Treatment Resistant Epilepsy and N-Acetyl Cysteine
Słowa kluczowe
Abstrakcyjny
Opis
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
Daktyle
| Ostatnia weryfikacja: | 09/30/2015 |
| Pierwsze przesłane: | 02/02/2014 |
| Szacowana liczba przesłanych rejestracji: | 02/02/2014 |
| Wysłany pierwszy: | 02/03/2014 |
| Ostatnia aktualizacja przesłana: | 10/06/2015 |
| Ostatnia opublikowana aktualizacja: | 10/08/2015 |
| Rzeczywista data rozpoczęcia badania: | 03/31/2013 |
| Szacowana data zakończenia podstawowej działalności: | 12/31/2014 |
| Szacowana data zakończenia badania: | 12/31/2014 |
Stan lub choroba
Interwencja / leczenie
Drug: N-Acetyl Cysteine (NAC)
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| 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. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 6 Years Do 6 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | 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. |
Wynik
Podstawowe miary wyników
1. Recruitment rate [1 year]
Miary wyników wtórnych
1. seizure frequency [up to 8 weeks]
Inne miary wyników
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]
