A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the tretment of adult patients with childhood-onset ADHD.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2010-021533-31-NO
• Date of registration: 10/12/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the tretment of adult patients with childhood-onset ADHD.
• Scientific title: A 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the tretment of adult patients with childhood-onset ADHD.
• Date of first enrolment: 13/06/2012
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021533-31
• 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: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Colombia, Denmark, Germany, Norway, Singapore, South Africa, Sweden, United States

Contacts

• Name: Medisinsk Informasjon
• Affiliation: Novartis Norge AS

• Name: Medisinsk Informasjon
• Affiliation: Novartis Norge AS

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Written informed consent must be obtained before any assessment is performed.
2.Patients must be capable of complying with study procedures.
3.Male or female adults from 18-60 years of age.
4.Diagnosis of Attention-Deficit /Hyperactivity Disorder (ADHD) all types with a confirmed childhood onset according to DSM-IV diagnostic criteria.
5.DSM-IV ADHD Rating Scale total score greater than or equal to 30 at Screening and Baseline.
6.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use an effective method of contraception during dosing of study treatment.

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:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
2.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
4.Patients with a BMI < 18.5 kg/m2 or = 30 kg/m2
5.Patients who demonstrate a 30% or greater improvement in the DSM-IV ADHD RS total score at Baseline relative to the score obtained at the Screening Visit.
6.History of alcohol or substance abuse or dependence within the last six months.
7.History of seizures or use of anticonvulsant medication for seizure control (except childhood febrile seizures).
8.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.
9.Pre-existing 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).
10. Evidence upon physical examination or history 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.
11. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
12. Diagnosis or family history of Tourette's syndrome
13.Patients receiving any psychotropic medications. The minimum discontinuation period varies according to drug class follows:
•One week prior to the Screening Visit: stimulants including MPH, antidepressants other than fluoxetine, antipsychotics, anticonvulsants for non-epilepsy uses, mood-stabilizing medications such as lithium, and herbal preparations with psychotropic potential.
•Two weeks prior to the Screening Visit: benzodiazepines, barbiturates, all other sedatives or hypnotics, and monoamine oxidase inhibitors (MAOIs).
•Four weeks prior to the Screening Visit: Fluoxetine.
14.Patients receiving any psychological or behavioral therapies for the treatment of ADHD. Such therapies must be discontinued at least one month prior to the Screening Visit.
15.Patients who have initiated any psychological or behavioral therapies for reasons other than ADHD within three months prior to the Screening Visit. If it has been ongoing for at least three months with the same therapist, the patient may be eligible to enter the study provided that it is continued throughout the study.
16.Patients who, in the investigator’s judgment, have a history of poor response or intolerance to stimulants (e.g. methylphenidate, dexmethylphenidate, amphetamine salts, dextroamphetamine salts).
17. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke. No additional exclusions may be applied by the investigator, in order to ensure that the study population wil

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: 15.0 Level: LLT Classification code 10003737 Term: Attention deficit/hyperactivity disorder NOS System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 15.0 Level: PT Classification code 10003736 Term: Attention deficit/hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 15.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders

Intervention(s)

Trade Name: Ritalin
Product Code: RIT124D
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Other descriptive name: none
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 40-80
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: •The key secondary objective is to evaluate overall improvement as measured by the proportion of patients with clinical improvement on the Clinical Global Impression – Improvement Scale (CGI-I) at the end of a 9-week fixed-dose treatment period.

Main Objective: •To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score.
•To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period.
•To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period.
•To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.

Primary end point(s): •Change from baseline to the end of the Period 1 treatment (week 9) in the total score of the DSM-IV ADHD RS (Primary 1) .This will be analyzed for the FAS P1 population.
•Change from baseline to end of Period 1 treatment (week 9) in the SDS total score (Primary 2). This will be analyzed for the FAS P1 population.
•Percentage of treatment failures, predefined as at least a 30% worsening on ADHD RS from Period 3 baseline (randomization 2) to the end of Period 3 (Primary 3). This will be analyzed for the FAS P3 population.

Secondary ID(s)

2010-021533-31-DE

CRIT124D2302

Source(s) of Monetary Support

Novartis Pharma Services A.G

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 03/03/2017
• Date Completed: 07/08/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-021533-31/results