HealthyPhase 3NCT00302393
Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
A Phase 3 study testing OROS methylphenidate hydrochloride and methylphenidate hydrochloride in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OROS methylphenidate hydrochloride and methylphenidate hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Feb 2008
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed written informed consent to participate in the study
- Age: 18 - 55
- If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative plasma pregnancy test
- Supine and standing blood pressure within the range 110/60 to 150/90 mmHg
- Heart rate, after resting for 5 minutes, within the range 46-90 beats/min
- Subjects who are within 20% of the ideal weight for height
- Right handed
Who cannot join
- Subjects with marked anxiety, tension, and agitation since the drug may aggravate these symptoms
- Subjects with known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
- Subjects with glaucoma
- Subjects with motor tics or with a family history or diagnosis of Tourette's syndrome
- Subjects treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
- Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.
Show all 20Show fewer
- Scores of Baseline Scales:
- Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale) (Hamilton 1960)
- Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale) (Beck et al 1961)
- Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
- Diagnosis of ADHD (attention deficit hyperactivity disorder)
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention
- Any clinically significant chronic medical condition, in the judgment of the investigator
- Mental impairment as evidenced by an intelligence quotient (I.Q.) < 75
- Exposure to dopamine receptor antagonists within the previous three (3) months
- Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan
- Subjects receiving psychotropic medication
- Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG (electrocardiogram), outside of normal limits
- Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant
- Subjects with a known recent history (within the past six [6] months) of illicit drug or alcohol dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy of Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the CNS DAT occupancy of the other two formulations will be intermediate.
The second aim of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release.
Read the detailed description
ROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. The main target of MPH in the brain is the dopamine transporter (DAT). We have an exquisitely sensitive methodology to measure DAT occupancy using C-11 Altropane and Positron Emission Tomography (PET). The time course of decay of the C-11 Altropane permits repeated imaging, thus allowing documentation of the pharmacokinetics of DAT receptor occupancy.
We will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; and OROS-MPH to OROS-MPH.
- Conditions
- Healthy
- Being tested
- OROS methylphenidate hydrochloride, methylphenidate hydrochloride
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS methylphenidate hydrochlorideDrug
Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours.
methylphenidate hydrochlorideDrug
Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| IR-MPH | Active comparator | Immediate Release Methylphenidate administered before PET Scan Receives: Drug: methylphenidate hydrochloride |
| Concerta | Active comparator | OROS Methylphenidate (Concerta) administered before PET Scan Receives: Drug: OROS methylphenidate hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The DAT receptor occupancy of OROS MPH and MPH IR using PET scanning with C-11 altropane. Objective measures also provided by d and l ritalinic acid and methylphenidate levels at pre-dose, hour 4, 5 and 6.
The first visit will consist of a baseline PET scan during which no medication will be administered. For the next four study visits, subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4. The study visits may be scheduled five to 30 days apart, but each subject must complete the five visits within a ten-week period.
Measured: Eligible subjects will be asked to return to the study center for five study visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionFeb 2008
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Responsible party
- Principal investigator, Thomas J. Spencer, MD, Massachusetts General Hospital
- Investigators
- Thomas Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302393
- Sponsor's protocol ID
- 2005-p-001811
- Status last verified
- Oct 2013
- First submitted
- 10 Mar 2006
- Last updated
- 22 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy of Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
- ClinicalTrials.gov ID
- NCT00302393
- Acronym / sponsor ID
- 2005-p-001811
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study start
- Jun 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Mar 2006 (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.
There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the CNS DAT occupancy of the other two formulations will be intermediate.
The second aim of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release.
Detailed description
ROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. The main target of MPH in the brain is the dopamine transporter (DAT). We have an exquisitely sensitive methodology to measure DAT occupancy using C-11 Altropane and Positron Emission Tomography (PET). The time course of decay of the C-11 Altropane permits repeated imaging, thus allowing documentation of the pharmacokinetics of DAT receptor occupancy.
We will test all combinations of initial administration and then delayed (repeated) administration of the two formulations: IR-MPH to IR-MPH; IR-MPH to OROS-MPH; OROS-MPH to IR-MPH; and OROS-MPH to OROS-MPH.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IR-MPH | Active comparator | Drug: methylphenidate hydrochlorideImmediate Release Methylphenidate administered before PET Scan |
| Concerta | Active comparator | Drug: OROS methylphenidate hydrochlorideOROS Methylphenidate (Concerta) administered before PET Scan |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed written informed consent to participate in the study
- Age: 18 - 55
- If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative plasma pregnancy test
- Supine and standing blood pressure within the range 110/60 to 150/90 mmHg
- Heart rate, after resting for 5 minutes, within the range 46-90 beats/min
Key exclusion criteria (20 listed)
- Subjects with marked anxiety, tension, and agitation since the drug may aggravate these symptoms
- Subjects with known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
- Subjects with glaucoma
- Subjects with motor tics or with a family history or diagnosis of Tourette's syndrome
- Subjects treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
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 |
|---|---|---|
| OROS methylphenidate hydrochlorideSubjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours. | Drug | Concerta |
| methylphenidate hydrochlorideSubjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours. | Drug | IR-MPH |
Primary outcome
The DAT receptor occupancy of OROS MPH and MPH IR using PET scanning with C-11 altropane. Objective measures also provided by d and l ritalinic acid and methylphenidate levels at pre-dose, hour 4, 5 and 6.
Time frame: Eligible subjects will be asked to return to the study center for five study visits.
The first visit will consist of a baseline PET scan during which no medication will be administered. For the next four study visits, subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4. The study visits may be scheduled five to 30 days apart, but each subject must complete the five visits within a ten-week period.
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 22 Oct 2013.
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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.
Thomas Spencer, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OROS methylphenidate hydrochloride and methylphenidate hydrochloride in people with Healthy, run by Massachusetts General Hospital 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 20 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 22 Oct 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The DAT receptor occupancy of OROS MPH and MPH IR using PET scanning with C-11 altropane. Objective measures also provided by d and l ritalinic acid and methylphenidate levels at pre-dose, hour 4, 5 and 6. (time frame: Eligible subjects will be asked to return to the study center for five study visits.). 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 22 Oct 2013.