NCT00499863
Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
See it on ClinicalTrials.gov ↗217 people
25.3%
74.7%
55 womenmiddle line = equal numbers162 men
- Phase
- PHASE3
- Paid for by
- Noven Therapeutics
- Finished
- 2008-05
- Health conditions
- ADHD
- Who could join
- Anyone
- Ages
- 13 Years – 17 Years
- Average age
- mean 14.6 years
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Not reported
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 17 Years.”
- No pregnant women
Women who were pregnant could not join.
“The female subject is pregnant or lactating.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“The female subject is pregnant or lactating.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“…tive serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.”
- No seizures
Women with epilepsy or past seizures were turned away.
“Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.”
- No cancer
Women with current or past cancer were turned away.
“Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. der…”
Study titles and rules are shown in their original English.