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Also known as Nuvigil, CEP-10953, R-modafinil
Armodafinil · 14 trials · 14 indications
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.
The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term "ill" refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here.
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 \[midnight\], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).
Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.
PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.
The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks. |
| Armodafinil 150 mg/day | EXPERIMENTAL | Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks. |
| 1 | EXPERIMENTAL | Armodafinil 250 mg/day |
| 2 | EXPERIMENTAL | Armodafinil 150 mg/day |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Armodafinil 200 mg/day | EXPERIMENTAL | Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. |
| 50 mg/day armodafinil | ACTIVE_COMPARATOR | Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets each morning. |
| 100 mg/day armodafinil | ACTIVE_COMPARATOR | Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 100 mg/day armodafinil treatment arm for the double-blind treatment period of the study took two 50 mg armodafinil tablets plus two placebo tablets each morning. Subjects began taking 50 mg/day and then titrated to 100 mg/day on Day 2 of the first week of the double-blind treatment period. |
| 200 mg/day armodafinil | ACTIVE_COMPARATOR | Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 200 mg/day armodafinil treatment arm for the double-blind treatment period of the study took four 50 mg armodafinil tablet and no placebo tablets each morning. Subjects were titrated to this dose by starting treatment at 50 mg/day (1 tablet) and increasing by 50 mg increments on days 2, 4, and 6 until they were taking 200 mg/day. |
| 150 mg/day armodafinil | ACTIVE_COMPARATOR | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. |
| 250 mg/day armodafinil | ACTIVE_COMPARATOR | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. |
| Matching Placebo | PLACEBO_COMPARATOR | At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study. |
| Armodafinil | ACTIVE_COMPARATOR | - |
| Armodafinil 50 mg | EXPERIMENTAL | In period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42. |
| Armodafinil 100 mg | EXPERIMENTAL | In period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42. |
| Armodafinil 150 mg | EXPERIMENTAL | In period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42. |
| Name | Type | Description |
|---|---|---|
| Armodafinil | DRUG | Armodafinil tablets, taken orally, once daily in the morning |
| Placebo | DRUG | Matching placebo tablets, taken orally, once daily in the morning |
| CEP-10953 (Armodafinil) | DRUG | Armodafinil (po) 100 to 250 mg/day up to 12 months |
| Armodafinil 250 mg/day | DRUG | Armodafinil 250 mg once daily in the morning |
| Armodafinil 150 mg/day | DRUG | Armodafinil 150 mg once daily in the morning |
Inclusion Criteria: * The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode. * Documentation that the patient has had at least...
Armodafinil is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It is being studied in psychiatry for conditions including bipolar I depression, depression, excessive daytime sleepiness, excessive sleepiness, narcolepsy, and obstructive sleep apnea. It is given orally at doses such as 150 mg/day and 250 mg/day.
Armodafinil is being investigated for excessive daytime sleepiness, excessive sleepiness, narcolepsy, obstructive sleep apnea, depression, and bipolar I depression. It is not yet approved for these uses and remains an investigational therapy in clinical development.
Armodafinil targets SLC6A3, also known as the dopamine transporter. It acts as an inhibitor of this target. By inhibiting SLC6A3, armodafinil affects dopamine reuptake, which is thought to contribute to its wake-promoting and mood-related effects.
Armodafinil is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor responsible for the clinical development program of armodafinil.
Armodafinil is in Phase 2 of clinical development according to the available data. It has not been approved by the FDA for the indications being studied. The program includes completed Phase 3 trials in bipolar I depression, but the overall development stage is listed as Phase 2.
Armodafinil has been studied in several completed clinical trials, including NCT01624480, a Phase 1 pharmacokinetic and safety study in children and adolescents with narcolepsy, and three Phase 3 trials in adults with major depression associated with bipolar I disorder: NCT01305408, NCT01072929, and NCT01072630. All trials are completed.