Treatment Resistant Epilepsy and N-Acetyl Cysteine
关键词
抽象
描述
One third of patients with idiopathic autism have treatment resistant epilepsy, associated with earlier onset of seizures. In addition to insufficient response to medical treatment, they also have poorer responses to surgical and VNS approaches (Sansa et al 2011). Novel approaches to reduce seizure burden and improve quality of life for the children and their caregivers are needed.
There is a plethora of basic research documenting elevated oxidative stress in animal models of seizures. Several animal models have decreased oxidative stress through using compounds with antioxidant effects, but suprisingly, few human studies have been done to date.
This small open-label pilot study will examine the use of N-acetyl cysteine, an inexpensive but readily available over-the-counter nutritional supplement, to reduce seizure frequency in 10 youth with autism who have not responded completely to conventional anticonvulsant therapy
日期
| 最后验证: | 09/30/2015 |
| 首次提交: | 02/02/2014 |
| 提交的预估入学人数: | 02/02/2014 |
| 首次发布: | 02/03/2014 |
| 上次提交的更新: | 10/06/2015 |
| 最近更新发布: | 10/08/2015 |
| 实际学习开始日期: | 03/31/2013 |
| 预计主要完成日期: | 12/31/2014 |
| 预计完成日期: | 12/31/2014 |
状况或疾病
干预/治疗
Drug: N-Acetyl Cysteine (NAC)
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: N-Acetyl Cysteine (NAC) NAC will be started at 500 mg by mouth twice daily for the first 2 weeks, then increased to 500 mg in the am and 1000 mg in the pm for week 3, and then increased to 1000 mg am and pm for weeks 4 through 8. Subjects will be maintained at the highest tolerated dose. | Drug: N-Acetyl Cysteine (NAC) NAC will be started at 500 mg by mouth twice daily for the first 2 weeks, then increased to 500 mg in the am and 1000 mg in the pm for week 3, and then increased to 1000 mg am and pm for weeks 4 through 8. Subjects will be maintained at the highest tolerated dose. |
资格标准
| 有资格学习的年龄 | 6 Years 至 6 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Children and adolescents/young adults ages 6-21, male or female, all races and ethnicities. 2. Autism 3. IQ less than 80 4. 10 subjects with treatment resistant generalized epilepsy as defined by trials of 3 or more anticonvulsants with continued seizure frequency of at least 1 per week, need to use a helmet, or vagal nerve stimulator placement. 5. Children with at least 1 grand mal/generalized seizure per week. Exclusion Criteria: 1. Inability to swallow capsules 2. In females, pregnancy or sexual activity 3. Daily acetaminophen, glucocorticoid, or nonsteroidal anti-inflammatory drugs, or daily NAC or high-dose antioxidant vitamin supplements within 30 days of baseline. 4. History of acute or chronic liver, renal, endocrine, infectious, autoimmune, hematologic, metabolic, or other disorder in the judgement of the study physician. |
结果
主要结果指标
1. Recruitment rate [1 year]
次要成果指标
1. seizure frequency [up to 8 weeks]
其他成果措施
1. side effect rating form for children and adolescents [at baseline, 4, and 8 weeks]
2. Aberrant Behavior Checklist [baseline, 4, and 8 weeks]
3. Autism Spectrum Rating Scale [baseline, 4, and 8 weeks]
4. oxidative stress measures [baseline, 4, and 8 weeks]
