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Trial record 1 of 1 for:    NCT02450552
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Clinical Trial of Ezogabine (Retigabine) in ALS Subjects

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ClinicalTrials.gov Identifier: NCT02450552
Recruitment Status : Completed
First Posted : May 21, 2015
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
ALS Association
GlaxoSmithKline
Harvard University
Massachusetts General Hospital
Information provided by (Responsible Party):
Brian Wainger, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Interventions Drug: Ezogabine
Drug: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Placebo: Matched placebo
Period Title: Overall Study
Started 19 23 23
Completed 14 23 18
Not Completed 5 0 5
Reason Not Completed
Withdrawal by Subject             4             0             4
Physician Decision             1             0             1
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo Total
Hide Arm/Group Description Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Placebo: Matched placebo Total of all reporting groups
Overall Number of Baseline Participants 19 23 23 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 23 participants 23 participants 65 participants
58.91  (9.10) 57.4  (8.01) 58.1  (9.55) 58.34  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 23 participants 65 participants
Female
6
  31.6%
10
  43.5%
4
  17.4%
20
  30.8%
Male
13
  68.4%
13
  56.5%
19
  82.6%
45
  69.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 23 participants 65 participants
Hispanic or Latino
0
   0.0%
1
   4.3%
1
   4.3%
2
   3.1%
Not Hispanic or Latino
19
 100.0%
22
  95.7%
22
  95.7%
63
  96.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 23 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.3%
0
   0.0%
0
   0.0%
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.3%
0
   0.0%
0
   0.0%
1
   1.5%
White
17
  89.5%
23
 100.0%
23
 100.0%
63
  96.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 23 participants 23 participants 65 participants
19
 100.0%
23
 100.0%
23
 100.0%
65
 100.0%
1.Primary Outcome
Title Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS)
Hide Description 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.
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
As a result of electrophysiologic response, good quality data was defined based on the central reader's evaluation.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: Unitless
Screening Number Analyzed 12 participants 11 participants 13 participants
1.180  (1.108) 0.965  (1.302) 0.784  (0.560)
Baseline Number Analyzed 13 participants 16 participants 13 participants
1.347  (1.662) 0.952  (1.138) 0.755  (0.539)
Week 6 Number Analyzed 9 participants 12 participants 14 participants
1.100  (1.066) 0.675  (0.613) 0.777  (0.442)
Week 8 Number Analyzed 8 participants 10 participants 15 participants
0.948  (1.169) 0.617  (0.455) 0.834  (0.488)
2.Secondary Outcome
Title Change in Resting Motor Evoked Potential (MEP) Threshold (Prespecified Secondary Outcome of Primary Importance)
Hide Description 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).
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality may have been removed from the number of participants analyzed based on the central reader's evaluation.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: percentage of the maximum output
Screening Number Analyzed 12 participants 11 participants 13 participants
51.250  (14.379) 52.000  (11.480) 56.308  (13.804)
Baseline Number Analyzed 13 participants 16 participants 13 participants
48.385  (14.373) 54.250  (11.018) 57.231  (13.498)
Week 6 Number Analyzed 9 participants 12 participants 14 participants
50.111  (14.066) 57.583  (15.365) 54.714  (12.313)
Week 8 Number Analyzed 8 participants 10 participants 14 participants
46.00  (10.876) 56.700  (13.039) 55.357  (10.149)
3.Secondary Outcome
Title Change in MEP Amplitude
Hide Description 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).
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Geometric Mean (Standard Deviation)
Unit of Measure: Millivolts
Screening Number Analyzed 12 participants 11 participants 13 participants
0.639  (0.635) 1.210  (1.958) 0.845  (0.626)
Baseline Number Analyzed 13 participants 16 participants 13 participants
0.395  (0.282) 0.954  (1.402) 1.098  (1.197)
Week 6 Number Analyzed 9 participants 12 participants 14 participants
1.78  (1.568) 0.914  (0.861) 0.454  (0.339)
Week 8 Number Analyzed 8 participants 10 participants 14 participants
0.571  (0.345) 1.129  (0.600) 0.450  (0.299)
4.Secondary Outcome
Title Change in Duration of Cortical Silent Period
Hide Description 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).
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: Milliseconds
Screening Number Analyzed 12 participants 11 participants 13 participants
99.542  (39.153) 69.273  (29.921) 88.831  (39.519)
Baseline Number Analyzed 13 participants 16 participants 13 participants
80.223  (23.440) 76.006  (30.459) 80.638  (32.894)
Week 6 Number Analyzed 9 participants 12 participants 14 participants
96.844  (43.426) 74.917  (36.338) 83.479  (32.920)
Week 8 Number Analyzed 8 participants 10 participants 14 participants
88.000  (32.258) 58.870  (21761) 87.479  (39.839)
5.Secondary Outcome
Title Change in Intracortical Facilitation
Hide Description 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).
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Geometric Mean (Standard Deviation)
Unit of Measure: Unitless
Screening Number Analyzed 13 participants 11 participants 13 participants
1.829  (0.862) 1.849  (1.669) 1.653  (0.907)
Baseline Number Analyzed 13 participants 16 participants 13 participants
2.420  (2.356) 2.073  (2.075) 1.531  (0.906)
Week 6 Number Analyzed 9 participants 12 participants 14 participants
1.894  (1.177) 1.535  (1.472) 1.571  (1.298)
Week 8 Number Analyzed 8 participants 10 participants 14 participants
1.779  (1.627) 1.466  (0.836) 1.514  (0.817)
6.Secondary Outcome
Title Change in Electrotonus
Hide Description 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.
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: percentage of threshold
Screening Number Analyzed 14 participants 18 participants 21 participants
52.275  (14.924) 48.144  (8.636) 44.532  (6.666)
Baseline Number Analyzed 14 participants 19 participants 18 participants
46.278  (7.663) 48.901  (9.327) 46.574  (6.689)
Week 6 Number Analyzed 10 participants 13 participants 18 participants
50.187  (6.645) 51.857  (7.303) 44.898  (6.082)
Week 8 Number Analyzed 7 participants 12 participants 16 participants
50.108  (2.533) 48.552  (13.422) 47.010  (6.212)
7.Secondary Outcome
Title Change in Strength Duration Time Constant
Hide Description Assessed by threshold tracking axonal nerve conduction studies (TTNCS).
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: Milliseconds
Screening Number Analyzed 14 participants 18 participants 20 participants
0.521  (0.084) 0.451  (0.096) 0.505  (0.086)
Baseline Number Analyzed 14 participants 20 participants 19 participants
0.522  (0.084) 0.454  (0.084) 0.488  (0.078)
Week 6 Number Analyzed 10 participants 13 participants 19 participants
0.416  (0.141) 0.480  (0.165) 0.546  (0.120)
Week 8 Number Analyzed 7 participants 13 participants 16 participants
0.341  (0.079) 0.461  (0.134) 0.497  (0.173)
8.Secondary Outcome
Title Change in Recovery Cycle
Hide Description 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.
Time Frame Screening, Baseline, Week 6, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data of low quality were removed from analysis as a result of the central reader's evaluation standards.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: percentage of threshold
Screening Number Analyzed 14 participants 18 participants 20 participants
-30.45  (8.694) -28.12  (8.401) -27.77  (7.955)
Baseline Number Analyzed 13 participants 19 participants 19 participants
-31.39  (6.896) -27.40  (6.993) -28.16  (7.589)
Week 6 Number Analyzed 9 participants 12 participants 18 participants
-37.59  (5.066) -37.48  (7.451) -28.37  (7.835)
Week 8 Number Analyzed 5 participants 12 participants 15 participants
-38.20  (4.965) -33.15  (13.874) -29.26  (5.880)
9.Secondary Outcome
Title Muscle Cramping Frequency
Hide Description Frequency of muscle cramping and maximum pain from muscle cramping was collected by subjects via self-report using a daily muscle cramping diary.
