Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00160082
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Pharmalink AB
• Public title: Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
• Scientific title: Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS): A Randomized, Two-Arm, Parallel, Double-Blind, Multi-Centre, Placebo Controlled Study
• Date of first enrolment: January 2001
• Target sample size: 124
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00160082
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Kristian Borg, MD, Prof
• Affiliation: Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subjects =18 to =75 years of age.

2. Post-polio syndrome according to Halstead and Gawne:

- History of polio virus infection

- Restitution or improvement regarding motor function and disabilities after
initial infection

- Confirmed polio by EMG

- Subjectively increased muscular weakness after a period of at least 15 years
functional stability

- No other explanation but post-polio syndrome to the symptoms

3. Confirmed polio by EMG in the lower extremities in at least two of the following
major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two
affected muscle groups in the same extremity were accepted).

4. Subjectively increased muscular difficulties or pain after a period of at least 15
years functional stability.

5. A muscle that had deteriorated within the last five years, and had 20-75 % of the
muscle strength compared to age matched normal population when measured by a
dynamometer or an electronic grip force sensor (GRIPPIT).

6. Stable weight (defined as weight change <7 kg) during the last five years.

7. Body Mass Index (BMI) £ 29 kg/m2.

8. Subjects capable to understand given information and had signed the Informed Consent
Form after full discussion of the research nature of the treatment and its risks and
benefits.

Exclusion Criteria:

1. Known or suspected intolerance to trial product or related products (e.g. sorbitol,
glucose and fructose).

2. Selective IgA deficiency.

3. Inability to walk with walking aids.

4. Any active malignancy, history of active malignancy or treatment for malignancy
during the last three years.

5. Disabling pain from extremities or skeletal system due to previous fracture(s),
arthritis or other reasons not related to PPS.

6. Subjects who received or who within 12 weeks prior to enrolment received any
immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids
excluded).

7. Treatment with intravenous human immunoglobulin for the Post-polio syndrome within
six months prior to the first screening visit.

8. Participation in any other study during this study and the receipt of any
investigational drug within three months prior to the screening visit.

9. Pregnancy or lactation or females of childbearing potential taking inadequate
measures to prevent pregnancy.

10. Hepatitis or HIV disease.

11. Increased liver enzymes (ASAT, ALAT, ?GT) above twice the upper normal value.

12. Creatine kinase >10 mkat/l.

13. Any disease or treatment that according to the discretion of the Investigator could
pose a medical threat to the subject in combination with study drug, i.e. clinical
manifested severe cardiovascular disease or severe arteriosclerosis or severe
psychiatric disorder or other treatment that affected the immunological system such
as prednisone and methotrexate.

14. Any disease or condition that according to the discretion of the Investigator would
obstruct the subject from performing the tests in the protocol (e.g. fill in the
questionnaires).

15. Conditions associated with a risk of poor protocol compliance (e.g. known drug or
alcohol abuse).

16. Previous participation in the study.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Post Polio Syndrome, PPS

Intervention(s)

Drug: Xepol

Primary Outcome(s)

Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.

Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.

Primary endpoints:

Secondary Outcome(s)

Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.

Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method.

Walking ability was assessed by a 6 minutes walking test.

Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE).

Sleep was assessed using the Sleep quality scale.

Secondary endpoints:

Balance was assessed as postural sway velocity and the subject’s ability to voluntarily sway to various locations in space (NeuroCom Balance Master) or balance assessed by static and dynamic posturography (Chattecx® balance system)

Adverse events

Functional balance was assessed by using the Timed “Up and Go” (TUG) test.

Laboratory tests

Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint.

Pain was assessed by a Visual Analogue Scale and by a pain drawing.

Vital signs (blood pressure and heart rate)

Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire.

Physical examination

Secondary ID(s)

IvIG 1/00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors