Trial · NCT02450552
Clinical Trial of Ezogabine (Retigabine) in ALS Subjects
NCT02450552, Phase 2, Completed, Brian Wainger; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial of Ezogabine (Retigabine) in ALS Subjects. Trials, record NCT02450552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02450552
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Ezogabine (Retigabine) in ALS Subjects
- NCT number
- NCT02450552
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Brian Wainger
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Ezogabine, Placebo
- First posted
- 2015-05-21
- Last updated
- 2019-08-28
- Results first posted
- 2019-08-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Screening, Baseline, Week 6, Week 8 | Short-interval intracortical inhibition (SICI) or paired-pulse SICI is defined as the ratio of the response after a conditioning pulse equal to 80% of resting motor threshold (RMT) is administered 3 ms prior to the signaling pulse divided by motor evoked potential (MEP) amplitude. Transcranial magnetic stimulation (TMS) is a neurophysiologic test for assessing upper motor neuron function. Change in SICI will be assessed by transcranial magnetic stimulation (TMS) after treatment with 900 mg/day or 600 mg/day of ezogabine vs. matched oral placebo. |
| Secondary | Change in Resting Motor Evoked Potential (MEP) Threshold (Prespecified Secondary Outcome of Primary Importance) | Screening, Baseline, Week 6, Week 8 | Resting Motor Evoked Potential (MEP) is the magnetic field strength, measured as a percentage of the maximum stimulator output, that produces at least a 0.05 mV response in at least 5 of 10 consecutive trials.Change in resting MEP threshold will be assessed by Transcranial Magnetic Stimulation (TMS). |
| Secondary | Change in MEP Amplitude | Screening, Baseline, Week 6, Week 8 | Motor Evoked Potential (MEP) amplitude is defined as the response when a stimulus equal to 120% of Resting Motor Threshold (RMT) is administered. MEP amplitude is calculated as the geometric mean of replicate estimates. Change in MEP will be assessed by Transcranial Magnetic Stimulation (TMS). |
| Secondary | Change in Duration of Cortical Silent Period | Screening, Baseline, Week 6, Week 8 | Cortical silent period (CSP) is the suppression of voluntary muscle contraction elicited by stimulation equal to 120% of resting motor threshold (RMT). CSP duration is measured from the time of the muscle activity suppression to return of muscle activity. Change in duration of cortical silent period is assessed by Transcranial Magnetic Stimulation (TMS). |
| Secondary | Change in Intracortical Facilitation | Screening, Baseline, Week 6, Week 8 | Paired-pulse Intracortical facilitation (ICF) is defined as the ratio of the response after a conditioning pulse equal to 80% of Resting Motor Threshold (RMT) is administered 15 milliseconds prior to the signaling pulse divided by Motor Evoked Potential (MEP) amplitude. ICF is calculated as the geometric mean of replicate estimates. Change in intracortical facilitation is assessed by Transcranial Magnetic Stimulation (TMS). |
| Secondary | Change in Electrotonus | Screening, Baseline, Week 6, Week 8 | Change in depolarizing electrotonus at 90 to 100 milliseconds was assessed by threshold tracking axonal nerve conduction studies (TTNCS). TTNCS is a neurophysiologic test for assessing lower motor neuron function. |
| Secondary | Change in Strength Duration Time Constant | Screening, Baseline, Week 6, Week 8 | Assessed by threshold tracking axonal nerve conduction studies (TTNCS). |
| Secondary | Change in Recovery Cycle | Screening, Baseline, Week 6, Week 8 | Lower motor neuron excitability can be measured using change in recovery cycle of superexcitability. Change in recovery cycle of superexcitability after first pre-pulse is assessed by threshold tracking axonal nerve conduction studies (TTNCS). Threshold-tracking nerve conduction studies is a neurophysiologic test for assessing lower motor neuron function. |
| Secondary | Muscle Cramping Frequency | Week 1 through Week 10 | Frequency of muscle cramping and maximum pain from muscle cramping was collected by subjects via self-report using a daily muscle cramping diary. |
| Secondary | Hand Held Dynamometry Force Measurement for Abductor Pollicis Brevis | Screening, Baseline, Week 4, Week 6, Week 8, Week 12 | Hand held dynamometry (HHD) will be used as a quantitative measure of muscle strength of the abductor pollicis brevis (APB) muscle. HHD will be self-report by study participants using a daily muscle cramping diary. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Screening, Baseline, Week 6, Week 8 | As a result of electrophysiologic response, good quality data was defined based on the central reader's evaluation. | Unitless | MEAN |
| SECONDARY | Change in Resting Motor Evoked Potential (MEP) Threshold (Prespecified Secondary Outcome of Primary Importance) | Screening, Baseline, Week 6, Week 8 | Data of low quality may have been removed from the number of participants analyzed based on the central reader's evaluation. | percentage of the maximum output | MEAN |
