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A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome

ConditionStiff Person Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKedrion S.p.A.

About this trial

The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff person syndrome (SPS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18-70 years of age.

Patient has signed the Informed Consent Form (ICF).

Patients must have paravertebral stiffness and torso/lower extremity predominance.

Distribution of stiffness index score of ≥ 2, including stiffness in the legs or trunk.

Disqualifiers

Patients incapable of giving informed consent.

Patients with SPS-plus or variants of SPS such as paraneoplastic or progressive encephalomyelitis with rigidity and myoclonus (PERM). Patients with pure cerebellar ataxia, ocular motor apraxia.

Patients who are bed-bound or wheelchair-dependent.

Ongoing/active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1/2 infection. Subjects with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kedrion IVIg 10%

    Biological/Vaccine

    Intravenous human normal immunoglobulin (IVIg) 10%

  • Human Albumin

    Biological/Vaccine

    Human albumin solution, diluted with saline 0.9% to a final concentration of 0.5% as an intravenous infusion

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Kedrion IVIg 10%Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Timed 25-Foot Walk (T25-FW)

Proportion of participants showing an improvement on the Timed 25-Foot Walk

Time frame
Baseline to Week 24

Secondary outcomes

1

Timed 25-Foot Walk (T25-FW)

Change in the Timed 25-Foot Walk from baseline to Week 24 and, for participants entering the study extension, to Week 48

Time frame
Baseline up to Week 48
2

Distribution-of-Stiffness (DSI)

Change in the scores of the distribution-of-stiffness index (DSI) from baseline to Week 24 and, for participants entering the study extension, to Week 48

Time frame
Baseline up to Week 48
3

Heightened Sensitivity Scale (HSS)

Change in heightened sensitivity scale (HSS) from baseline to Week 24 and, for participants entering the study extension, to Week 48

Time frame
Baseline up to Week 48
4

Modified Rankin Scale (mRS)

Change in Modified Rankin scale (mRS) from baseline to Week 24 and, for participants entering the study extension, to Week 48

Time frame
Baseline up to Week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kedrion S.p.A.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: