Attention Deficit Disorder With HyperactivityPhase 3NCT00307684
Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing double blind PR OROS methylphenidate and open label PR OROS methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Janssen-Cilag International NV at 21 sites in 7 countries.
Trial summary
Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- double blind PR OROS methylphenidate and open label PR OROS methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has completed study CR002479 (42603ATT3002), according to protocol
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID)
- Healthy on the basis of physical examination, medical history
- Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
- Amendment (double-blind placebo-controlled period): written informed consent
- patient must have completed at least 52 weeks of open-label treatment and must have been on a stable daily dose of (PR) OROS methlyphenidate prior to inclusion to this phase
Who cannot join
- Patient is known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
- Allergy or hypersensitivty to methlyphenidate
- Any clinically unstable psychiatric condition including but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), Anti-social personality disorder, borderline personality disorder
- Use of other anti-depressants (unless patient has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue as long as dosage remains unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics, lithium)
- Any medication likely to interfere with safe administration of methylphenidate, or any conditions that are contraindicated for use of methlyphenidate
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Germany11 sites
Study site
Ahrensburg
Study site
Aschaffenburg
Study site
Berlin
Study site
Cologne
Study site
Essen
Study site
Freiburg I. Br.
Study site
Homburg
Study site
Mannheim
Study site
Ottobrunn bei München
Study site
Saarbrücken
Study site
Würzburg
About this study
Official title: An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.
Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.
Read the detailed description
This is an open label, multicentre extension study to trial 42603ATT3002. Patients, who were enrolled to trial 42603ATT3002 must have had a diagnosis of ADHD with some symptoms already present at the age of 7 and continuing in adulthood. The patients must have had at least mild to moderate symptoms of ADHD. In trial 42603ATT3002 the efficacy and safety of three fixed dosages of the study drug OROS methlyphenidate (MPH) was compared with placebo in adult subjects with ADHD in a double-blind phase. This double-blind phase was followed by an open-label phase, which was designed to assess the safety and tolerabiltiy of the study drug OROS methylphenidate in these subjects, when they got a dose, which was optimal to control their symptoms. In trial 42603ATT3004 patients are enrolled who completed the open-label phase of trial 42603ATT3002. Trial 42603ATT3004 is designed to assess the long-term safety and tolerabilty of OROS methylphenidate over a period of 52 weeks at a dose, which is optimal to control the symptoms. Patients may enter the extension study 42603ATT3004 at Visit 8 (End-of-Phase Visit, Open Label) of the 42603ATT3002 study as long as the patient has given informed consent prior to the visit being performed. Visit 8 data may then serve as baseline data for the extension study. These patients should continue treatment at the same optimal dosage of PR OROS methylphenidate as was attained during the open label phase of protocol 42603ATT3002. Patients who complete the 42603ATT3002 study, including post-study visit, may enter the extensions study up to 30 calendar days from the last dosing of open label trial medication of the 42603ATT3002 study. Patients should be titrated accordingly to their optimal dose attained in study 42603ATT3002. Patients will be assessed at regular intervals for at least 52 weeks.
Amendment: At completion of the open-label phase, patients can participate in a double-blind placebo-controlled phase, provided that they are giving written informed consent. At inclusion to the double-blind placebo-controlled phase, patients are assigned to one of two treatment arms by chance. One treatment arm will continue taking the same treatment at the same daily dose as during the open-label period. The other treatment arm will receive placebo treatment. As placebo, an inactive formulation or an empty treatment will be used. During the double-blind placebo-controlled phase, patients are asked to return to their doctor's office every other week. During these visits, physical examinations will be made, efficacy measures will be taken by means of questionnaires, that need to be completed either by the treating physician or the patient and any unwanted side effect will be recorded and treated if needed. One week after the end of the double-blind, placebo-controlled phase, patients have to return one more time to their doctor's office for the so called post-study visit, during which an additional physical examination will be performed and additional safety and efficacy parameters will be assessed.Patients will be assessed at regular intervals for at least 52 weeks. Daily oral dosages of 18, 36, 54, 72 and 90mg will be available and may be increased or decreased by 18mg increments based on clinical observations of response and tolerability for at least 52 weeks. Amendment: During the double-blind, placebo-controlled phase, patients will receive either active treatment at the previously assessed optimal dose or placebo tablets for a total of 4 weeks. Both treatments (active or placebo) are taken by mouth once per day in the morning.
- Being tested
- double blind placebo, double blind PR OROS methylphenidate, open label PR OROS methylphenidate
- Keywords
- Attention Deficit Hyperactivity Disorder, Adult, Long term safety, Efficacy, Quality of life
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double blind placeboDrug
matching placebo tablets once daily for 4 weeks
double blind PR OROS methylphenidateDrug
18, 36, 54,72 or 90 mg/day once daily for 4 weeks
open label PR OROS methylphenidateDrug
Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | open label PR OROS methylphenidate Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) Receives: Drug: open label PR OROS methylphenidate |
| 002 | Experimental | double blind PR OROS methylphenidate 18 36 54 72 or 90 mg/day once daily for 4 weeks Receives: Drug: double blind PR OROS methylphenidate |
| 003 | Placebo comparator | double blind placebo matching placebo tablets once daily for 4 weeks Receives: Drug: double blind placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)
Measured: Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks
Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint
To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.
CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54
Endpoint: last available post-baseline assessment.
Measured: DB baseline, DB endpoint
Secondary outcomes (5)
Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores
Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.
Subscale scores: best value: 0, worst value: 27
Measured: OL baseline, OL endpoint
Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint
Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7
Measured: OL baseline, OL endpoint
Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint
Quality of life measured by Q-LES-Q best score: 100 worst score: 0
Measured: OL baseline, OL endpoint
Change From DB Baseline to DB Endpoint in CGI-S Score
evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject's illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe).
Measured: DB baseline, DB endpoint
Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score
Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104
Measured: DB baseline, DB endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307684
- Sponsor's protocol ID
- CR011068
- Status last verified
- Apr 2014
- First submitted
- 24 Mar 2006
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.
PubMed 35201607Buitelaar JK, Trott GE, Hofecker M, Waechter S, Berwaerts J, Dejonkheere J, Schauble B. Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD. Int J Neuropsychopharmacol. 2012 Feb;15(1):1-13. doi: 10.1017/S1461145711001131. Epub 2011 Jul 29.
PubMed 21798108
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00307684
- Acronym / sponsor ID
- CR011068
- Keywords
- Attention Deficit Hyperactivity Disorder, Adult, Long term safety, Efficacy, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Posted 23 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time.
Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.
Detailed description
This is an open label, multicentre extension study to trial 42603ATT3002. Patients, who were enrolled to trial 42603ATT3002 must have had a diagnosis of ADHD with some symptoms already present at the age of 7 and continuing in adulthood. The patients must have had at least mild to moderate symptoms of ADHD. In trial 42603ATT3002 the efficacy and safety of three fixed dosages of the study drug OROS methlyphenidate (MPH) was compared with placebo in adult subjects with ADHD in a double-blind phase. This double-blind phase was followed by an open-label phase, which was designed to assess the safety and tolerabiltiy of the study drug OROS methylphenidate in these subjects, when they got a dose, which was optimal to control their symptoms. In trial 42603ATT3004 patients are enrolled who completed the open-label phase of trial 42603ATT3002. Trial 42603ATT3004 is designed to assess the long-term safety and tolerabilty of OROS methylphenidate over a period of 52 weeks at a dose, which is optimal to control the symptoms. Patients may enter the extension study 42603ATT3004 at Visit 8 (End-of-Phase Visit, Open Label) of the 42603ATT3002 study as long as the patient has given informed consent prior to the visit being performed. Visit 8 data may then serve as baseline data for the extension study. These patients should continue treatment at the same optimal dosage of PR OROS methylphenidate as was attained during the open label phase of protocol 42603ATT3002. Patients who complete the 42603ATT3002 study, including post-study visit, may enter the extensions study up to 30 calendar days from the last dosing of open label trial medication of the 42603ATT3002 study. Patients should be titrated accordingly to their optimal dose attained in study 42603ATT3002. Patients will be assessed at regular intervals for at least 52 weeks.
Amendment: At completion of the open-label phase, patients can participate in a double-blind placebo-controlled phase, provided that they are giving written informed consent. At inclusion to the double-blind placebo-controlled phase, patients are assigned to one of two treatment arms by chance. One treatment arm will continue taking the same treatment at the same daily dose as during the open-label period. The other treatment arm will receive placebo treatment. As placebo, an inactive formulation or an empty treatment will be used. During the double-blind placebo-controlled phase, patients are asked to return to their doctor's office every other week. During these visits, physical examinations will be made, efficacy measures will be taken by means of questionnaires, that need to be completed either by the treating physician or the patient and any unwanted side effect will be recorded and treated if needed. One week after the end of the double-blind, placebo-controlled phase, patients have to return one more time to their doctor's office for the so called post-study visit, during which an additional physical examination will be performed and additional safety and efficacy parameters will be assessed.Patients will be assessed at regular intervals for at least 52 weeks. Daily oral dosages of 18, 36, 54, 72 and 90mg will be available and may be increased or decreased by 18mg increments based on clinical observations of response and tolerability for at least 52 weeks. Amendment: During the double-blind, placebo-controlled phase, patients will receive either active treatment at the previously assessed optimal dose or placebo tablets for a total of 4 weeks. Both treatments (active or placebo) are taken by mouth once per day in the morning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: open label PR OROS methylphenidateopen label PR OROS methylphenidate Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) |
| 002 | Experimental | Drug: double blind PR OROS methylphenidatedouble blind PR OROS methylphenidate 18 36 54 72 or 90 mg/day once daily for 4 weeks |
| 003 | Placebo comparator | Drug: double blind placebodouble blind placebo matching placebo tablets once daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has completed study CR002479 (42603ATT3002), according to protocol
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID)
- Healthy on the basis of physical examination, medical history
- Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
- Amendment (double-blind placebo-controlled period): written informed consent
Key exclusion criteria (5 listed)
- Patient is known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
- Allergy or hypersensitivty to methlyphenidate
- Any clinically unstable psychiatric condition including but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), Anti-social personality disorder, borderline personality disorder
- Use of other anti-depressants (unless patient has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue as long as dosage remains unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics, lithium)
- Any medication likely to interfere with safe administration of methylphenidate, or any conditions that are contraindicated for use of methlyphenidate
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 |
|---|---|---|
| double blind placebomatching placebo tablets once daily for 4 weeks | Drug | 003 |
| double blind PR OROS methylphenidate18, 36, 54,72 or 90 mg/day once daily for 4 weeks | Drug | 002 |
| open label PR OROS methylphenidateFlexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) | Drug | 001 |
Primary outcome
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks
To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)
Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint
Time frame: DB baseline, DB endpoint
To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS. CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54 Endpoint: last available post-baseline assessment.
5 secondary outcomes
Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores
Time frame: OL baseline, OL endpoint
Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint
Time frame: OL baseline, OL endpoint
Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint
Time frame: OL baseline, OL endpoint
Change From DB Baseline to DB Endpoint in CGI-S Score
Time frame: DB baseline, DB endpoint
Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score
Time frame: DB baseline, DB endpoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35201607Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.
- Derived from this study: PubMed 21798108Buitelaar JK, Trott GE, Hofecker M, Waechter S, Berwaerts J, Dejonkheere J, Schauble B. Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD. Int J Neuropsychopharmacol. 2012 Feb;15(1):1-13. doi: 10.1017/S1461145711001131. Epub 2011 Jul 29.
- An Open-Label, Multicentre Study to Evaluate the Long-Term Safety of Prolonged Release (PR) OROS Methylphenidate (18, 36, 54, 72 and 90 mg/day) in Adults with Attention Deficit/Hyperactivity DisorderLink provided by the sponsor.
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing double blind PR OROS methylphenidate and open label PR OROS methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by Janssen-Cilag International NV at 21 sites in 7 countries.
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 6 inclusion and 5 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Netherlands, Norway, Portugal, Switzerland and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00307684, which also lists 2 linked publications.
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 21 Apr 2014.