Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK0249 · 3 trials · 3 indications
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.
The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.
| Arm | Type | Description |
|---|---|---|
| MK0249 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| MK-0249 | EXPERIMENTAL | Total time in the study will be \~10 weeks. |
| Concerta | ACTIVE_COMPARATOR | Total time in the study will be \~10 weeks. |
| Name | Type | Description |
|---|---|---|
| MK0249 | DRUG | MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days. |
| Comparator: Placebo (unspecified) | DRUG | MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period. |
| Concerta (methylphenidate) | DRUG | Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily. |
| Placebo | DRUG | For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily. |
Inclusion Criteria: * Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months * Patient has a 6th grade reading level or better * Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth...
Top 20 of 24 competitors
MK0249 is an investigational small molecule being studied for the symptomatic treatment of Alzheimer's disease, for cognitive impairment in patients with paranoid schizophrenia, and for attention-deficit/hyperactivity disorder (ADHD). It has been evaluated in Phase 2 clinical trials for these neurological conditions.
MK0249 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company has sponsored clinical trials of MK0249 in Alzheimer's disease, ADHD, and paranoid schizophrenia.
MK0249 is in Phase 2 clinical development. It has completed Phase 2 trials for Alzheimer's disease, ADHD, and paranoid schizophrenia. MK0249 is investigational and has not been approved by regulatory authorities for any use.
MK0249 has completed three Phase 2 trials. NCT00420420 studied MK0249 for symptomatic treatment of Alzheimer's disease in 144 patients aged 55 and older. NCT00475735 tested it in 72 adults with ADHD. NCT00506077 evaluated it in 55 patients with paranoid schizophrenia.
MK0249 is a distinct investigational compound developed by Merck. It has been tested separately in paranoid schizophrenia, ADHD, and Alzheimer's disease. No alternative names for MK0249 have been reported in its clinical trial records.