Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: double blind placebo; double blind PR OROS methylphenidate; open label PR OROS methylphenidate
Intervention description: matching placebo tablets once daily for 4 weeks; 18, 36, 54,72 or 90 mg/day once daily for 4 weeks; Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Adult; Long term safety; Efficacy; Quality of life

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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