A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2011-000210-19-DK
• Date of registration: 05/05/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD
• Scientific title: A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD
• Date of first enrolment: 10/05/2011
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000210-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Denmark, Germany, Sweden

Contacts

• Name: Klinisk Forskningsafdeling
• Affiliation: Novartis Healthcare A/S

• Name: Klinisk Forskningsafdeling
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion criteria

Inclusion criteria:
•Patients who have completed the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments,
or
patients who met the predefined criteria for treatment failure (=30% worsening on DSM IV ADHD RS during Period 3 of the core study), were withdrawn from the core study, and have completed core-study Week 40 assessments (Premature Discontinuation Visit).
•Patients must give written informed consent before any study related activity of this extension protocol is performed.

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 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Patients who during the core study developed any psychiatric condition, including anxiety, tension, agitation, aggressive behavior, psychotic symptoms, suicidal tendency, that requires treatment with medication or that, in the judgment of the investigator, may interfere with study participation and /or study assessments.
•Patients who during the core study developed cardiovascular disorders including severe hypertension, angina, arterial occlusive disease, heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
•Evidence upon physical examination during the core study of any clinically significant respiratory, hepatic, gastrointestinal, renal, hematological, or oncologic disorder requiring current medical intervention/therapy or likely to have a significant impact on the outcome of this study
•Patients with a positive urine drug test at the End of Study (Week 40)/Premature discontinuation visit.
•Patients with an abnormal ECG at the End of Study (Week 40)/Premature discontinuation visit.
•Patients who developed any seizure condition during the core study.
•Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
•Diagnosis or family history of Tourette’s syndrome.



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

Health Condition(s) or Problem(s) studied

Adult patients with childhood-onset Attention Deficit Hyperactivity Disorder
MedDRA version: 13.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 13.1 Level: LLT Classification code 10003737 Term: Attention deficit/hyperactivity disorder NOS System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 13.1 Level: PT Classification code 10003736 Term: Attention deficit/hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders

Intervention(s)

Product Code: RIT124D
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Current Sponsor code: 304417_S21_M_967_1
Other descriptive name: none
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 40-80

Primary Outcome(s)

Main Objective: •To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD.

Secondary Objective: •To characterize the long-term benefit of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD, as measured by the change from baseline (Core study Visit 20, Week 40 or early discontinuation visit) to the end of the extension study (Visit 30, Week 66) in DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score
•To evaluate improvement in functional impairment as measured by change from baseline in total score on the Sheehan Disability Scale (SDS).

Primary end point(s): To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD. The evaluation of safety is considered primary in this open-label extension.

Secondary ID(s)

2011-000210-19-DE

CRIT124D 2302 E1