A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day), with open-label extension, in adults with attention deficit/ hyperactivity disorder. - LAMDA

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000730-37-SE
• Date of registration: 15/12/2004
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag Medical Affairs EMEA
• Public title: A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day), with open-label extension, in adults with attention deficit/ hyperactivity disorder. - LAMDA
• Scientific title: A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day), with open-label extension, in adults with attention deficit/ hyperactivity disorder. - LAMDA
• Date of first enrolment: 07/02/2005
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000730-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Open label study extenstion after double-blind phase If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Finland, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
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 Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1,50 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.CAARS score of >= 24 as determined by investigator at screening visit.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, anamnesis, and the results of blood biochemistry or haematology tests. If the results of the biochemistry or haematology tests are not within the laboratory's normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant. This should be clearly recorded in the subject's source documents and the Trial Manager informed.
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:
1.Known to be a non-responder to methylphenidate, or subject has a child known to be a non-responder to methylphenidate.2.Has been treated with any methylphenidate-containing medication within 3 months of screening visit. Three months is considered a reasonable time for patients treated with methylphenidate to return to a disease status baseline.3.Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate.4.Any clinically unstable psychiatric condition including the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social 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, except if tapering off, within 4 weeks of the baseline visit.17.Use of other anti-depressants (unless subject has been on a stable dosage for at least 3 months prior to screening, 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), except if tapering off, within 2 weeks of the baseline visit (for fluoxetine within 4 weeks). 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 insuffiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. 23. Confirmed cancer or malignancy. 24. Participation in an investigational drug trial in the 30 days prior to selection. 25. 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Attention Deficit Hyperactivity Disorder (ADHD)
Classification code 10003731

Intervention(s)

Trade Name: Concerta
Product Name: Concerta XL 18 mg
Product Code: CAS:113-45-1
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: methylphenidate hydrochloride
CAS Number: 113-45-1
Current Sponsor code: N/A
Other descriptive name: methylphenidate hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Concerta
Product Name: Concerta XL 36 mg
Product Code: N/A
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: methylphenidate hydrochloride
CAS Number: 113-45-1
Current Sponsor code: N/A
Other descriptive name: methylphenidate hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 36-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Concerta
Product Name: Concerta XL 54 mg
Product Code: N/A
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: methylphenidate hydrochloride
CAS Number: 113-45-1
Current Sponsor code: N/A
Other descriptive name: CAS113-45-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 54-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary end point in the double-blind treatment phase will be the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated CAARS from baseline to last post-randomisation assessment in the double-blind treatment period.

Main Objective: The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of Prolonged Release (PR) OROS methylphenidate (18, 36 and 72 mg/day) compared with placebo in adult subjects with attention deficit/hyperactivity disorder (ADHD). The efficacy response will be measured by the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS), from start of treatment to the end of the double-blind phase.

Secondary Objective: Assessment of the following, associated with the use of PR OROS methylphenidate (Concerta) compared with placebo: The global improvement in severity of illness; subject's self report of reduction of ADHD symptoms; the benefits to work, family and social functioning; investigator's assessment of treatment effectiveness, dose-response relationship of Concerta; safety on the basis of AE reporting, vital signs and clinical laboratory tests. The objective of the open-label extension is to assess safety and tolerability of Concerta in a flexible dose regimen (18-90 mg/day) in adult subjects diagnosed with ADHD. The effect in the open-label extension is assessed using the same assessments as mentioned above (primary and secondary objective in the double-blind phase).

Secondary ID(s)

42603ATT3002

N/A