Trial · NCT02970162
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
NCT02970162, Phase 3, Completed, Catalyst Pharmaceuticals, Inc.; results first posted 2018-12-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS). Trials, record NCT02970162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02970162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
- NCT number
- NCT02970162
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Conditions
- Lambert-Eaton Myasthenic Syndrome
- Interventions
- Amifampridine Phosphate, Placebo Oral Tablet
- First posted
- 2016-11-21
- Last updated
- 2018-12-24
- Results first posted
- 2018-12-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quantitative Myasthenia Gravis (QMG) Score | change from baseline in QMG score at end of day 4 | The QMG is a physician-rated test including 13 assessments such as facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each assessment is graded as 0 (none), 1 (mild), 2 (moderate), or 3 (severe), for a total range of 0-39. A higher total score indicates a worse outcome. |
| Primary | Subject Global Impression (SGI) Score | change from baseline in SGI score at end of day 4 | The SGI is a 7-point scale on which the patient rates their global impression of the effects of a study treatment (1=terrible to 7=delighted). The SGI was assessed by the patient or the patient's parent/guardian/caregiver if the patient was unable to complete the SGI. The SGI has demonstrated concordance with the physician's assessment of improvement. |
| Secondary | Change in Clinician's Global Impression of Improvement (CGI-I) at Day 4 Compared to Baseline | change from baseline in CGI-I score at end of day 4 | The CGI-I captures the Investigator's global impression of the patient's improvement or worsening from baseline status. The 7-point scale is scored by the Investigator based on changes in symptoms, behavior, and functional abilities. Each symptom is rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse). The total score can range from 0 to 49. A higher score indicates a worse outcome. |
| Other | Triple Timed Up and Go Walk Test (3TUG) | change from baseline in 3TUG at end of day 4 | The 3TUG is a functional mobility test that requires a patient to stand up from a straight-backed armchair, walk 3 meters, turn around, walk back, and sit down in the chair. A modification of this is where the individual performs the test 3 times without pause, and the measurement is the average time required to complete each of the 3 repetitions. Based upon literature reports that a significant change in gait for a similar walk-test is an increase in time of more than 20%, this has been incorporated into the endpoint. |
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 | Quantitative Myasthenia Gravis (QMG) Score | change from baseline in QMG score at end of day 4 | scores on a scale | MEAN | |
| PRIMARY | Subject Global Impression (SGI) Score | change from baseline in SGI score at end of day 4 | scores on a scale | MEAN | |
| SECONDARY | Change in Clinician's Global Impression of Improvement (CGI-I) at Day 4 Compared to Baseline | change from baseline in CGI-I score at end of day 4 | scores on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Triple Timed Up and Go Walk Test (3TUG) | change from baseline in 3TUG at end of day 4 | The number and proportion of patients with a ≥20% increase in 3TUG average time | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quantitative Myasthenia Gravis (QMG) Score | Amifampridine Phosphate | Baseline | 7.8 | Standard Deviation 4.20 | scores on a scale |
| Quantitative Myasthenia Gravis (QMG) Score | Placebo (for Amifampridine Phosphate) | Baseline | 8.5 | Standard Deviation 5.43 | scores on a scale |
| Quantitative Myasthenia Gravis (QMG) Score | Amifampridine Phosphate | Day 4 | 7.9 | Standard Deviation 4.94 | scores on a scale |
| Quantitative Myasthenia Gravis (QMG) Score | Placebo (for Amifampridine Phosphate) | Day 4 | 15.0 | Standard Deviation 5.90 | scores on a scale |
| Quantitative Myasthenia Gravis (QMG) Score | Amifampridine Phosphate | Change from baseline | 0.1 | Standard Deviation 3.07 | scores on a scale |
| Quantitative Myasthenia Gravis (QMG) Score | Placebo (for Amifampridine Phosphate) | Change from baseline | 6.5 | Standard Deviation 4.82 | scores on a scale |
| Subject Global Impression (SGI) Score | Amifampridine Phosphate | Baseline | 6.1 | Standard Deviation 0.86 | scores on a scale |
| Subject Global Impression (SGI) Score | Placebo (for Amifampridine Phosphate) | Baseline | 5.8 | Standard Deviation 0.90 | scores on a scale |
| Subject Global Impression (SGI) Score | Amifampridine Phosphate | Day 4 | 5.3 | Standard Deviation 1.65 | scores on a scale |
| Subject Global Impression (SGI) Score | Placebo (for Amifampridine Phosphate) | Day 4 | 2.4 | Standard Deviation 1.76 | scores on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amifampridine Phosphate | 13 | |
| Overall Study | STARTED | Placebo (for Amifampridine Phosphate) | 13 | |
| Overall Study | COMPLETED | Amifampridine Phosphate | 13 | |
| Overall Study | COMPLETED | Placebo (for Amifampridine Phosphate) | 13 | |
| Overall Study | NOT COMPLETED | Amifampridine Phosphate | 0 | |
| Overall Study | NOT COMPLETED | Placebo (for Amifampridine Phosphate) | 0 |
Source ClinicalTrials.gov
Adverse events76
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 | Events |
|---|---|---|---|---|---|---|
| other | atrial fibrillation | Cardiac disorders | Amifampridine Phosphate | 0 | 13 | |
| other | atrial fibrillation | Cardiac disorders | Placebo (for Amifampridine Phosphate) | 1 | 13 | |
| other | myocardial ischemia | Cardiac disorders | Amifampridine Phosphate | 0 | 13 | |
| other | myocardial ischemia | Cardiac disorders | Placebo (for Amifampridine Phosphate) | 4 | 13 | |
| other | motion sickness | Ear and labyrinth disorders | Amifampridine Phosphate | 0 | 13 | |
| other | motion sickness | Ear and labyrinth disorders | Placebo (for Amifampridine Phosphate) | 1 | 13 | |
| other | diplopia | Eye disorders | Amifampridine Phosphate | 0 | 13 | |
| other | diplopia | Eye disorders | Placebo (for Amifampridine Phosphate) | 1 | 13 | |
| other | eyelid ptosis | Eye disorders | Amifampridine Phosphate | 0 | 13 | |
| other | eyelid ptosis | Eye disorders | Placebo (for Amifampridine Phosphate) | 1 | 13 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amifampridine Phosphate | 0 | 13 |
| Total, all-cause mortality | Placebo (for Amifampridine Phosphate) | 0 | 13 |
| Total, other adverse events | Amifampridine Phosphate | 3 | 13 |
| Total, other adverse events | Placebo (for Amifampridine Phosphate) | 10 | 13 |
| Total, serious adverse events | Amifampridine Phosphate | 0 | 13 |
| Total, serious adverse events | Placebo (for Amifampridine Phosphate) | 0 | 13 |
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 |
|---|---|
| Amifampridine Phosphate vs Placebo (for Amifampridine Phosphate): Triple Timed Up and Go Walk Test (3TUG) | Trial comparisons |
| Amifampridine Phosphate vs Placebo (for Amifampridine Phosphate): deaths from any cause | Trial comparisons |
| Amifampridine Phosphate vs Placebo (for 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.
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/NCT02970162
GET https://conductscience.org/api/trials/v1/NCT02970162/events?page=2