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A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Phase 3 trial testing SM-13496 in Bipolar I Disorder in 495 participants. Completed in 17 February 2018.
| Lead sponsor | Sumitomo Pharma Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 495 |
| Start date | 29 January 2014 |
| Primary completion | 8 February 2018 |
| Estimated completion | 17 February 2018 |
| Sites | 8 locations across Japan, Russia, Slovakia, Malaysia, Ukraine, Taiwan, Philippines, Lithuania |
Sumitomo Pharma Co., Ltd. — full company profile →
Adults 18 to 74, any sex, with Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number and percentage of subjects with at least one adverse event and adverse drug reaction
| Group | Value | 95% CI |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | 352 | |
| SM-13496 20-120mg (Japan, 52 Weeks) | 169 |
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
| Group | Value | 95% CI |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | -4.4 | ± 12.09 |
| SM-13496 20-120mg (Japan, 52 Weeks) | 1.1 | ± 12.58 |
YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 ite
| Group | Value | 95% CI |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | -1.0 | ± 4.54 |
| SM-13496 20-120mg (Japan, 52 Weeks) | -2.0 | ± 6.73 |
The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
| Group | Value | 95% CI |
|---|---|---|
| SM-13496 20-120mg (Overall, 28 Weeks) | 14 | |
| SM-13496 20-120mg (Japan, 52 Weeks) | 18 |
Time frame: Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SM-13496 20-120mg (Overall… | SM-13496 20-120mg (Japan, … |
|---|---|---|---|
| Disease progression | General disorders | — | — |
| Suicide attempt | Psychiatric disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Pelvic fracture | Injury, poisoning and procedural complications | — | — |
| Blood potassium decreased | Investigations | — | — |
| Glucose urine present | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — |
| Lactic acidosis | Metabolism and nutrition disorders | — | — |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | — | — |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Akathisia | Nervous system disorders | — | — |
| Psychomotor hyperactivity | Nervous system disorders | — | — |
| Alcoholism | Psychiatric disorders | — | — |
| Hallucination, auditory | Psychiatric disorders | — | — |
| Hallucination, visual | Psychiatric disorders | — | — |
| Mania | Psychiatric disorders | — | — |
| Suicidal ideation | Psychiatric disorders | — | — |
| Reaction | System | SM-13496 20-120mg (Overall… | SM-13496 20-120mg (Japan, … |
|---|---|---|---|
| Akathisia | Nervous system disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Somnolence | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Parkinsonism | Nervous system disorders | — | — |
| Weight increased | Investigations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Disease progression | General disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dystonia | Nervous system disorders | — | — |
Most-reported serious reactions: Disease progression, Suicide attempt, Urinary tract infection, Pelvic fracture, Blood potassium decreased, Glucose urine present, Weight decreased, Diabetes mellitus.
Data from ClinicalTrials.gov NCT01986114 adverse events section.
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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