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Currently Enrolling Trials

General Information

Ritalin LA is a new once-daily formulation of Ritalin, Novartis' previously approved ADHD treatment. This once-daily capsule provides all day treatment with one morning dose, unlike most ADHD treatments that require a midday dose. This dosing regimen eliminates the social stigma issues felt by children having to bring medication to school and decreases the possibility of medication misuse.

ADHD is the most commonly diagnosed psychiatric disorder among school-aged children. Symptoms include inattentive, impulsive and hyperactive behavior that interferes with a child's ability to properly function in academic and social settings.

Clinical Results

The approval of Ritalin LA is based on results from a randomized, double-blind, placebo-controlled study involving 134 pediatric subjects, ages 6 to 12, with DSM IV diagnoses of ADHD. Subjects received a single morning dose of Ritalin LA or placebo, for up to two weeks. Efficacy was measured through the Conners ADHD Scale for Teachers (CADS-T), completed at baseline and the end of each week by the child's regular school teacher. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline scores to those during the last week of treatment was analyzed as the primary efficacy parameter. Subjects treated with Ritalin LA showed a statistically significant improvement in symptom scores from baseline over those who received placebo.

Side Effects

Adverse events associated with the use of Ritalin LA may include (but are not limited to) the following:

Headache
Insomnia
Upper abdominal pain
Decreased appetite
Anorexia

Mechanism of Action

Ritalin LA (methylphenidate HCl) is a central nervous system stimulant. The exact mechanism of action in ADHD is unknown. The drug is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. (Ritalin LA prescribing information)