Study of ANAVEX2-73 in Patients With Rett Syndrome
NCT03758924 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2021-01-12
Summary
Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study.
7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.
Conditions
Interventions
- DRUG
-
ANAVEX2-73
Liquid oral solution
- DRUG
-
Liquid oral solution
Sponsors & Collaborators
-
International Rett Syndrome Foundation Rettsyndrome.org
collaborator UNKNOWN -
Anavex Life Sciences Corp.
lead INDUSTRY
Principal Investigators
-
Walter Kaufmann, MD · Emory University SOM
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-28
- Primary Completion
- 2020-10-30
- Completion
- 2020-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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