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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512949-17-00
Acronym
SCI-021-001
Enrollment
56
Registered
2024-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette's syndrome in adults (≥18 and ≤65 years) in out-patient care

Brief summary

[CCI]

Detailed 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.

Interventions

DRUGSCI-110 Placebo Drug Product
DRUGSCI-110_DF1
DRUGSCI-110_DF3
DRUGSCI-110_DF2

Sponsors

Neurothera Labs Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
[CCI]

Secondary

MeasureTime frame
[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.

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026