Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 4NCT00776009

Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

A Phase 4 study testing Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Novartis Pharmaceuticals at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Attention-Deficit/Hyperactivity Disorder (ADHD)
What is being tested?: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 8 sitesUnited States
Study dates: Oct 2008to Dec 2008
Phase: Phase 4
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 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female subjects aged 6-12 years, inclusive.
Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.

Who cannot join

Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
Diagnosed with or history of a tic disorder or Tourette's syndrome.
History of seizure disorder.
The presence of a known medical condition that would preclude the use of methylphenidate.
A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.
ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) at Screening.

Show all 13Show fewer

A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
Subjects who have participated in an investigational trial within the past 4 weeks (28 days)
Subjects who are currently taking antidepressants or other psychotropic medication.
Subjects who have initiated psychotherapy during the three months prior to randomization.
Subjects with a positive urine drug screen.
Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Bayou City Research
Houston, Texas, 77007
Claghorn-Lesem Research Clinic
Houston, Texas, 77008
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Clinical Study Center, LLC
Little Rock, Arkansas, 72205
Behavioral Neurology
Lubbock, Texas, 79423
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Being tested: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR), Placebo
Keywords: ADHD, children, subjects, laboratory classroom
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.

Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)Drug
10 mg and/or 20 mg capsules
PlaceboDrug
Placebo Comparator

Study groups in NCT00776009
Study group	Role	What they receive
Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg	Experimental	Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. Receives: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg	Active comparator	Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. Receives: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
Placebo	Placebo comparator	Two Capsules taken orally once a day for 7 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose
SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.
Measured: Pre-dose to 10, 11, and 12 hours post-dose

Secondary outcomes (4)

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose
SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
Measured: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose
SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
Measured: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose
Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to "academic productivity." A positive score indicates improvement.
Measured: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose
Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to "academic productivity." A positive score indicates improvement.
Measured: Pre-dose to 10, 11, and 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Dec 2008

First posted20 Oct 2008 (estimated)
Study startOct 2008
Primary completionDec 2008
Study completionDec 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 (1)Papers the sponsor has linked to this study.
Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00776009
Sponsor's protocol ID: CRIT124EUS21
Status last verified: Jun 2011
First submitted: 16 Oct 2008
Last updated: 8 Jun 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Brams M, Turnbow J, Pestreich L, Giblin J, Childress A, McCague K, Muniz R. A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate extended-release in children with attention-deficit/hyperactivity disorder: late-day symptom control. J Clin Psychopharmacol. 2012 Oct;32(5):637-44. doi: 10.1097/JCP.0b013e3182677825.
PubMed 22926597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Cross-over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.
ClinicalTrials.gov ID: NCT00776009
Acronym / sponsor ID: CRIT124EUS21
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD, children, subjects, laboratory classroom
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 20 Oct 2008 (estimated)
Results: Posted 16 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg	Experimental	Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days.
Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg	Active comparator	Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days.
Placebo	Placebo comparator	Drug: PlaceboTwo Capsules taken orally once a day for 7 days

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male and female subjects aged 6-12 years, inclusive.
Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.

Key exclusion criteria (13 listed)

Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
Diagnosed with or history of a tic disorder or Tourette's syndrome.
History of seizure disorder.
The presence of a known medical condition that would preclude the use of methylphenidate.
A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.

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
Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)10 mg and/or 20 mg capsules	Drug	Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg, Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg
PlaceboPlacebo Comparator	Drug	Placebo

Primary outcome

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose
Time frame: Pre-dose to 10, 11, and 12 hours post-dose
SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.

4 secondary outcomes

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose
Time frame: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose
Time frame: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose
Time frame: Pre-dose to 10, 11, and 12 hours post-dose
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose
Time frame: Pre-dose to 10, 11, and 12 hours post-dose

Results and safety

Results posted to the registry on 16 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo	26	26
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg	28	27
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo	29	28
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg	27	27
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg	28	26
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg	27	27

Primary outcome: Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose

Time frame: Pre-dose to 10, 11, and 12 hours post-dose. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg n = 159	Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg n = 158	Placebo n = 158
Value	-2.02 (0.717)	-4.47 (0.724)	4.50 (.723)

Population analysed: Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg	0 of 165 (0%)	10 of 165 (6.1%)	Not reported
Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg	1 of 165 (0.6%)	8 of 165 (4.8%)	Not reported
Placebo	0 of 165 (0%)	0 of 165 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22926597Brams M, Turnbow J, Pestreich L, Giblin J, Childress A, McCague K, Muniz R. A randomized, double-blind study of 30 versus 20 mg dexmethylphenidate extended-release in children with attention-deficit/hyperactivity disorder: late-day symptom control. J Clin Psychopharmacol. 2012 Oct;32(5):637-44. doi: 10.1097/JCP.0b013e3182677825.

Related trials for Attention-Deficit/Hyperactivity Disorder (ADHD)

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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.

Novartis Pharmaceuticals study director

Novartis

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 13 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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. 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 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?

Yes. Results are posted in the registry (first posted 16 Mar 2011). 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?

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose (time frame: Pre-dose to 10, 11, and 12 hours post-dose). 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 NCT00776009, which also lists 1 linked publication.

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 2011.