HealthyPhase 4NCT00531596
Evaluation of Adhesion and Dermal Tolerability of EMSAM
A Phase 4 study testing EMSAM (Selegiline Transdermal System) 6mg/24Hr, EMSAM (Selegiline Transdermal System) 9mg/24Hr and EMSAM (Selegiline Transdermal System) 12mg/24hr in people with Healthy, run by Somerset Pharmaceuticals at 2 sites in United States.
Trial summary
Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EMSAM (Selegiline Transdermal System) 6mg/24Hr, EMSAM (Selegiline Transdermal System) 9mg/24Hr and EMSAM (Selegiline Transdermal System) 12mg/24hr
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hill Top Research
Scottsdale, Arizona
Hill Top Research
St. Petersburg, Florida
About this study
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)
Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects.
Read the 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.
- Conditions
- Healthy
- Being tested
- EMSAM (Selegiline Transdermal System) 6mg/24Hr, EMSAM (Selegiline Transdermal System) 9mg/24Hr, EMSAM (Selegiline Transdermal System) 12mg/24hr
- Keywords
- Elderly, Non Elderly, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMSAM (Selegiline Transdermal System) 6mg/24HrDrug
EMSAM 6mg/24HR
EMSAM (Selegiline Transdermal System) 9mg/24HrDrug
EMSAM 9mg/24Hr
EMSAM (Selegiline Transdermal System) 12mg/24hrDrug
EMSAM 12mg/24Hr
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | EMSAM 6mg/24hr Receives: Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr |
| B | Active comparator | EMSAM 9mg/24Hr Receives: Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr |
| C | Active comparator | EMSAM 12mg/24Hr Receives: Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startApr 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somerset Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Melissa Goodhead, Study chair, Somerset Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531596
- Sponsor's protocol ID
- S9303-P0602
- Status last verified
- Sep 2007
- First submitted
- 18 Sep 2007
- Last updated
- 19 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00531596
- Acronym / sponsor ID
- S9303-P0602
- Conditions
- Healthy
- Keywords
- Elderly, Non Elderly, Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Somerset PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: EMSAM (Selegiline Transdermal System) 6mg/24HrEMSAM 6mg/24hr |
| B | Active comparator | Drug: EMSAM (Selegiline Transdermal System) 9mg/24HrEMSAM 9mg/24Hr |
| C | Active comparator | Drug: EMSAM (Selegiline Transdermal System) 12mg/24hrEMSAM 12mg/24Hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMSAM (Selegiline Transdermal System) 6mg/24HrEMSAM 6mg/24HR | Drug | A |
| EMSAM (Selegiline Transdermal System) 9mg/24HrEMSAM 9mg/24Hr | Drug | B |
| EMSAM (Selegiline Transdermal System) 12mg/24hrEMSAM 12mg/24Hr | Drug | C |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Goodhead study chair
Somerset Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMSAM (Selegiline Transdermal System) 6mg/24Hr, EMSAM (Selegiline Transdermal System) 9mg/24Hr and EMSAM (Selegiline Transdermal System) 12mg/24hr in people with Healthy, run by Somerset Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2007.