Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00307684 | Completed Phase 3 Results

• 1 other identifier: CR011068
• Study Type: interventional
• Target: 155
• Locations: 7 countries
• Sites: 21

Brief 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). 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; Adult; Long term safety; Efficacy; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  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

  OL baseline, OL endpoint

• Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint

  OL baseline, OL endpoint

• Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint

  OL baseline, OL endpoint

• Change From DB Baseline to DB Endpoint in CGI-S Score

  DB baseline, DB endpoint

• Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score

  DB baseline, DB endpoint

Study Arms (3)

001

EXPERIMENTAL

open label PR OROS methylphenidate Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)

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

Drug: double blind PR OROS methylphenidate

003

PLACEBO COMPARATOR

double blind placebo matching placebo tablets once daily for 4 weeks

Drug: double blind placebo

Interventions

double blind placebo DRUG

matching placebo tablets once daily for 4 weeks

003

double blind PR OROS methylphenidate DRUG

18, 36, 54,72 or 90 mg/day once daily for 4 weeks

002

open label PR OROS methylphenidate DRUG

Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (21)

Unknown Facility

Paris, France

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Ahrensburg, Germany

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Aschaffenburg, Germany

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Berlin, Germany

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Cologne, Germany

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Essen, Germany

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Freiburg I. Br., Germany

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Homburg, Germany

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Mannheim, Germany

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Ottobrunn bei München, Germany

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Saarbrücken, Germany

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Würzburg, Germany

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Nijmegen, Netherlands

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The Hague, Netherlands

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Drammen, Norway

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Ottestad, Norway

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Cascais, Portugal

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Porto, Portugal

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Barcelona, Spain

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Basel Bs, Switzerland

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Zurich, Switzerland

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Related Publications (2)

• 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.

  PMID: 35201607 DERIVED

• Buitelaar 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.

  PMID: 21798108 DERIVED

Related Links

• 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 Disorder

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Planned sample size for DB phase was 80 subjects. Of 99 subjects at the end of OL phase only 45 subjects consented. No cutoffs for key efficacy assessments in DB entry criteria.

Results Point of Contact

• Title: European Medical Affairs Director Neurology
• Organization: Janssen-Cilag G.m.b.H.

bschaeu2@its.jnj.com

+49 2137 955258

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 28, 2006
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: February 23, 2010

Record last verified: 2014-04

Locations

FR (1); CH (2); ES (1); NL (2); DE (11); PT (2); NO (2)