Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly
and non-elderly subjects.
tolerability (irritation) of EMSAM in two populations consisting of non-elderly (18 - 64
years) and elderly (65 years and older) healthy volunteers. EMSAM will be dosed over the
range of proposed sizes for marketing [(6mg/24hr), (9mg/24hr), and (12mg/24hr)]. Adhesion
and tolerability (irritation) will be examined at three different application site areas
(upper torso [includes chest and back], upper arm, and upper thigh).
The secondary objective is to examine if the adhesion characteristics and dermal tolerability
(irritation) of EMSAM may be influenced by the secondary factors such as gender, race,
physical activity, and bathing/showering practices.
Minimum age: 18 Years.
Maximum age: N/A.
To be eligible for study participation, subjects will meet the following criteria:
- Able and willing to provide written informed consent.
- Able and willing to follow a modified diet.
- 18 years of age and older.
- Male or female.
- If female and of childbearing potential, subject must have a negative pregnancy screen
at baseline and may not be lactating. Females of childbearing potential must
demonstrate use of an acceptable form of birth control, such as hormonal
contraceptive, intrauterine device or barrier method (i. e. condom w/spermicide).
NOTE: Abstinence and partner vasectomy are not acceptable methods of contraception.
- In general good health as ascertained by physical examination, supine and standing
vital signs, laboratory test results, 12 lead ECG and medical history.
Any of the following conditions will exclude subjects from eligibility for study
- Subjects with a past or present condition that includes any of the following:
1. In the opinion of the Investigator, any significant cardiovascular disease or
disorder including myocardial infarction, cardiac arrhythmia, hypertension or
recurrent episodes of orthostatic hypotension.
2. Any skin abnormalities at or near designated patch application sites that might
interfere with the conduct or interpretation of the study including the presence
of moles, blemishes, excess hair, scars, tattoos, sunburn or other marks on the
application sites that may obscure grading of the site(s).
3. Any known hypersensitivity, or related hypersensitivity, to selegiline or to skin
adhesives (i. e. surgical tape, etc.).
4. Any significant immunological, pulmonary, hematologic, endocrine and/or metabolic
disease or disorder or severe or acute medical illness, such as, metastatic
cancer, brain tumors, decompensated cardiac, hepatic or renal failure.
5. Neurological disorders including delirium, history of significant head trauma,
movement disorders, dementia, multiple sclerosis or stroke.
6. Any psychiatric disorders (except personality disorders) requiring treatment or
therapy within the last three months.
7. Any mood disorder including MDD which is current or relapsed over the past three
8. Attention deficit hyperactivity disorder or attention deficit disorder.
9. Any other condition, illness or disorder that in the opinion of the Investigator
would place the subject at significant risk or any inability to follow the
requirements of the study regarding maintaining scheduled visits or patch
10. Known substance abuse or addiction.
11. Any significant allergy, especially involving dermal manifestations.
12. History of sun hypersensitivity and photosensitive dermatoses.
- Recent or current treatment with systemic or topical drugs or medications which can
interfere with skin responses (i. e. steroids, corticosteroids, antihistamines or
anti-inflammatory agents). Daily regimens of low-dose aspirin is acceptable.
- Current or anticipated use of meperidine, tricyclic antidepressants, or selective
serotonin reuptake inhibitors (i. e., fluoxetine [Prozac], etc) and other
antidepressant medications (e. g., SNRI's, MAOI's, buproprion, etc).
- Use of any herbal or homeopathic remedies (excluding vitamins, fish oil, echinacea,
glucosamine, chondroitin or calcium)within 14 days of study drug administration,
during study conduct and 14 days after the completion of the study medication.
- Participation in a clinical investigation within 28 days prior to baseline.
- Current use of any agents listed as contraindicated (Section 10. 3.1. 3) or as listed in
the approved label