Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pridopidine · 1 trial · 1 indication
Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The rate of mortality was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times.
| Arm | Type | Description |
|---|---|---|
| Pridopidine | EXPERIMENTAL | Pridopidine is administered orally twice daily for 24 weeks. |
| Matching Placebo | PLACEBO_COMPARATOR | Matching placebo is administered orally twice daily for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Pridopidine | DRUG | Administration: Oral Dose: 45mg twice daily |
| Matching Placebo | DRUG | Administration: Oral Dose: one capsule twice daily |
Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Parti...
Pridopidine is an investigational small molecule being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 2 clinical development. The drug is being evaluated for its potential to modify the course of the disease, though it is not yet approved for any use.
Pridopidine is being developed by Merit Medical Systems, Inc., a company traded on the NASDAQ under the ticker symbol MMSI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Amyotrophic Lateral Sclerosis.
Pridopidine is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Amyotrophic Lateral Sclerosis, and its Phase 2 trial has been completed.
Pridopidine was studied in a Phase 2 clinical trial with the identifier NCT04615923, titled 'HEALEY ALS Platform Trial - Regimen D Pridopidine'. This was a randomized, double-blind, placebo-controlled trial that enrolled 163 participants with Amyotrophic Lateral Sclerosis in the United States. The trial has been completed.
Pridopidine is a distinct investigational drug and is not known to be the same as any other marketed medication. It is being developed specifically for Amyotrophic Lateral Sclerosis and is currently in Phase 2 clinical trials. No alternative names for Pridopidine have been reported.