Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADS-5102 · 7 trials · 8 indications
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
The T25FW is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
| Arm | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | EXPERIMENTAL | 274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks |
| ADS-5102, 137 mg | EXPERIMENTAL | ADS-5102, administered once daily at bedtime from Week 4 through Week 16 |
| Placebo | OTHER | placebo, administered once daily at bedtime from Week 4 through Week 16 |
| ADS-5102 (amantadine HCl extended release) | EXPERIMENTAL | ADS-5102 (amantadine HCl extended release) |
| ADS-5102 | EXPERIMENTAL | amantadine HCl extended release |
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | ACTIVE_COMPARATOR | Low dose ADS-5102 (amantadine extended release) |
| Treatment C | ACTIVE_COMPARATOR | A mid-dose ADS-5102 (amantadine extended release) |
| Treatment D | ACTIVE_COMPARATOR | High dose ADS-5102 (amantadine extended release) |
| Name | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | DRUG | Oral capsules |
| ADS-5102, 137 mg | DRUG | Oral capsules |
| Placebo | OTHER | Oral capsules |
| ADS-5102 | DRUG | Oral capsules to be administered once nightly at bedtime, for 13 weeks. |
| ADS-5102 (extended release amantadine HCl) | DRUG | Oral capsules to be administered once daily at bedtime, for 8 weeks |
Inclusion Criteria: * Signed a current IRB-approved informed consent form * Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment. Exclusion Criteria: * Based on the judgment of the investigator or Medical Monitor, participation in the study would ...
ADS-5102 is an investigational small molecule being developed for the treatment of levodopa-induced dyskinesia in Parkinson's disease. It is also being studied for walking impairment in multiple sclerosis. The drug is in Phase 3 clinical development and is not yet approved by the FDA.
ADS-5102 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting Phase 3 clinical trials for the drug in levodopa-induced dyskinesia associated with Parkinson's disease.
ADS-5102 is in Phase 3 clinical development. Four clinical trials have been completed, including one Phase 2 study and three Phase 3 studies. The drug remains investigational and has not received FDA approval for any indication.
ADS-5102 has been studied in four completed clinical trials. These include NCT01397422, a Phase 2 study in levodopa-induced dyskinesia; NCT02136914, a Phase 3 study; NCT02202551, an open-label Phase 3 safety study; and NCT02274766, a Phase 3 efficacy and safety study. All trials enrolled patients with Parkinson's disease and levodopa-induced dyskinesia.
ADS-5102 is an extended-release formulation of amantadine, a medication that modulates the glutamate system in the brain. By targeting glutamate receptors, it is designed to reduce the involuntary movements associated with levodopa-induced dyskinesia in Parkinson's disease patients.