Time Frame Week 1 through Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: Days
Week 1 Number Analyzed 17 participants 21 participants 22 participants
12.176  (15.233) 8.738  (14.477) 9.536  (15.909)
Week 2 Number Analyzed 17 participants 20 participants 22 participants
9.235  (11.729) 7.083  (11.558) 8.273  (10.968)
Week 3 Number Analyzed 17 participants 20 participants 22 participants
10.906  (13.532) 7.750  (12.268) 10.170  (13.915)
Week 4 Number Analyzed 17 participants 20 participants 22 participants
12.018  (18.824) 9.135  (12.664) 106.19  (14.016)
Week 5 Number Analyzed 15 participants 17 participants 22 participants
12.533  (15.824) 10.265  (13.404) 8.955  (13.268)
Week 6 Number Analyzed 15 participants 15 participants 23 participants
11.033  (11.705) 8.333  (10.887) 8.539  (10.869)
Week 7 Number Analyzed 15 participants 14 participants 23 participants
9.400  (10.716) 9.714  (12.755) 9.609  (12.551)
Week 8 Number Analyzed 15 participants 15 participants 22 participants
11.211  (13.521) 9.067  (11.151) 9.282  (12.244)
Week 9 Number Analyzed 14 participants 15 participants 21 participants
12.786  (14.154) 9.933  (11.750) 11.190  (16.162)
Week 10 Number Analyzed 14 participants 16 participants 20 participants
13.179  (14.953) 10.188  (12.296) 13.600  (16.162)
10.Secondary Outcome
Title Hand Held Dynamometry Force Measurement for Abductor Pollicis Brevis
Hide Description 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.
Time Frame Screening, Baseline, Week 4, Week 6, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
Screening Number Analyzed 19 participants 22 participants 21 participants
6.721  (4.548) 8.577  (6.927) 7.448  (4.048)
Baseline Number Analyzed 19 participants 22 participants 22 participants
6.584  (4.022) 6.641  (4.901) 7.164  (4.716)
Week 4 Number Analyzed 18 participants 21 participants 22 participants
6.461  (4.002) 7.333  (5.839) 6.686  (5.115)
Week 6 Number Analyzed 16 participants 19 participants 22 participants
6.838  (3.569) 6.921  (5.570) 6.300  (5.167)
Week 8 Number Analyzed 13 participants 18 participants 22 participants
7.015  (4.398) 5.633  (4.015) 6.523  (4.523)
Week 12 Number Analyzed 15 participants 18 participants 21 participants
5.887  (3.696) 5.439  (3.609) 5.643  (4.523)
11.Secondary Outcome
Title Proportion of Days With Fasciculations
Hide Description For the purpose of this study, a fasciculation is a brief, spontaneous contraction affecting a small number of muscle fibers, often causing a flicker of movement under the skin. Defining interference with daily activities may be different for each subject and defining daily activities will be different for each subject. Subjects will self report by diary, days with fasciculations.
