The Therapeutic Effect of Thalidomide in Syringomyelia
Recruiting
Phase 2
Interventional Study
Syringomyelia
Thalidomide
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Other
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About This Trial
Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia. Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects,
* or non-effective response to duraplasty and shunting treatment in 12 months prior to study entry.
* Estimated life expectancy must be greater than 12 months.
* Routin…
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