3,4-Diaminopyridine (3,4-DAP) vs 3,4-DAP Taper to Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01511978

GET https://conductscience.org/api/trials/v1/NCT01511978/events?page=2

API reference For AI assistants