Time Frame Week 1 through Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Mean (Standard Deviation)
Unit of Measure: Proportion of Days
Week 1 Number Analyzed 14 participants 13 participants 14 participants
0.918  (0.134) 0.659  (0.415) 0.745  (0.368)
Week 2 Number Analyzed 14 participants 13 participants 14 participants
0.918  (0.229) 0.637  (0.435) 0.776  (0.325)
Week 3 Number Analyzed 14 participants 13 participants 14 participants
0.796  (0.366) 0.648  (0.439) 0.816  (0.334)
Week 4 Number Analyzed 14 participants 13 participants 14 participants
0.752  (0.352) 0.637  (0.450) 0.806  (0.348)
Week 5 Number Analyzed 13 participants 13 participants 15 participants
0.879  (0.285) 0.659  (0.461) 0.733  (0.374)
Week 6 Number Analyzed 13 participants 11 participants 14 participants
0.868  (0.288) 0.714  (0.438) 0.765  (0.418)
Week 7 Number Analyzed 13 participants 10 participants 14 participants
0.912  (0.277) 0.767  (0.417) 0.786  (0.379)
Week 8 Number Analyzed 13 participants 11 participants 15 participants
0.868  (0.294) 0.688  (0.460) 0.714  (0.432)
Week 9 Number Analyzed 12 participants 10 participants 14 participants
0.893  (0.293) 0.657  (0.472) 0.857  (0.296)
Week 10 Number Analyzed 12 participants 10 participants 13 participants
0.869  (0.319) 0.700  (0.483) 0.813  (0.380)
12.Secondary Outcome
Title Number of Participants Who Tolerate Study Drug
Hide Description Participants will be judged tolerant of study drug if they reached their target dose and remain on study drug until planned discontinuation. Tolerability will be summarized as the proportion of participants in a treatment group who are tolerant of study drug.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description:
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
Placebo: Matched placebo
Overall Number of Participants Analyzed 19 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
14
  73.7%
11
  47.8%
23
 100.0%
Time Frame Adverse Events were collected from the date the first subject signed consent, November 30, 2015, to the date the last subject completed the last study visit, February 27, 2018, a total of about 2 years, 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Hide Arm/Group Description Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Ezogabine: Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. Placebo: Matched placebo
All-Cause Mortality
Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/23 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      2/23 (8.70%)      0/23 (0.00%)    
Infections and infestations       
Influenza  1  0/19 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
Pneumonia  1  0/19 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
Nervous system disorders       
Cerebrovascular Accident  1  0/19 (0.00%)  0 1/23 (4.35%)  1 0/23 (0.00%)  0
Depressed Level of Consciousness  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Ezogabine 900 mg/Day Oral Ezogabine 600 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      23/23 (100.00%)      23/23 (100.00%)    
Ear and labyrinth disorders       
Vertigo  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Eye disorders       
Vision Blurred  1  2/19 (10.53%)  2 1/23 (4.35%)  1 2/23 (8.70%)  2
Gastrointestinal disorders       
Abdominal Pain Lower  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Constipation  1  4/19 (21.05%)  4 3/23 (13.04%)  3 2/23 (8.70%)  2
Diarrhoea  1  2/19 (10.53%)  2 2/23 (8.70%)  2 1/23 (4.35%)  1
Dry Mouth  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Hypoaesthesia Oral  1  2/19 (10.53%)  2 1/23 (4.35%)  1 0/23 (0.00%)  0
Nausea  1  0/19 (0.00%)  0 3/23 (13.04%)  6 3/23 (13.04%)  3
Paraesthesia Oral  1  1/19 (5.26%)  1 3/23 (13.04%)  5 0/23 (0.00%)  0
Tongue Disorder  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Hypersecretion  2  0/19 (0.00%)  0 2/23 (8.70%)  2 2/23 (8.70%)  2
General disorders       
Asthenia  1  2/19 (10.53%)  2 3/23 (13.04%)  3 0/23 (0.00%)  0
Fatigue  1  7/19 (36.84%)  7 11/23 (47.83%)  12 6/23 (26.09%)  6
Gait Disturbance  1  2/19 (10.53%)  2 1/23 (4.35%)  1 0/23 (0.00%)  0
Oedema Peripheral  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Pain  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Pyrexia  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Infections and infestations       
Bacterial Infection  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Nasopharyngitis  1  1/19 (5.26%)  1 0/23 (0.00%)  0 2/23 (8.70%)  2
