Evaluation of Adhesion and Dermal Tolerability of EMSAM

NCT00531596 | Completed Phase 4

• 1 other identifier: S9303-P0602
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects.

Conditions

Healthy

Keywords

Elderly; Non Elderly; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Adhesion characteristics and dermal tolerability (irritation) of EMSAM in two populations consisting of non-elderly (18 - 64 years) and elderly (65 years and older) healthy volunteers.

  21 Days

Study Arms (3)

A

ACTIVE COMPARATOR

EMSAM 6mg/24hr

Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr

B

ACTIVE COMPARATOR

EMSAM 9mg/24Hr

Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr

C

ACTIVE COMPARATOR

EMSAM 12mg/24Hr

Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr

Interventions

EMSAM (Selegiline Transdermal System) 6mg/24Hr DRUG

EMSAM 6mg/24HR

A

EMSAM (Selegiline Transdermal System) 9mg/24Hr DRUG

EMSAM 9mg/24Hr

B

EMSAM (Selegiline Transdermal System) 12mg/24hr DRUG

EMSAM 12mg/24Hr

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Any of the following conditions will exclude subjects from eligibility for study participation:
• Subjects with a past or present condition that includes any of the following:
• In the opinion of the Investigator, any significant cardiovascular disease or disorder including myocardial infarction, cardiac arrhythmia, hypertension or recurrent episodes of orthostatic hypotension.
• 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).
• Any known hypersensitivity, or related hypersensitivity, to selegiline or to skin adhesives (i.e. surgical tape, etc.).
• 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.
• Neurological disorders including delirium, history of significant head trauma, movement disorders, dementia, multiple sclerosis or stroke.
• Any psychiatric disorders (except personality disorders) requiring treatment or therapy within the last three months.
• Any mood disorder including MDD which is current or relapsed over the past three years.
• Attention deficit hyperactivity disorder or attention deficit disorder.
• 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 applications.
• Known substance abuse or addiction.
• Any significant allergy, especially involving dermal manifestations.
• 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.

Sponsors & Collaborators

• Somerset Pharmaceuticals: lead

Study Sites (2)

Hill Top Research

Scottsdale, Arizona, United States

Location

Hill Top Research

St. Petersburg, Florida, United States

Location

MeSH Terms

Interventions

Selegiline

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Melissa Goodhead

  Somerset Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: April 1, 2007
• Study Completion: July 1, 2007
• Last Updated: September 19, 2007

Record last verified: 2007-09

Locations

US (2)