Unverricht-Lundborg Disease Clinical Trial
Official title:
Intravenous Immunoglobulin for Unverricht-Lundborg Disease: Single-patient Trial.
Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease.
Single patient randomized double blind trial to assess whether intravenous immunoglobulin can
improve the clinical outcome of a case suffering from Unverricht-Lundborg disease (clinical
and genetic diagnosis).
The patient was randomized to be treated with intravenous immunoglobulin or placebo 1:1
(crossover) once a month for at least one year.
Main objective: improvement of the action myoclonus. Secondary objectives: Improvement in the
overall score and in individual sections of the Unified Myoclonus Rating Scale at one year;
patient preferences based on results at the end of the trial.
The first analyst was scheduled at one year from the start of the trial. The program was to
discuss the patient's analysis data and to let the patient decide in three possible ways: to
continue the trial, to continue treatment with immunoglobulins, to suspend the treatment.
Depending on the decision, it was planned to follow the patient throughout the year after the
analysis, at least for one year.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00368251 -
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
|
Phase 3 | |
| Completed |
NCT00357669 -
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
|
Phase 3 |