SciSparc Advances Toward Clinical Trial for Tourette Treatment
SciSparc Moves Forward with Clinical Trial Application
In a significant advancement for the treatment of Tourette Syndrome, SciSparc Ltd. (NASDAQ: SPRC), a dedicated clinical-stage pharmaceutical company, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. This application is crucial for the initiation of a Phase IIb clinical trial, aimed at evaluating the effectiveness of its proprietary drug candidate, SCI-110.
Trial Sites and Management
The upcoming clinical trial will take place at three prestigious clinical research centers: the Yale Child Study Center at the Yale School of Medicine in the United States, Hannover Medical School in Germany, and Tel Aviv Sourasky Medical Center in Israel. The approval processes have been successfully completed, with all necessary Institutional Review Board (IRB) permissions granted. Additionally, regulatory approvals from health authorities in both Israel and Germany enable the company to proceed without delay.
Aims of the Clinical Trial
During the Phase IIb trial, the main objective will be to assess the safety, efficacy, and tolerability of SCI-110 in adults diagnosed with Tourette Syndrome, aged between 18 and 65 years. Participants will be randomly assigned to receive either the drug or a placebo, adhering to a well-structured methodology designed to ensure robust results. The effectiveness of SCI-110 will be measured through the Yale Global Tic Severity Scale, an established tool in clinical settings to monitor tic severity.
Potential Impact on Patients
This study aims not only to provide insight into the drug's effectiveness but also to monitor safety parameters closely, including the occurrence of any serious adverse events among participants. Given the challenging nature of Tourette Syndrome, which severely impacts daily functioning for individuals, a successful trial could yield groundbreaking results and pave the way for improved treatment options.
Overview of SciSparc Ltd.
SciSparc Ltd. is on a mission to develop innovative therapies for the central nervous system, with a specific interest in cannabinoid-based pharmaceuticals. The company has formulated a diverse pipeline focused on addressing critical medical needs, such as SCI-110 aimed at treating Tourette Syndrome and SCI-210 designed for conditions like autism spectrum disorders and status epilepticus. Furthermore, SciSparc holds a significant stake in a subsidiary that markets hemp oil-based products through established online platforms.
Frequently Asked Questions
1. What is the primary goal of the Phase IIb clinical trial?
The primary goal is to evaluate the efficacy, safety, and tolerability of SCI-110 in treating Tourette Syndrome in adults.
2. Where will the clinical trial be conducted?
The trial will occur at esteemed institutions including Yale School of Medicine, Hannover Medical School, and Tel Aviv Sourasky Medical Center.
3. What does SCI-110 target?
SCI-110 is developed primarily for treating Tourette Syndrome, aiming to reduce tic severity.
4. How will participants be selected for the trial?
Participants aged 18 to 65 with a diagnosis of Tourette Syndrome will be randomly assigned to either the SCI-110 or placebo group.
5. What is the significance of this trial for patients?
A successful trial could lead to more effective treatment options for individuals suffering from Tourette Syndrome, improving their quality of life.
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