Shots:
- The company initiates P-II KET-LID clinical trial to evaluate the safety, efficacy, and PK of Ketamine (sub-anesthetic, IV) vs PBO in patients with LID associated with PD. The patient enrollment is expected to initiate in Oct’21 with an anticipated PDUFA date on Q4’21
- The 1EPs & 2EPs are the changes in the total score & objective score (III, IV) of UDysRS, total daily OFF times as assessed by patients completed 24hrs. diaries along with a total score of UPDRS part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV
- The company plans to discuss with the US FDA to initiate a P-III clinical study under the 505(b)2 regulatory pathway in H1’22, based on the P-II results
Click here to read full press release/ article | Ref: Globe Newswire | Image: Globe Newswire
The post PharmaTher Initiates P-II KET-LID Study of Ketamine for Levodopa-Induced Dyskinesia in Patients with Parkinson’s Disease first appeared on PharmaShots.
