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Active (not recruiting) Phase 2 2024-512949-17-00

A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults with Tourette Syndrome

Phase 2 – studying effectiveness and dosage
Conditions: Tourette's syndrome in adults (≥18 and ≤65 years) in out-patient care

Sponsor: Neurothera Labs Inc.

trial.available_in: БГ
Overview
Trial status: Authorised [CCI], [CCI], [CCI], [CCI], [CCI], [CCI], [CCI], Number of adverse events (AEs), number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs leading to withdrawal at each visit., Absolute values of vital signs (blood pressure, heart rate) at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values. [CCI]
Description
[CCI], [CCI], [CCI], [CCI], [CCI], [CCI], [CCI], Number of adverse events (AEs), number and rate of patients affected by AEs, SAEs, SUSARs/ADRs, AESIs and AEs leading to withdrawal at each visit., Absolute values of vital signs (blood pressure, heart rate) at each visit and change from baseline for each visit. Number and percentage of clinically significant abnormal values.
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 56 participants
Interventions
SCI-110 Placebo Drug Product
Drug
SCI-110_DF1
Drug
SCI-110_DF2
Drug
SCI-110_DF3
Drug
Locations 1
Germany (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.07.2024
Registry ID
2024-512949-17-00
Source
euclinicaltrials.eu
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