Evaluation of Adhesion and Dermal Tolerability of EMSAM

This study has been completed.
Sponsor:
Information provided by:
Somerset Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00531596
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A PHASE IV, OPEN-LABEL STUDY OF THE ADHESION AND DERMAL TOLERABILITY OF EMSAM (SELEGILINE TRANSDERMAL SYSTEM) IN HEALTHY ADULT SUBJECTS OF TWO AGE GROUPS (18 - 64 YEARS, AND 65 YEARS AND OLDER)

Resource links provided by NLM:


Further study details as provided by Somerset Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 21 Days ]

Enrollment: 300
Study Start Date: April 2007
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: A
EMSAM 6mg/24hr
Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr
EMSAM 6mg/24HR
Active Comparator: B
EMSAM 9mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr
EMSAM 9mg/24Hr
Active Comparator: C
EMSAM 12mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr
EMSAM 12mg/24Hr

Detailed Description:

The primary objectives of this study are to examine the 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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:

    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 years.
    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 applications.
    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531596

Locations
United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States
Sponsors and Collaborators
Somerset Pharmaceuticals
Investigators
Study Chair: Melissa Goodhead Somerset Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00531596     History of Changes
Other Study ID Numbers: S9303-P0602
Study First Received: September 18, 2007
Last Updated: September 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Somerset Pharmaceuticals:
Elderly
Non Elderly
Healthy Volunteers

Additional relevant MeSH terms:
Selegiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 26, 2014