NCT00345800已完成1 期
Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
研究概览
简要总结
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Narcoleptic patients with cataplexy
排除标准
- •Subjects not diagnosed with narcolepsy with cataplexy
- •Exclusion Criteria:
研究组 & 干预措施
Sodium Oxybate
Experimental
- Active Substance: Sodium Oxybate
- Pharmaceutical form: Oral Solution
- Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
- Route of administration: Oral
干预措施: Sodium Oxybate (Xyrem) (Drug)
结局指标
主要结局
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
时间窗: After 1 month of treatment (Visit 3)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 3.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
时间窗: Baseline (Visit 2) - approximately 1 day
An assay of IGF-1 was done from blood sampled about 10 hours after bedtime on Visit 2.
The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
时间窗: After 3 months of treatment (Visit 4)
An assay of IGF-1 was done from blood sampled about 10 hours postdose on Visit 4.
次要结局
- The Osmolality Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3(Visit 3 (approximately 1 month))
- Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- Cortisol Measured at Visit 4(Visit 4 (approximately 3 months))
- The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Prolactin Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Prolactin Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study(Visit 1 through the end of the study (approximately 4 months))
- The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4(Visit 4 (approximately 3 months))
- Cortisol Measured at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- Cortisol Measured at Visit 3(Visit 3 (approximately 1 month))
- The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)(Baseline (Visit 2) - approximately 1 day)
- The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Osmolality Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study(Visit 1 through the end of the study (approximately 4 months))
- Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3(Visit 3 (approximately 1 month))
- Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4(Visit 4 (approximately 3 months))
- The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study(Visit 1 through the end of the study (approximately 4 months))
研究者
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