Post Polio Syndrome, PPS Clinical Trial
Official 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
| Verified date | September 2005 |
| Source | Pharmalink AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
The primary objective was to assess the effect of Xepol compared to placebo on physical health and on muscle strength in subjects with post-polio syndrome.The secondary objective was to assess the effect of Xepol compared to placebo on functional balance, activity patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking ability, balance and safety.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | May 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Danderyd Hospital | Danderyd | |
| Sweden | Sahlgrenska University Hospital | Gothenburg | |
| Sweden | Huddinge University Hospital | Stockholm | |
| Sweden | Uppsala Academic Hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmalink AB |
Sweden,
Gonzalez H, Khademi M, Andersson M, Piehl F, Wallström E, Borg K, Olsson T. Prior poliomyelitis-IVIg treatment reduces proinflammatory cytokine production. J Neuroimmunol. 2004 May;150(1-2):139-44. — View Citation
Gonzalez H, Khademi M, Andersson M, Wallström E, Borg K, Olsson T. Prior poliomyelitis-evidence of cytokine production in the central nervous system. J Neurol Sci. 2002 Dec 15;205(1):9-13. — View Citation
Gonzalez H, Sunnerhagen KS, Sjöberg I, Kaponides G, