AdhdNCT05410626
The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original
A study testing prolong-release methylphenidate in people with Adhd, run by Mahidol University.
Trial summary
This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Adhd
- What is being tested?
- prolong-release methylphenidate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Aug 2022
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 6 to 12 years
- Diagnosis of ADHD according to DSM-5 of ICD-10
- Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
- Patient who has a stable clinical symptoms.
- Patients or their legal representatives provide informed consent prior to enrollment
Who cannot join
- Patients who present of a serious obstructive gastrointestinal disease
- Patients cannot swallow the whole tablet
- Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
- Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
- Patients or patients' family have a history of poor compliance
- Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days
- Patients who receiving PR-MPH except stop taking more than 7 days
- Patients' parent has a family problem and currently treatment with family therapy or adjust medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders
This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment
Read the detailed description
This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.
- Conditions
- Adhd
- Being tested
- prolong-release methylphenidate
- 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.
prolong-release methylphenidateDrug
Also called Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidate
This randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV.
| Study group | Role | What they receive |
|---|---|---|
| original | Experimental | This study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. Receives: Drug: prolong-release methylphenidate |
| generic | Active comparator | This study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. Receives: Drug: prolong-release methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms
Measured: baseline, 4 and 8 week
Secondary outcomes (3)
The change from baseline in Clinical Global Impression-Severity (CGI-S) scale
CGI-S scale is measured the severity of symptoms by physician, rated from 1 (normal) to 7 (among the most severely ill patients)
Measured: baseline, 4 and 8 week
The difference in discontinuation rate between two groups of treatment
Discontinuation rate is a proportion of patients who discontinue medication from any reason
Measured: 4 and 8 week
The difference in adverse events rate between two groups of treatment
adverse events rate is a proportion of patients who have the adverse events
Measured: baseline, 4 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhdStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanatthida Muangkum, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410626
- Sponsor's protocol ID
- COA.MU-DT/PY-IRB 2021/033.3003
- Other IDs
- STY.COA004/2564
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders
- ClinicalTrials.gov ID
- NCT05410626
- Acronym / sponsor ID
- COA.MU-DT/PY-IRB 2021/033.3003
- Conditions
- Adhd
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Jun 2022 (actual)
- 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.
This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment
Detailed description
This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| original | Experimental | Drug: prolong-release methylphenidateThis study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. |
| generic | Active comparator | Drug: prolong-release methylphenidateThis study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages 6 to 12 years
- Diagnosis of ADHD according to DSM-5 of ICD-10
- Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
- Patient who has a stable clinical symptoms.
- Patients or their legal representatives provide informed consent prior to enrollment
Key exclusion criteria (8 listed)
- Patients who present of a serious obstructive gastrointestinal disease
- Patients cannot swallow the whole tablet
- Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
- Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
- Patients or patients' family have a history of poor compliance
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 |
|---|---|---|
| prolong-release methylphenidateAlso: Osmotic-controlled release oral delivery system(OROS) methylphenidate, Osmotic-controlled release methylphenidateThis randomization, cross-over design study will enroll subjects who receive a stable dose of immediate-release methylphenidate (IR-MPH) for at least 4 weeks. Eligible subjects will be switching from IR-MPH to the first brand prolong-release methylphenidate (PR-MPH) for 4 weeks and switching to another brand for 4 weeks. The study consists of 3 parts: screening, study period, and post-treatment follow-up. The duration of this study will be 8 weeks with 2 visits during the study period. The primary outcome is the efficacy of treatment will be evaluated by SNAP-IV. | Drug | generic, original |
Primary outcome
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
Time frame: baseline, 4 and 8 week
SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms
3 secondary outcomes
The change from baseline in Clinical Global Impression-Severity (CGI-S) scale
Time frame: baseline, 4 and 8 week
The difference in discontinuation rate between two groups of treatment
Time frame: 4 and 8 week
The difference in adverse events rate between two groups of treatment
Time frame: baseline, 4 and 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Chanatthida Muangkum principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing prolong-release methylphenidate in people with Adhd, run by Mahidol University.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chanatthida Muangkum (6654419935, chanatt.mua@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score (time frame: baseline, 4 and 8 week). 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 8 Jun 2022.