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Attention Deficit/Hyperactivity DisorderPhase 3NCT01338818

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

A Phase 3 study testing Ritalin LA (methylphenidate hydrochloride extended release) in people with Attention Deficit/Hyperactivity Disorder, run by Novartis Pharmaceuticals at 48 sites in 6 countries.

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 long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Attention Deficit/Hyperactivity Disorder
What is being tested?
Ritalin LA (methylphenidate hydrochloride extended release)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
299 participants
Where
48 sitesin 6 countries
Study dates
Apr 2011to Feb 2013
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)

Who cannot join

  • Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
  • Patients who during the core study developed cardiovascular disorders.
  • Pregnant women.
  • Patients who developed seizures during the core study.
  • Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
  • Diagnosis or family history of Tourette's syndrome.
  • Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

48 sites in 6 countries.

48 sites in 6 countries

Germany22 sites

  • Novartis Investigative Site

    Bamberg, Germany, 96047

  • Novartis Investigative Site

    Berlin, Germany, 12203

  • Novartis Investigative Site

    Berlin, 10629

  • Novartis Investigative Site

    Dresden, 01129

  • Novartis Investigative Site

    Freiburg im Breisgau, 79104

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Hamburg, Germany, 20259

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Landau, 76829

  • Novartis Investigative Site

    Leipzig, 04157

  • Novartis Investigative Site

    Limburg, 65549

  • Novartis Investigative Site

    Ludwigsburg, Germany, 71636

  • Novartis Investigative Site

    Mainz, Germany, 55131

  • Novartis Investigative Site

    Mannheim, 68159

  • Novartis Investigative Site

    München, Germany, 80333

  • Novartis Investigative Site

    Naumburg, Germany, 06618

  • Novartis Investigative Site

    Nuremberg, Germany, 90419

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Westerstede/Oldenburg, 26655

  • Novartis Investigative Site

    Wolfsburg, Germany, 38444

  • Novartis Investigative Site

    Würzburg, 97070

Other trials in Germany

United States16 sites

  • Novartis Investigative Site

    Bellevue, Washington, 98004

  • Novartis Investigative Site

    Beverly Hills, California, 90210

  • Novartis Investigative Site

    Bradenton, Florida, 34208

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Fargo, North Dakota, 58103

  • Novartis Investigative Site

    Houston, Texas, 77007

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigative Site

    Las Vegas, Nevada, 89128

  • Novartis Investigative Site

    Libertyville, Illinois, 60048

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Owensboro, Kentucky, 42301

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19149

  • Novartis Investigative Site

    Seattle, Washington, 98104

  • Novartis Investigative Site

    Spring Valley, California, 91978-1522

  • Novartis Investigative Site

    West Plam Beach, Florida, 33407

Other trials in United States

Belgium5 sites

  • Novartis Investigative Site

    Bruges, Belgium, 8310

  • Novartis Investigative Site

    Heusden-Zolder, Belgium, 3550

  • Novartis Investigative Site

    Kessel-Lo, 3010

  • Novartis Investigative Site

    Mechelen, 2800

  • Novartis Investigative Site

    Uccle, Belgium, 1180

Other trials in Belgium

Colombia2 sites

  • Novartis Investigative Site

    Antioquia

  • Novartis Investigative Site

    Santa Fe de Antioquia, Antioquia, 0000

Other trials in Colombia

Sweden2 sites

  • Novartis Investigative Site

    Luleå, 972 35

  • Novartis Investigative Site

    Malmö, 211 53

Other trials in Sweden

Denmark1 site

  • Novartis Investigative Site

    Århus C, 8000

Other trials in Denmark

About this study

Official title: A 6-month, Open-label Extension to a 40-week, Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in the Treatment of Adult Patients With Childhood-onset ADHD

This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Being tested
Ritalin LA (methylphenidate hydrochloride extended release)
Keywords
Attention Deficit /Hyperactivity Disorder,, hyperactivity
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ritalin LA (methylphenidate hydrochloride extended release)Drug

    Also called Ritalin LA, methylphenidate hydrochloride extended release, RIT124D

    Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.

Study groups in NCT01338818
Study groupRoleWhat they receive
Ritalin LAExperimentalAll participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day).
Receives: Drug: Ritalin LA (methylphenidate hydrochloride extended release)

What is being measured

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

  1. Number of Participants With Adverse Events, Serious Adverse Events and Deaths.

    Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.

    Measured: Week 40 - Week 66

Secondary outcomes (2)

  1. Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.

    Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing.

    Measured: week 40 - week 66

  2. Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score

    SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.

    Measured: week 40 - week 66

Timeline

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

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338818
Sponsor's protocol ID
CRIT124D2302E1
Other IDs
2011-000210-19
Status last verified
Nov 2014
First submitted
15 Apr 2011
Last updated
24 Nov 2014

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 35201607

  • Ginsberg Y, Arngrim T, Philipsen A, Gandhi P, Chen CW, Kumar V, Huss M. Long-term (1 year) safety and efficacy of methylphenidate modified-release long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity disorder: a 26-week, flexible-dose, open-label extension to a 40-week, double-blind, randomised, placebo-controlled core study. CNS Drugs. 2014 Oct;28(10):951-62. doi: 10.1007/s40263-014-0180-4.

    PubMed 25183661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ritalin LA (methylphenidate hydrochloride extended release) in people with Attention Deficit/Hyperactivity Disorder, run by Novartis Pharmaceuticals at 48 sites in 6 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 1 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: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany, United States, Belgium, Colombia, Sweden and 1 more country. 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?

Yes. Results are posted in the registry (first posted 26 May 2014). 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?

Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (time frame: Week 40 - Week 66). 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 NCT01338818, 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 24 Nov 2014.

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