Trial · NCT01377922

A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

NCT01377922, Phase 3, Completed, Catalyst Pharmaceuticals, Inc.; results first posted 2018-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS). Trials, record NCT01377922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01377922

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Trial

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

Title: A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)
NCT number: NCT01377922
Status: Completed
Phases: Phase 3
Enrollment: 38 participants, actual
Lead sponsor: Catalyst Pharmaceuticals, Inc.
Conditions: Lambert Eaton Myasthenic Syndrome
Interventions: Amifampridine Phosphate, Placebo
First posted: 2011-06-22
Last updated: 2018-01-04
Results first posted: 2018-01-04

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Assessment at Baseline and Day 14	The QMG is a physician-rated test including 13 assessments, including facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each of the 13 items is scored from 0 (none) to 3 (severe). The total score can range from 0 to 39. Increased QMG total score correlates to worsening symptoms of LEMS.
Primary	Change in SGI Score	Assessment at Baseline and Day 14	Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing. The patient is asked to use the 7-point scale below to rate their impression of the effects of the study medication during the preceding 3 days on their physical well being. 1. Terrible 2. Mostly dissatisfied 3. Mixed 4. Partially satisfied 5. Mostly satisfied 6. Pleased 7. Delighted
Secondary	Change From Baseline Timed 25 Foot Walking Test (T25FW) at 14 Days	Assessment at Baseline and Day 14	The T25FW test, a component of the Multiple Sclerosis Functional Composite, was a quantitative mobility and leg function performance test based on a timed 25-foot walk (National Multiple Sclerosis Society). The patient was directed to walk a clearly marked 25-foot course as quickly and safely as possible. Following a rest of at least 5 minutes, the timed 25-foot walk was repeated. Patients could use assistive devices, such as canes, crutches, or walkers. All data were normalized to the number of feet per minute, so if the patient walked 25 feet in less than a minute, the result was a speed greater than 25 feet/minute. The measurement for the T25FW test was the average speed, expressed in feet/minute, of the 2 completed walks.
Secondary	Change in CGI-I Score	Baseline and Day 14	The Investigator completed the 7-point CGI I, based on changes in symptoms, behavior, and functional abilities, at the protocol-specified time points compared to the patient's condition at Day 0. 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Assessment at Baseline and Day 14		QMG Score	MEAN
PRIMARY	Change in SGI Score	Assessment at Baseline and Day 14	FAS	SGI score	MEAN
SECONDARY	Change From Baseline Timed 25 Foot Walking Test (T25FW) at 14 Days	Assessment at Baseline and Day 14		feet/minute	MEAN
SECONDARY	Change in CGI-I Score	Baseline and Day 14		CGI-I score	MEAN

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Placebo	Baseline	5.6	Standard Deviation 3.99	QMG Score
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Amifampridine Phosphate	Baseline	6.4	Standard Deviation 3.22	QMG Score
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Placebo	Day 14	7.9	Standard Deviation 2.85	QMG Score
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Amifampridine Phosphate	Day 14	6.7	Standard Deviation 4.09	QMG Score
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Placebo	Change from Baseline	2.2	Standard Deviation 2.93	QMG Score
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days	Amifampridine Phosphate	Change from Baseline	0.3	Standard Deviation 2.60	QMG Score
Change in SGI Score	Placebo	Baseline	5.9	Standard Deviation 1.22	SGI score
Change in SGI Score	Amifampridine Phosphate	Baseline	5.6	Standard Deviation 1.26	SGI score
Change in SGI Score	Placebo	Day 14	3.2	Standard Deviation 1.7	SGI score
Change in SGI Score	Amifampridine Phosphate	Day 14	4.9	Standard Deviation 1.57	SGI score

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Part 2 and Part 3 Placebo	22
Overall Study	STARTED	Part 2 and Part 3 Amifampridine Phosphate	16
Overall Study	COMPLETED	Part 2 and Part 3 Placebo	21
Overall Study	COMPLETED	Part 2 and Part 3 Amifampridine Phosphate	16
Overall Study	NOT COMPLETED	Part 2 and Part 3 Placebo	1
Overall Study	NOT COMPLETED	Part 2 and Part 3 Amifampridine Phosphate	0

Source ClinicalTrials.gov

Adverse events24

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	Nasopharyngitis	Infections and infestations	Part 2 and Part 3 Placebo	0	21
other	Nasopharyngitis	Infections and infestations	Part 2 and Part 3 Amifampridine Phosphate	1	16
other	Otitis externa	Infections and infestations	Part 2 and Part 3 Placebo	0	21
other	Otitis externa	Infections and infestations	Part 2 and Part 3 Amifampridine Phosphate	1	16
other	Periodontitis	Infections and infestations	Part 2 and Part 3 Placebo	1	21
other	Periodontitis	Infections and infestations	Part 2 and Part 3 Amifampridine Phosphate	0	16
other	Pulpitis dental	Infections and infestations	Part 2 and Part 3 Placebo	1	21
other	Pulpitis dental	Infections and infestations	Part 2 and Part 3 Amifampridine Phosphate	0	16
other	Urinary tract infection	Infections and infestations	Part 2 and Part 3 Placebo	0	21
other	Urinary tract infection	Infections and infestations	Part 2 and Part 3 Amifampridine Phosphate	1	16

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 2 and Part 3 Placebo	0	22
Total, all-cause mortality	Part 2 and Part 3 Amifampridine Phosphate	0	16
Total, other adverse events	Part 2 and Part 3 Placebo	6	21
Total, other adverse events	Part 2 and Part 3 Amifampridine Phosphate	3	16
Total, serious adverse events	Part 2 and Part 3 Placebo	0	22
Total, serious adverse events	Part 2 and Part 3 Amifampridine Phosphate	0	16

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 comparisons2

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

Comparison	Source
Part 2 and Part 3 Placebo vs Part 2 and Part 3 Amifampridine Phosphate: deaths from any cause	Trial comparisons
Part 2 and Part 3 Placebo vs Part 2 and Part 3 Amifampridine Phosphate: 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.

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GET https://conductscience.org/api/trials/v1/NCT01377922/results?page=2

API reference For AI assistants