Clinical trials on stavzor
Stavzor is a drug that has been approved for commercial release by the Food and Drug Administration (FDA) in July of 2008. This drug is a form of valproic acid, an enteric drug that is employed for the treatment of convulsions. Stavzor is supplied in the format of a soft gel capsule, with an enteric coating that works as a barrier and prevents the medication from being absorbed until it reaches the small intestine. Therefore, Stavzor is a delayed-release medication that is used to treat bipolar mania, seizures and migraine headaches.
Mania Clinical Results The clinical trial conducted by Bazzinet et al. (2006) tested Stavzor over a twenty-one day period. Adults were given 250 mg of valproate twice a day, wherein this dosage that was pre-adjusted in order for the subjects to achieve serum concentrations of valproate between 50 to 100 mcg/ml by the seventh day. Assessments were conducted using the Young Mania Rating Scale which is a Brief Psychiatric Rating Scale. The Global Assessment scale was also employed in this study.
The results showed that sixty percent of the subjects experienced a thirty percent decline in their symptom score and the subjects that took a placebo experienced only a twenty-six percent decline. Another clinical trial led by Shinohara and colleagues (2007) was also conducted over a twenty-one day period. This study consisted of subjects categorized into three groups, the valproate group (case), the placebo group (control) and the lithium group (out-group). The dosage administered was 250 mg twice a day, pre-adjusted to a range of 750-2500 mcg/ml a day and concentrated serum valproate was given in dosages of 40-150 mcg/ml.
The lithium group experienced a gradual increase in dosages. By day seven the dosage was 1312 mg per day, 1869 mg per day by day fourteen and 1984 mg per day by day twenty-one. Assessments were done using the Manic Rating Scale and two subscales. The total score of all three rating scales showed that there was a thirty percent decline in their symptom score. There was only a twenty-nine percent decline in the members the placebo group.
Epilepsy Clinical Results The first clinical trial on Stavzor in relation to epilepsy was conducted by Jedrzejczak et al. , (2008), consisting of 144 subjects who suffered at least eight and sometimes more seizures per day over a period of eight weeks. Doses of either carbamazepine or phenytoin were given as monotherapy. In addition to their original antiepilepsy drugs, either valproate or a placebo was randomly given. The study took place over sixteen weeks. The subjects who took valproate experienced the greatest reduction in seizures. In the study led by Deleu et al. (2007), volproate was the sole anti-seizure drug.
Over an eight to twelve week period, the subjects transitioned from their anti-seizure medication to valproate. Valproate was given in high and low dosages. The subjects were observed for up to twenty-two weeks. Although there was a decline in seizures for both the high dose and low dose participants, high dose participants experienced the greatest decline. Migraine Clinical Results Participants in the independent studies of Kinze et al. , (2001) and Yurekli et al. (2007) had a history of experiencing at least two migraine headaches a month.
The studies consisted of a four-week baseline period during which time the subjects were given a placebo. This was followed by twelve-week treatment period during which the subjects were given either valproate or a placebo. Four of the twelve weeks were a dose titration period and eight of the twelve weeks were a maintenance period. The Kinze (2001) study consisted of 107 participants. Ninety of them took part in the eight week maintenance period. Daily doses ranged from 500 to 2500 mg. a day with dosages over 500 mg. were divided equally and given three times a day.
The subjects in the valproate group had a fewer occurrences of migraines than those in the placebo group. The Yurekli (2008) study consisted of 176 participants with 137 of them having taken part in the eight week maintenance period. Participants were given dosages of either 500, 1000 or 1500 mg. per day or a placebo. The dosages were divided and given twice a day. The valproate was gradually increased from 250 mg. to reach one of the three dosages. The subjects in the valproate group experienced fewer migraines in all three dosage groups than the subjects taking the placebo.
Side Effects of Stavzor Some of the side effects that may occur when taking Stavzor include nausea, dizziness, vomiting, abdominal pain, rash, diarrhea, increased appetite, tremors or weight gain. The more serious side effects include liver problems, birth defects if taken during pregnancy or pancreatitis. References Bazinet RP, Weis MT, Rapoport SI, Rosenberger TA (2006): Valproic acid selectively inhibits conversion of arachidonic acid to arachidonoyl-CoA by brain microsomal long-chain fatty acyl-CoA synthetases: Relevance to bipolar disorder.
Psychopharmacology, 184(1):122-9. Deleu D, Al-Hail H, Mesraoua B, Mahmoud HA, Gulf Vipe Study Group (2007): Short-term efficacy and safety of valproate sustained-release formulation in newly diagnosed partial epilepsy VIPe-study: A multicenter observational open-label study. Saudi Medical Journal, 28(9):1402-7 Jedrzejczak J, Kuncikova M, Magureanu S; VIPe Study Group (2008): An observational study of first-line valproate monotherapy in focal epilepsy. European Journal of Neurology, 15(1):66-72.
Kinze S, Clauss M, Reuter U, Wolf T, Dreier JP, Einhaupl KM, Arnold G (2001): Valproic acid is effective in migraine prophylaxis at low serum levels: A prospective open-label study. Headache, 41(8):774-8. Shinohara K, Okamoto Y, Jitsuiki H, Yamashita H, Morinobu S, Yamayaki S (2007): The tolerability of oral-loaded valproate after remission of acute mania in Japanese patients with bipolar disorder. Journal of Clinical Psychiatry, 9(3):241. Yurekli VA, Akhan G, Kutluhan S, Uzar E, Koyuncuoglu HR, Gultekin F (2007): The effect of sodium valproate on chronic daily headache and its subgroups. Journal of Headache and Pain, 9(1):37-41.
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