carbamates has been researched along with ALS - Amyotrophic Lateral Sclerosis in 5 studies
Excerpt | Relevance | Reference |
---|---|---|
"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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (20.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 2 (40.00) | 24.3611 |
2020's | 2 (40.00) | 2.80 |
Authors | Studies |
---|---|
Sleutjes, BTHM | 2 |
Stikvoort GarcĂa, DJL | 1 |
Kovalchuk, MO | 2 |
Heuberger, JAAC | 2 |
Groeneveld, GJ | 2 |
Franssen, H | 2 |
van den Berg, LH | 2 |
Wainger, BJ | 2 |
Macklin, EA | 1 |
Vucic, S | 1 |
McIlduff, CE | 1 |
Paganoni, S | 1 |
Maragakis, NJ | 1 |
Bedlack, R | 1 |
Goyal, NA | 1 |
Rutkove, SB | 1 |
Lange, DJ | 1 |
Rivner, MH | 1 |
Goutman, SA | 1 |
Ladha, SS | 1 |
Mauricio, EA | 1 |
Baloh, RH | 1 |
Simmons, Z | 1 |
Pothier, L | 1 |
Kassis, SB | 1 |
La, T | 1 |
Hall, M | 1 |
Evora, A | 1 |
Klements, D | 1 |
Hurtado, A | 1 |
Pereira, JD | 1 |
Koh, J | 1 |
Celnik, PA | 1 |
Chaudhry, V | 1 |
Gable, K | 1 |
Juel, VC | 1 |
Phielipp, N | 1 |
Marei, A | 1 |
Rosenquist, P | 1 |
Meehan, S | 1 |
Oskarsson, B | 1 |
Lewis, RA | 1 |
Kaur, D | 1 |
Kiskinis, E | 1 |
Woolf, CJ | 2 |
Eggan, K | 2 |
Weiss, MD | 1 |
Berry, JD | 1 |
David, WS | 1 |
Davila-Perez, P | 1 |
Camprodon, JA | 1 |
Pascual-Leone, A | 1 |
Kiernan, MC | 1 |
Shefner, JM | 1 |
Atassi, N | 1 |
Cudkowicz, ME | 1 |
Ziagkos, D | 1 |
Ferguson, TA | 1 |
McNeish, J | 1 |
Gardner, JP | 1 |
Vermeulen, M | 1 |
de Haan, RJ | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral Sclerosis[NCT02450552] | Phase 2 | 65 participants (Actual) | Interventional | 2015-06-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | Participants (Count of Participants) |
---|---|
Oral Ezogabine 900 mg/Day | 14 |
Oral Ezogabine 600 mg/Day | 11 |
Placebo | 23 |
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
Intervention | Milliseconds (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 69.273 | 76.006 | 74.917 | 58.870 |
Oral Ezogabine 900 mg/Day | 99.542 | 80.223 | 96.844 | 88.000 |
Placebo | 88.831 | 80.638 | 83.479 | 87.479 |
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
Intervention | percentage of threshold (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 48.144 | 48.901 | 51.857 | 48.552 |
Oral Ezogabine 900 mg/Day | 52.275 | 46.278 | 50.187 | 50.108 |
Placebo | 44.532 | 46.574 | 44.898 | 47.010 |
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
Intervention | Unitless (Geometric Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 1.849 | 2.073 | 1.535 | 1.466 |
Oral Ezogabine 900 mg/Day | 1.829 | 2.420 | 1.894 | 1.779 |
Placebo | 1.653 | 1.531 | 1.571 | 1.514 |
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
Intervention | Millivolts (Geometric Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 1.210 | 0.954 | 0.914 | 1.129 |
Oral Ezogabine 900 mg/Day | 0.639 | 0.395 | 1.78 | 0.571 |
Placebo | 0.845 | 1.098 | 0.454 | 0.450 |
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
Intervention | percentage of threshold (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 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 |
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
