Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rivastigmine · 5 trials · 5 indications
The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.
The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.
| Arm | Type | Description |
|---|---|---|
| Rivastigmine capsule | EXPERIMENTAL | Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76. |
| Rivastigmine patch | EXPERIMENTAL | Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76. |
| Name | Type | Description |
|---|---|---|
| Rivastigmine capsule | DRUG | Rivastigmine capsules orally twice a day. Target dose 12 mg/day. |
| Rivastigmine transdermal patch | DRUG | Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period. |
| Rivastigmine | DRUG | - |
Inclusion Criteria: * Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria * Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symp...
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Rivastigmine is an investigational small molecule in Phase 3 clinical development for neurological conditions including Alzheimer's Disease, Vascular Dementia, Parkinson's Disease Dementia, and Traumatic Brain Injury. It is being studied for its effects on cognitive disorders associated with these conditions.
Rivastigmine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in various dementia and cognitive impairment indications.
Rivastigmine is in Phase 3 clinical development. It has completed four Phase 3 trials, with no active trials currently ongoing. The drug remains investigational and has not been reported as approved by regulatory authorities for the studied indications.
Rivastigmine has completed four Phase 3 clinical trials: NCT00000174 in Alzheimer's Disease, NCT00130338 in Vascular Dementia, NCT00171795 in Traumatic Brain Injury, and NCT00623103 in Parkinson's Disease Dementia. These trials were completed with a total enrollment of approximately 3,268 participants across multiple countries.
Rivastigmine is the generic name for the drug marketed under the brand name Exelon. Clinical trial NCT00000174, titled 'Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)', uses the brand name Exelon to refer to the same drug substance.