NCT01463098
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
See it on ClinicalTrials.gov ↗122 people
48.4%
51.6%
59 womenmiddle line = equal numbers63 men
- Phase
- PHASE1
- Paid for by
- Eisai Inc.
- Finished
- 2012-08-11
- Health conditions
- Insomnia
- Who could join
- Anyone
- Ages
- 18 Years – 64 Years
- Average age
- Not reported
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 50.8% · Black / African American 41% · Not reported 3.3% · Asian 2.5% · American Indian / Alaska Native 1.6% · Native Hawaiian / Pacific Islander 0.8% · More than one race 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 64 Years.”
- No women who could get pregnant
Most women roughly 15–50 years old were turned away.
“All females must be of non-childbearing potential”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“With a known history of significant neurological or serious psychiatric illness”
Study titles and rules are shown in their original English.