Page last updated: 2024-10-16

carbamates and ALS - Amyotrophic Lateral Sclerosis

carbamates has been researched along with ALS - Amyotrophic Lateral Sclerosis in 5 studies

Research Excerpts

ExcerptRelevanceReference
"In recent years several new treatments have been introduced in neurology, sumatriptan in migraine, riluzole in amyotrophic lateral sclerosis, interferon-beta in multiple sclerosis and rivastigmine in Alzheimer's disease."4.80[New therapies in neurology, but who benefits?]. ( de Haan, RJ; Vermeulen, M, 1999)

Research

Studies (5)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (20.00)18.2507
2000's0 (0.00)29.6817
2010's2 (40.00)24.3611
2020's2 (40.00)2.80

Authors

AuthorsStudies
Sleutjes, BTHM2
Stikvoort GarcĂ­a, DJL1
Kovalchuk, MO2
Heuberger, JAAC2
Groeneveld, GJ2
Franssen, H2
van den Berg, LH2
Wainger, BJ2
Macklin, EA1
Vucic, S1
McIlduff, CE1
Paganoni, S1
Maragakis, NJ1
Bedlack, R1
Goyal, NA1
Rutkove, SB1
Lange, DJ1
Rivner, MH1
Goutman, SA1
Ladha, SS1
Mauricio, EA1
Baloh, RH1
Simmons, Z1
Pothier, L1
Kassis, SB1
La, T1
Hall, M1
Evora, A1
Klements, D1
Hurtado, A1
Pereira, JD1
Koh, J1
Celnik, PA1
Chaudhry, V1
Gable, K1
Juel, VC1
Phielipp, N1
Marei, A1
Rosenquist, P1
Meehan, S1
Oskarsson, B1
Lewis, RA1
Kaur, D1
Kiskinis, E1
Woolf, CJ2
Eggan, K2
Weiss, MD1
Berry, JD1
David, WS1
Davila-Perez, P1
Camprodon, JA1
Pascual-Leone, A1
Kiernan, MC1
Shefner, JM1
Atassi, N1
Cudkowicz, ME1
Ziagkos, D1
Ferguson, TA1
McNeish, J1
Gardner, JP1
Vermeulen, M1
de Haan, RJ1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral Sclerosis[NCT02450552]Phase 265 participants (Actual)Interventional2015-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants Who Tolerate Study Drug

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. (NCT02450552)
Timeframe: 10 weeks

InterventionParticipants (Count of Participants)
Oral Ezogabine 900 mg/Day14
Oral Ezogabine 600 mg/Day11
Placebo23

Change in Duration of Cortical Silent Period

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). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
InterventionMilliseconds (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day69.27376.00674.91758.870
Oral Ezogabine 900 mg/Day99.54280.22396.84488.000
Placebo88.83180.63883.47987.479

Change in Electrotonus

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. (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
Interventionpercentage of threshold (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day48.14448.90151.85748.552
Oral Ezogabine 900 mg/Day52.27546.27850.18750.108
Placebo44.53246.57444.89847.010

Change in Intracortical Facilitation

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). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
InterventionUnitless (Geometric Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day1.8492.0731.5351.466
Oral Ezogabine 900 mg/Day1.8292.4201.8941.779
Placebo1.6531.5311.5711.514

Change in MEP Amplitude

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). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
InterventionMillivolts (Geometric Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day1.2100.9540.9141.129
Oral Ezogabine 900 mg/Day0.6390.3951.780.571
Placebo0.8451.0980.4540.450

Change in Recovery Cycle

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. (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
Interventionpercentage of threshold (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day-28.12-27.40-37.48-33.15
Oral Ezogabine 900 mg/Day-30.45-31.39-37.59-38.20
Placebo-27.77-28.16-28.37-29.26

Change in Resting Motor Evoked Potential (MEP) Threshold (Prespecified Secondary Outcome of Primary Importance)

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). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
Interventionpercentage of the maximum output (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day52.00054.25057.58356.700
Oral Ezogabine 900 mg/Day51.25048.38550.11146.00
Placebo56.30857.23154.71455.357

Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS)

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. (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
InterventionUnitless (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day0.9650.9520.6750.617
Oral Ezogabine 900 mg/Day1.1801.3471.1000.948
Placebo0.7840.7550.7770.834

Change in Strength Duration Time Constant

Assessed by threshold tracking axonal nerve conduction studies (TTNCS). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8

,,
InterventionMilliseconds (Mean)
ScreeningBaselineWeek 6Week 8
Oral Ezogabine 600 mg/Day0.4510.4540.4800.461
Oral Ezogabine 900 mg/Day0.5210.5220.4160.341
Placebo0.5050.4880.5460.497

Hand Held Dynamometry Force Measurement for Abductor Pollicis Brevis

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. (NCT02450552)
Timeframe: Screening, Baseline, Week 4, Week 6, Week 8, Week 12

,,
Interventionkilograms (kg) (Mean)
ScreeningBaselineWeek 4Week 6Week 8Week 12
Oral Ezogabine 600 mg/Day8.5776.6417.3336.9215.6335.439
Oral Ezogabine 900 mg/Day6.7216.5846.4616.8387.0155.887
Placebo7.4487.1646.6866.3006.5235.643

Muscle Cramping Frequency

Frequency of muscle cramping and maximum pain from muscle cramping was collected by subjects via self-report using a daily muscle cramping diary. (NCT02450552)
Timeframe: Week 1 through Week 10

,,
InterventionDays (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10
Oral Ezogabine 600 mg/Day8.7387.0837.7509.13510.2658.3339.7149.0679.93310.188
Oral Ezogabine 900 mg/Day12.1769.23510.90612.01812.53311.0339.40011.21112.78613.179
Placebo9.5368.27310.170106.198.9558.5399.6099.28211.19013.600

Proportion of Days With Fasciculations

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. (NCT02450552)
Timeframe: Week 1 through Week 10

,,
InterventionProportion of Days (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10
Oral Ezogabine 600 mg/Day0.6590.6370.6480.6370.6590.7140.7670.6880.6570.700
Oral Ezogabine 900 mg/Day0.9180.9180.7960.7520.8790.8680.9120.8680.8930.869
Placebo0.7450.7760.8160.8060.7330.7650.7860.7140.8570.813

Reviews

1 review available for carbamates and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
[New therapies in neurology, but who benefits?].
    Nederlands tijdschrift voor geneeskunde, 1999, Aug-28, Volume: 143, Issue:35

    Topics: Alzheimer Disease; Amyotrophic Lateral Sclerosis; Antiviral Agents; Carbamates; Humans; Interferon-b

1999

Trials

2 trials available for carbamates and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
Effect of Ezogabine on Cortical and Spinal Motor Neuron Excitability in Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial.
    JAMA neurology, 2021, 02-01, Volume: 78, Issue:2

    Topics: Aged; Amyotrophic Lateral Sclerosis; Anticonvulsants; Carbamates; Cerebral Cortex; Dose-Response Rel

2021
Acute Effects of Riluzole and Retigabine on Axonal Excitability in Patients With Amyotrophic Lateral Sclerosis: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.
    Clinical pharmacology and therapeutics, 2018, Volume: 104, Issue:6

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Axons; Carbamates; Cross-Over Studies; Double-Blind Meth

2018

Other Studies

2 other studies available for carbamates and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
Acute retigabine-induced effects on myelinated motor axons in amyotrophic lateral sclerosis.
    Pharmacology research & perspectives, 2022, Volume: 10, Issue:4

    Topics: Amyotrophic Lateral Sclerosis; Axons; Carbamates; Humans; Motor Neurons; Phenylenediamines

2022
From Dish to Bedside: Lessons Learned While Translating Findings from a Stem Cell Model of Disease to a Clinical Trial.
    Cell stem cell, 2015, Jul-02, Volume: 17, Issue:1

    Topics: Amyotrophic Lateral Sclerosis; Animals; Carbamates; Clinical Trials as Topic; Drug Discovery; Humans

2015