Lacosamide in Painful Diabetic Peripheral Neuropathy: A Phase 2 Double-blind Placebo-controlled Study

@article{Rauck2007LacosamideIP,
  title={Lacosamide in Painful Diabetic Peripheral Neuropathy: A Phase 2 Double-blind Placebo-controlled Study},
  author={Richard L. Rauck and Aziz I. Shaibani and Victor Biton and Jeffrey Simpson and B. Koch},
  journal={The Clinical Journal of Pain},
  year={2007},
  volume={23},
  pages={150-158}
}
BackgroundPeripheral diabetic neuropathy affects between 20% and 45% of patients with diabetes. ObjectiveTo ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy. MethodsOne hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥4 on the Likert pain scale entered the multicenter, randomized, double-blind, placebo-controlled trial. Lacosamide (N=60) titrated from 100 to 400 mg/d or maximum tolerated dose… 
Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial.
TLDR
Lacosamide treatment at a dose of 400 mg/day reduced diabetic neuropathic pain with a favorable safety and tolerability profile that may be suitable for patients with diabetes.
Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial
TLDR
This study will examine the concept of individualized therapy based on phenotyping, and expect that this study will provide important information on the usefulness of lacosamide in the treatment of peripheral neuropathic pain.
Efficacy and Safety of Lacosamide in Diabetic Neuropathic Pain: An 18-week Double-blind Placebo-controlled Trial of Fixed-dose Regimens
TLDR
Safety and efficacy analyses indicated that lacosamide 400 mg/d provided an optimal balance between efficacy and side effects in patients with painful diabetic neuropathy.
Lacosamide for neuropathic pain and fibromyalgia in adults.
TLDR
It is likely that lacosamide is without any useful benefit in treating neuropathic pain; any positive interpretation of the evidence should be made with caution if at all.
Impact of treatments for painful diabetic polyneuropathies on patients
TLDR
Patients with painful diabetic polyneuropathy (PDN) commonly report neuropathic pain symptoms, and amongst those classified as having no neuropathy according to the Toronto Clinical Neuropathy Scoring System, 7.4 % of 269 NIDDM patients with PDN experienced some degree of pain.
Pharmacologic interventions for painful diabetic neuropathy: An umbrella systematic review and comparative effectiveness network meta-analysis.
TLDR
Three head-to-head trials showed greater pain reduction associated with serotonin-norepinephrine reuptake inhibitors (SNRIs) than anticonvulsants, and several medications may be effective for short-term management of painful diabetic neuropathy, although their comparative effectiveness is unclear.
Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis.
TLDR
The placebo response for a decline in pain intensity and responder rate was smaller in trials that assessed central pain and postherpetic neuralgia (PHN) and larger in Trials that assessed HIV pain.
Painful Diabetic Neuropathy
TLDR
Chronic DPN with persistent or episodic pain that typically may worsen at night, and improve during walking, is localized predominantly in the feet, but there may be superimposed lancination, or it may be of burning thermal quality.
Lacosamide in patients with Nav1.7 mutations-related small fibre neuropathy: a randomized controlled trial
TLDR
It is shown that lacosamide has a significant effect on pain, general wellbeing, and sleep quality, and is well tolerated and safe in use, suggesting that it can be used for pain treatment in Nav1.7-related small fibre neuropathy.
Quality of Life in Painful Peripheral Neuropathies: A Systematic Review
TLDR
QoL is impaired in painful PN and should not be neglected in clinical practice, but patients' pain management and subsequent impact on QoL should routinely be assessed and monitored.
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 37 REFERENCES
Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial.
TLDR
Gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life.
Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial
TLDR
Pregabalin was safe and effective in decreasing pain associated with DPN, and also improved mood, sleep disturbance, and quality of life.
Duloxetine vs. placebo in patients with painful diabetic neuropathy
TLDR
Duloxetine at 60 and 120 mg/d was safe and effective in the management of diabetic peripheral neuropathic pain and separated from placebo on nearly all the secondary measures including health‐related outcome measures.
The Validity of the Neuropathic Pain Scale for Assessing Diabetic Neuropathic Pain in a Clinical Trial
TLDR
These findings support the utility of the NPS for characterizing the multidimensional nature of the neuropathic pain experience and for detecting changes in neuropathicPain with treatment.
Does SPM 927 have an analgesic effect in human neuropathic pain? An open label study
TLDR
SPM 927 may have an analgesic effect in human neuropathic pain and was reasonably well tolerated in this study, and data support the continued clinical development of the putative anticonvulsant for neuropathicPain.
A systematic review of antidepressants in neuropathic pain
TLDR
Antidepressants are effective in relieving neuropathic pain and it is still unclear which drug class should be first choice, with very similar results for anticonvulsants.
Epidemiology and Impact on Quality of Life of Postherpetic Neuralgia and Painful Diabetic Neuropathy
TLDR
Both conditions are common complications of their underlying disorders and can profoundly diminish the quality of life of affected persons.
[Effectiveness and safety of oxcarbazepine in chronic neuropathic pain: a study of 40 cases].
TLDR
OXC can be seen as a therapeutic alternative to be taken very much into account in patients with NP having different aetiologies; it has a good benefit-risk ratio and is a form of treatment that is well accepted by patients.
Practical Management of Patients With Painful Diabetic Neuropathy
TLDR
Current and essential tools for PDN assessment and management are provided, and recent advances in understanding the mechanisms underlying neuropathic pain should lead to better treatment and patient outcomes.
Clinically important changes in acute pain outcome measures: a validation study.
TLDR
The cut-off points determined for these pain scales provide a good surrogate measure of a patient-determined clinically important response and provide support for the usefulness of these values in future clinical trials of pain therapy.
...
1
2
3
4
...