Upper Respiratory Tract Infection  1  2/19 (10.53%)  2 1/23 (4.35%)  1 0/23 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Fall  1  4/19 (21.05%)  5 7/23 (30.43%)  7 4/23 (17.39%)  7
Head Injury  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Poisoning  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Post Lumbar Puncture Syndrome  1  0/19 (0.00%)  0 2/23 (8.70%)  2 0/23 (0.00%)  0
Skin Abrasion  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Investigations       
Alanine Aminotransferase Increased  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Aspartate Aminotransferase Increased  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Bacterial Test  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Crystal Urine Present  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Electrocardiogram Qt Prolonged  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Weight Decreased  1  0/19 (0.00%)  0 2/23 (8.70%)  2 0/23 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  1  0/19 (0.00%)  0 2/23 (8.70%)  2 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/19 (5.26%)  1 2/23 (8.70%)  2 1/23 (4.35%)  1
Back Pain  1  1/19 (5.26%)  1 1/23 (4.35%)  1 1/23 (4.35%)  1
Muscle Spasms  1  2/19 (10.53%)  2 2/23 (8.70%)  2 5/23 (21.74%)  6
Muscular Weakness  1  2/19 (10.53%)  3 2/23 (8.70%)  2 3/23 (13.04%)  4
Musculoskeletal Chest Pain  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Musculoskeletal Discomfort  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Myalgia  1  0/19 (0.00%)  0 2/23 (8.70%)  2 1/23 (4.35%)  1
Nervous system disorders       
Aura  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Balance Disorder  1  2/19 (10.53%)  2 1/23 (4.35%)  1 0/23 (0.00%)  0
Cognitive Disorder  1  1/19 (5.26%)  2 1/23 (4.35%)  2 1/23 (4.35%)  1
Dizziness  1  8/19 (42.11%)  9 5/23 (21.74%)  6 3/23 (13.04%)  3
Dysarthria  1  2/19 (10.53%)  2 2/23 (8.70%)  2 0/23 (0.00%)  0
Dysstasia  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Headache  1  2/19 (10.53%)  2 1/23 (4.35%)  3 5/23 (21.74%)  6
Language Disorder  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Memory Impairment  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Muscle Contractions Involuntary  1  3/19 (15.79%)  3 2/23 (8.70%)  2 1/23 (4.35%)  1
Somnolence  1  7/19 (36.84%)  7 2/23 (8.70%)  2 1/23 (4.35%)  1
Speech Disorder  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Syncope  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Psychiatric disorders       
Confusional State  1  3/19 (15.79%)  3 1/23 (4.35%)  1 0/23 (0.00%)  0
Depression  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Disorientation  1  1/19 (5.26%)  3 1/23 (4.35%)  2 0/23 (0.00%)  0
Euphoric Mood  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Hallucination, Visual  1  4/19 (21.05%)  5 0/23 (0.00%)  0 0/23 (0.00%)  0
Mental Status Changes  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Perseveration  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Renal and urinary disorders       
Chromaturia  1  2/19 (10.53%)  2 2/23 (8.70%)  2 0/23 (0.00%)  0
Urinary Hesitation  1  1/19 (5.26%)  1 0/23 (0.00%)  0 1/23 (4.35%)  1
Urinary Retention  1  0/19 (0.00%)  0 4/23 (17.39%)  5 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/19 (5.26%)  1 4/23 (17.39%)  5 0/23 (0.00%)  0
Increased Viscosity Of Bronchial Secretion  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Oropharyngeal Pain  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Sinus Congestion  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Upper-Airway Cough Syndrome  1  1/19 (5.26%)  1 1/23 (4.35%)  1 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis Allergic  1  1/19 (5.26%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Erythema  1  1/19 (5.26%)  2 2/23 (8.70%)  5 1/23 (4.35%)  3
Rash  1  0/19 (0.00%)  0 2/23 (8.70%)  2 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA 17.1
2
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Protocol Investigator
Organization: Massachusetts General Hospital - Neurological Clinical Research Institute
Phone: 617-726-2000
EMail: Brian.Wainger@MGH.HARVARD.EDU
Layout table for additonal information
Responsible Party: Brian Wainger, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02450552    
Other Study ID Numbers: 2014D002776
First Submitted: May 19, 2015
First Posted: May 21, 2015
Results First Submitted: January 8, 2019
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019