Attention Deficit-Hyperactivity Disorder (ADHD) MedDRA version: 7.1 Level: LLT Classification code 10003735
Conditions
Interventions
Trade Name: Concerta 18 mg Retardtabletten
Product Name: CONCERTA 18 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: methylphenidate hydrochloride
CAS Number: 113-45-1
Concentrat
Sponsors
Janssen-Cilag Medical Affairs EMEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1.Subjects can be male or female. 2.Age must be aged between 18 and 65 years, inclusive. 3. Diagnosis of ADHD according to the Diagnostic and Statiscal Manual of Mental Diseases, Fourth Edition (DSM-IV) (1,32) and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV 4.Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years and continue to meet DSM-IV criteria at the time of assessment. ADHD is not diagnosed if the symptoms are better accounted for by another psychiatric disorder (e.g. mood disorder (especially bipolar disorder), anxiety disorder, psychotic disorder, personality disorder) 5.Completion of the open label phase in the 42603ATT3002 trial according to protocol, or within 30 days of completion of the open label phase 6.Female subjects of child-bearing potential must agree to use an acceptable form of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilisation) before entry and throughout the study, and must have a negative urine pregnancy test at screening 7.Informed Consent Form signed by the subject 8.Subject agrees to take only the supplied study drug as treatment for ADHD during the study 9.Subject agrees not to initiate a new behavioural modification programme during the study or if currently using a behavioural modification programme and agrees not to change this programme during the study. 10.Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments. 11.Healthy on the basis of a physical examination, medical history and anamnesis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1.Known to be a non-responder to methylphenidate, or subject has a child known to be a non-responder to methylphenidate. 2.Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate. 3.Has been treated with any methylphenidate-containing medication within 1 month of screening visit, except trial medication provided in 42603ATT3002 trial 4.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. 5.Subjects with a family history of schizophrenia or family history of affective psychosis. 6.Autism or Asperger’s syndrome. 7.Subjects with presence of motor tics, history of Tourette’s syndrome or family history of Tourette’s syndrome. 8.A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary). Episodic abuse in the past is not an exclusion criterion. 9.Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an eating disorder. 10.Known or suspected mental retardation. 11.Hyperthyroidism, myocardial infarction or stroke in the 6 months prior to screening for this study. 12.Subjects with history of seizures, glaucoma or uncontrolled hypertension. 13.Subjects with angina pectoris or cardiac arrhythmias 14.Pregnant or breast-feeding females. 15.Any co-existing medical condition or taking any concomitant medication that is likely to interfere with safe administration of methylphenidate including any herbal or homeopathic remedies; herbal and over-the-counter weight loss or diet preparations or drugs that contain stimulants. 16.Use of monoamine oxidase inhibitors. 17.Use of other anti-depressants (unless subject has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue so 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. 18.Use of clonidine or other alpha-2 adrenergic receptor agonists, antipsychotic medications, theophylline, coumarin anticoagulants, anticonvulsants. 19.Subjects who have clinically significant gastrointestinal problems, including severe narrowing (pathologic or iatrogenic) of the gastrointestinal tract. 20.Subjects who are unable to swallow the study medication whole with the aid of liquids (participants may not chew, divide, dissolve or crush the study medication). 21.History of severe drug allergy or hypersensitivity. 22.Any serious illnesses including, but not limited to liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. 23.Confirmed cancer or malignancy. 24.Employee of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the open label study is to assess long term safety and tolerability of PR OROS methylphenidate in a flexible dose regimen (18-90 mg/day) in adult subjects diagnosed with ADHD. The primary objective of the double-blind, randomized, placebo-controlled phase is to evaluate if benefits continue after cessation of treatment with PR OROS methylphenidate at the optimal dose attained during the open-label phase. ;Secondary Objective: open-label ph: - l. t. efficacy of PR OROS m.ph. expressed as a function of change in the sum of the inattention and hyperactivity/impulsivity subscales of the invest.-rated CAARS - l.t. effect on ADHD symptoms by means of change in total CAARS subscales scores - l.t. term effect on overall functioning, work, family and social functioning, and quality of life param. as measured by CGI-S, CGI-C, SDS, Q-LES-Q, GAE and CAARS:S, respectively double-blind ph: -invest.’s assessment of treatment efficacy by means of GAE, SDS and Q-LES-Q. - subject’s self report of ADHD symptoms associated with the use of PR OROS m.ph. compared with placebo (CAARS-S:S) -effect of PR OROS m.ph. comp. w. pl. on the CGI-S and CGI-C. - nr of subj showing an increase of less than 30%, 30-50%, or more than 50% in the investigator-rated CAARS total score and of subj with score 0-17 at d-bl end point in the PR OROS m.ph. group and the placebo group. - safety through AE reporting, vital signs and clin.lab. ;Primary end point(s): The primary objective of this study is to evaluate the long term safety and tolerability of Concerta. Safety and tolerability will be evaluated on the basis of AE reporting, vital signs and clinical laboratory tests The primary objective of the double-blind, randomized, placebo-controlled phase is to evaluate if benefits continue after cessation of treatment with PR OROS methylphenidate at the optimal dose attained during the open-label phase. | — |
Countries
Germany, Portugal, Spain
Outcome results
None listed