Trial | NCT03351569  Report issue

Title

Intravenous Immunoglobulin for Unverricht-Lundborg Disease.
Intravenous Immunoglobulin for Unverricht-Lundborg Disease: Single-patient Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1
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.
Study Started
Dec 09
2015
Primary Completion
Dec 06
2016
Study Completion
Dec 30
2017
Anticipated
Last Update
Nov 27
2017

Drug Intravenous immunoglobulin

Intravenous drip.

  • Other names: Venital

Immunoglobulin Experimental

Intravenous immunoglobulin 25 grams (five 100 ml bottles, 5g/100ml), in 3 hours, once a month for one year.

Saline solution Placebo Comparator

Intravenous saline solution 500 ml (five 100 ml bottles), in 3 hours, once a month for one year.

Criteria 

Inclusion Criteria:

Malattia di Unverricht-Lundborg (genetic diagnosis)

Exclusion Criteria:

Contraindications to intravenous immunoglobulin
No Results Posted