Intravenous Immunoglobulin for Unverricht-Lundborg Disease.

A

Azienda Socio Sanitaria Territoriale di Mantova

Status and phase

Unknown
Phase 3

Conditions

Unverricht-Lundborg Disease

Treatments

Drug: Intravenous immunoglobulin

Study type

Interventional

Funder types

Other

Identifiers

NCT03351569
200200
2017-002147-15 (EudraCT Number)

Details and patient eligibility

About

Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease.

Full description

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.

Enrollment

1 patient

Sex

Male

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Malattia di Unverricht-Lundborg (genetic diagnosis)

Exclusion criteria

Contraindications to intravenous immunoglobulin

Trial design

1 participants in 2 patient groups, including a placebo group

Immunoglobulin
Experimental group
Description:
Intravenous immunoglobulin 25 grams (five 100 ml bottles, 5g/100ml), in 3 hours, once a month for one year.
Treatment:
Drug: Intravenous immunoglobulin
Saline solution
Placebo Comparator group
Description:
Intravenous saline solution 500 ml (five 100 ml bottles), in 3 hours, once a month for one year.
Treatment:
Drug: Intravenous immunoglobulin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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