Trials / Completed
CompletedNCT03758924
Study of ANAVEX2-73 in Patients With Rett Syndrome
A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients With Rett Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Anavex Life Sciences Corp. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study. This is a 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
| Type | Name | Description |
|---|---|---|
| DRUG | ANAVEX2-73 | Liquid oral solution |
| DRUG | Placebo | Liquid oral solution |
Timeline
- Start date
- 2019-02-28
- Primary completion
- 2020-10-30
- Completion
- 2020-10-30
- First posted
- 2018-11-29
- Last updated
- 2021-01-12
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03758924. Inclusion in this directory is not an endorsement.