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| Sponsor: | Somerset Pharmaceuticals |
|---|---|
| Information provided by: | Somerset Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00531596 |
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 IV |
| 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) |
| 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
|
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 |
Inclusion Criteria:
To be eligible for study participation, subjects will meet the following criteria:
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:
Contacts and Locations| United States, Arizona | |
| Hill Top Research | |
| Scottsdale, Arizona, United States | |
| United States, Florida | |
| Hill Top Research | |
| St. Petersburg, Florida, United States | |
| Study Chair: | Melissa Goodhead | Somerset Pharmaceuticals |
More Information
| 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 |
|
Elderly Non Elderly Healthy Volunteers |
|
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 |