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PharmaTher Initiates P-II KET-LID Study of Ketamine for Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease

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PharmaTher Initiates P-II KET-LID Study of Ketamine for Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease

PharmaTher Initiates P-II KET-LID Study of Ketamine for Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease

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

  | Ref: Globe Newswire | Image: Globe Newswire

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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