| SECONDARY | Change in MEP Amplitude | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis as a result of the central reader's evaluation standards. | Millivolts | GEOMETRIC_MEAN |
| SECONDARY | Change in Duration of Cortical Silent Period | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis population as a result of the central reader's evaluation standards. | Milliseconds | MEAN |
| SECONDARY | Change in Intracortical Facilitation | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis population as a result of the central reader's evaluation standards. | Unitless | GEOMETRIC_MEAN |
| SECONDARY | Change in Electrotonus | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis population as a result of the central reader's evaluation standards. | percentage of threshold | MEAN |
| SECONDARY | Change in Strength Duration Time Constant | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis population as a result of the central reader's evaluation standards. | Milliseconds | MEAN |
| SECONDARY | Change in Recovery Cycle | Screening, Baseline, Week 6, Week 8 | Data of low quality were removed from analysis as a result of the central reader's evaluation standards. | percentage of threshold | MEAN |
| SECONDARY | Muscle Cramping Frequency | Week 1 through Week 10 | Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points. | Days | MEAN |
| SECONDARY | Hand Held Dynamometry Force Measurement for Abductor Pollicis Brevis | Screening, Baseline, Week 4, Week 6, Week 8, Week 12 | Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points. | kilograms (kg) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group177
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 900 mg/Day | Screening | 1.180 | Standard Deviation 1.108 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 600 mg/Day | Screening | 0.965 | Standard Deviation 1.302 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Placebo | Screening | 0.784 | Standard Deviation 0.560 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 900 mg/Day | Baseline | 1.347 | Standard Deviation 1.662 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 600 mg/Day | Baseline | 0.952 | Standard Deviation 1.138 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Placebo | Baseline | 0.755 | Standard Deviation 0.539 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 900 mg/Day | Week 6 | 1.100 | Standard Deviation 1.066 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 600 mg/Day | Week 6 | 0.675 | Standard Deviation 0.613 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Placebo | Week 6 | 0.777 | Standard Deviation 0.442 | Unitless |
| Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS) | Oral Ezogabine 900 mg/Day | Week 8 | 0.948 | Standard Deviation 1.169 | Unitless |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Ezogabine 900 mg/Day | 19 | |
| Overall Study | STARTED | Oral Ezogabine 600 mg/Day | 23 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Oral Ezogabine 900 mg/Day | 14 | |
| Overall Study | COMPLETED | Oral Ezogabine 600 mg/Day | 23 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Oral Ezogabine 900 mg/Day | 5 | |
| Overall Study | NOT COMPLETED | Oral Ezogabine 600 mg/Day | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events225
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 | Vertigo | Ear and labyrinth disorders | Oral Ezogabine 900 mg/Day | 1 | 19 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Oral Ezogabine 600 mg/Day | 0 | 23 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 23 | 1 |
| other | Vision Blurred | Eye disorders | Oral Ezogabine 900 mg/Day | 2 | 19 | 2 |
| other | Vision Blurred | Eye disorders | Oral Ezogabine 600 mg/Day | 1 | 23 | 1 |
| other | Vision Blurred | Eye disorders | Placebo | 2 | 23 | 2 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Oral Ezogabine 900 mg/Day | 1 | 19 | 1 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Oral Ezogabine 600 mg/Day | 0 | 23 | 0 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Placebo | 0 | 23 | 0 |
| other | Constipation | Gastrointestinal disorders | Oral Ezogabine 900 mg/Day | 4 | 19 | 4 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Ezogabine 900 mg/Day | 0 | 19 |
| Total, all-cause mortality | Oral Ezogabine 600 mg/Day | 0 | 23 |
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, other adverse events | Oral Ezogabine 900 mg/Day | 19 | 19 |
| Total, other adverse events | Oral Ezogabine 600 mg/Day | 23 | 23 |
| Total, other adverse events | Placebo | 23 | 23 |
| Total, serious adverse events | Oral Ezogabine 900 mg/Day | 1 | 19 |
| Total, serious adverse events | Oral Ezogabine 600 mg/Day | 2 | 23 |
| Total, serious adverse events | Placebo | 0 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33226425 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02450552
GET https://conductscience.org/api/trials/v1/NCT02450552/results?page=2