Intervention | percentage of the maximum output (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 52.000 | 54.250 | 57.583 | 56.700 |
Oral Ezogabine 900 mg/Day | 51.250 | 48.385 | 50.111 | 46.00 |
Placebo | 56.308 | 57.231 | 54.714 | 55.357 |
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
Intervention | Unitless (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 0.965 | 0.952 | 0.675 | 0.617 |
Oral Ezogabine 900 mg/Day | 1.180 | 1.347 | 1.100 | 0.948 |
Placebo | 0.784 | 0.755 | 0.777 | 0.834 |
Assessed by threshold tracking axonal nerve conduction studies (TTNCS). (NCT02450552)
Timeframe: Screening, Baseline, Week 6, Week 8
Intervention | Milliseconds (Mean) | |||
---|---|---|---|---|
Screening | Baseline | Week 6 | Week 8 | |
Oral Ezogabine 600 mg/Day | 0.451 | 0.454 | 0.480 | 0.461 |
Oral Ezogabine 900 mg/Day | 0.521 | 0.522 | 0.416 | 0.341 |
Placebo | 0.505 | 0.488 | 0.546 | 0.497 |
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
Intervention | kilograms (kg) (Mean) | |||||
---|---|---|---|---|---|---|
Screening | Baseline | Week 4 | Week 6 | Week 8 | Week 12 | |
Oral Ezogabine 600 mg/Day | 8.577 | 6.641 | 7.333 | 6.921 | 5.633 | 5.439 |
Oral Ezogabine 900 mg/Day | 6.721 | 6.584 | 6.461 | 6.838 | 7.015 | 5.887 |
Placebo | 7.448 | 7.164 | 6.686 | 6.300 | 6.523 | 5.643 |
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
Intervention | Days (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | |
Oral Ezogabine 600 mg/Day | 8.738 | 7.083 | 7.750 | 9.135 | 10.265 | 8.333 | 9.714 | 9.067 | 9.933 | 10.188 |
Oral Ezogabine 900 mg/Day | 12.176 | 9.235 | 10.906 | 12.018 | 12.533 | 11.033 | 9.400 | 11.211 | 12.786 | 13.179 |
Placebo | 9.536 | 8.273 | 10.170 | 106.19 | 8.955 | 8.539 | 9.609 | 9.282 | 11.190 | 13.600 |
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
Intervention | Proportion of Days (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | |
Oral Ezogabine 600 mg/Day | 0.659 | 0.637 | 0.648 | 0.637 | 0.659 | 0.714 | 0.767 | 0.688 | 0.657 | 0.700 |
Oral Ezogabine 900 mg/Day | 0.918 | 0.918 | 0.796 | 0.752 | 0.879 | 0.868 | 0.912 | 0.868 | 0.893 | 0.869 |
Placebo | 0.745 | 0.776 | 0.816 | 0.806 | 0.733 | 0.765 | 0.786 | 0.714 | 0.857 | 0.813 |
1 review available for carbamates and ALS - Amyotrophic Lateral Sclerosis
Article | Year |
---|---|
[New therapies in neurology, but who benefits?].
Topics: Alzheimer Disease; Amyotrophic Lateral Sclerosis; Antiviral Agents; Carbamates; Humans; Interferon-b | 1999 |
2 trials available for carbamates and ALS - Amyotrophic Lateral Sclerosis
Article | Year |
---|---|
Effect of Ezogabine on Cortical and Spinal Motor Neuron Excitability in Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial.
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.
Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Axons; Carbamates; Cross-Over Studies; Double-Blind Meth | 2018 |
2 other studies available for carbamates and ALS - Amyotrophic Lateral Sclerosis
Article | Year |
---|---|
Acute retigabine-induced effects on myelinated motor axons in amyotrophic lateral sclerosis.
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.
Topics: Amyotrophic Lateral Sclerosis; Animals; Carbamates; Clinical Trials as Topic; Drug Discovery; Humans | 2015 |