The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson's Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV.
As previously announced on
For further detail about the KET-LID trial (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson's Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.
If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.
“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.
Ketamine’s Potential In Parkinson’s Disease
Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia (LID) was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.
Parkinson’s disease is a debilitating disorder that affects over 1 million people in the
About Parkinson’s Disease
There is currently no cure for Parkinson’s disease. Although the etiology of Parkinson’s disease is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and
About
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
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