HealthyPhase 4NCT00532116
PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly
A Phase 4 study testing EMSAM (Selegiline Transdermal System) 6mg and EMSAM (Selegiline Transdermal System) 12mg in people with Healthy, run by Somerset Pharmaceuticals at 1 site in United States.
Trial summary
Evaluate the effect of age on the PK of two different doses of EMSAM. 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 and EMSAM (Selegiline Transdermal System) 12mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 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
- Male or Female, 18 to 45years of age (inclusive) and 65 years of age or older.
- Non-obese as defined by being within 15% of desirable body weight for frame size (Appendix II).
- In general good health as ascertained by physical examination (PE) including measurement of supine and standing vital signs, medical history, clinical laboratory studies, and 12-lead electrocardiogram (ECG).
- Females must have a negative serum pregnancy test during screening confirmed by a negative urine pregnancy screen at the baseline visit. Women of childbearing potential must agree to continuously use a medically acceptable method of birth control during the course of the study. Acceptable birth control methods are hormonal contraceptives, intrauterine devices or double barrier method (a combination of condom plus contraceptive foam). Postmenopausal females will be eligible to participate if their last normal menses was at least one (1) year prior to study entry.
- Able and willing to provide informed consent.
- Able and willing to follow a modified diet.
- Able and willing to follow the requirements of the study; willing to wear a patch, no swimming, no excessive exercise, etc.
Who cannot join
- Presence of significant acute or chronic medical disorder that might complicate or interfere with MAO inhibitor therapy, such as:
- Any cardiovascular or cardiac condition requiring drug treatment. Upon review with Sponsor, subjects with well controlled hypertension or hyperlipidemia will be allowed.
- History of symptomatic orthostatic hypotension, or in the investigator's best clinicaljudgment a clinically significant postural decrease in systolic blood pressure at screening or baseline.
- Type I diabetes mellitus, or poorly controlled Type II diabetes mellitus.
- Malignancy and/or chemotherapy within 1 year prior to screening, other than basal cell carcinoma. Malignancies more than 1 year may not preclude participation and will be reviewed on a case-by-case basis by the Somerset Pharmaceuticals, Inc., medical monitor.
- Any skin condition (e.g., eczema, psoriasis, dyshydrosis) that might interfere with application and adherence of the STS.
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- Known or suspected hypersensitivity to selegiline or other MAO inhibitors.
- Any significant immunological, pulmonary, hematologic, endocrine and/or metabolic disease or disorder or severe or acute medical illness, that is, metastatic cancer, brain tumors, decompensated cardiac, hepatic or renal failure.
- Neurological disorders including delirium, history of head trauma, movement disorders, dementia, multiple sclerosis, stroke, within the past 6 months preceding the study.
- Any central nervous system disorder including Alzheimer's disease, Parkinson's disease, epilepsy, or cerebrovascular disease.
- Any psychiatric disorders (except personality disorders).
- Any mood disorder including MDD which is current or relapsed over the past three years.
- ADHD.
- Any conditions that may cause depression including endocrinopathies other than diabetes, lymphoma, pancreatic cancer.
- Any other 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.
- Use of any medication listed below within five half-lives prior to baseline. A longer period of time may be specifically noted for certain medications as indicated:
- All contraindicated medications (see Section 7.1.4.3)
- Psychotropic medication, including centrally active anticholinergics, anticonvulsants, antiparkinsonian agents, fluoxetine (5 weeks), MAOIs (2 weeks), antipsychotics (oral - 60 days; intramuscular - 10 weeks), anxiolytics, vasodilators (exception: Viagra is permitted), cerebral enhancers (acetylcholinesterase inhibitors), psychostimulants, lithium carbonate, nootropics, reserpine, methyldopa (within 30 days), ergot preparations.
- Sympathomimetic drugs, e.g., amphetamines, methylphenidate, dopamine, epinephrine, norepinephrine, over-the-counter (OTC) and prescription nasal decongestants (with the exception of nasal steroids), oral or inhaled sympathomimetic bronchodilators (e.g., albuterol [Proventil], Serevent) and appetite suppressants.
- Any serotonergic drug including sumatriptan succinate (Imitrex), zolmitriptan (Zomig), cyproheptadine (Periactin), methysergide (Sansert) or other agonists or antagonists of serotonin receptors.
- Meperidine (Demerol), or other opioids.
- R(-)tryptophan, metoclopramide.
- St. John's wort / hypericum within two (2) weeks and other herbal supplements
- Dietary supplements containing tyramine and/or ephedrine.
- Presence of an Axis-II disorder that makes it unlikely that the subject will be compliant.
- Presence or history of bipolar disorder or psychotic disorder.
- Serious risk of suicide.
- History of substance abuse, including alcohol abuse as defined by DSM-IV criteria, within the past 12 months.
- Current use of tobacco products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Comparison of the 6mg/24hr and 12mg/24hr EMSAM (Selegiline Transdermal System) in Healthy Elderly and Non-Elderly Volunteers
Evaluate the effect of age on the PK of two different doses of EMSAM.
- Conditions
- Healthy
- Being tested
- EMSAM (Selegiline Transdermal System) 6mg, EMSAM (Selegiline Transdermal System) 12mg
- Keywords
- Healthy, 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) 6mgDrug
STS 6mg/24hr
EMSAM (Selegiline Transdermal System) 12mgDrug
EMSAm 12mg/24Hr
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | EMSAM 6mg Receives: Drug: EMSAM (Selegiline Transdermal System) 6mg |
| B | Active comparator | EMSAM (Selegiline Transdermal System) 12mg Receives: Drug: EMSAM (Selegiline Transdermal System) 12mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Proportionality of PK parameters and EMSAM release characteristics.
Measured: 33 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 completionAug 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
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somerset Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532116
- Sponsor's protocol ID
- S9303-P0601
- 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
- Pharmacokinetic Comparison of the 6mg/24hr and 12mg/24hr EMSAM (Selegiline Transdermal System) in Healthy Elderly and Non-Elderly Volunteers
- ClinicalTrials.gov ID
- NCT00532116
- Acronym / sponsor ID
- S9303-P0601
- Conditions
- Healthy
- Keywords
- Healthy, Elderly, Non Elderly, Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Somerset PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Aug 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.
Evaluate the effect of age on the PK of two different doses of EMSAM.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: EMSAM (Selegiline Transdermal System) 6mgEMSAM 6mg |
| B | Active comparator | Drug: EMSAM (Selegiline Transdermal System) 12mgEMSAM (Selegiline Transdermal System) 12mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female, 18 to 45years of age (inclusive) and 65 years of age or older.
- Non-obese as defined by being within 15% of desirable body weight for frame size (Appendix II).
- In general good health as ascertained by physical examination (PE) including measurement of supine and standing vital signs, medical history, clinical laboratory studies, and 12-lead electrocardiogram (ECG).
- Females must have a negative serum pregnancy test during screening confirmed by a negative urine pregnancy screen at the baseline visit. Women of childbearing potential must agree to continuously use a medically acceptable method of birth control during the course of the study. Acceptable birth control methods are hormonal contraceptives, intrauterine devices or double barrier method (a combination of condom plus contraceptive foam). Postmenopausal females will be eligible to participate if their last normal menses was at least one (1) year prior to study entry.
- Able and willing to provide informed consent.
Key exclusion criteria (29 listed)
- Presence of significant acute or chronic medical disorder that might complicate or interfere with MAO inhibitor therapy, such as:
- Any central nervous system disorder including Alzheimer's disease, Parkinson's disease, epilepsy, or cerebrovascular disease.
- Any psychiatric disorders (except personality disorders).
- Any mood disorder including MDD which is current or relapsed over the past three years.
- ADHD.
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) 6mgSTS 6mg/24hr | Drug | A |
| EMSAM (Selegiline Transdermal System) 12mgEMSAm 12mg/24Hr | Drug | B |
Primary outcome
Dose Proportionality of PK parameters and EMSAM release characteristics.
Time frame: 33 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and EMSAM (Selegiline Transdermal System) 12mg in people with Healthy, run by Somerset Pharmaceuticals at 1 site 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 29 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 1 site 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?
Dose Proportionality of PK parameters and EMSAM release characteristics. (time frame: 33 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.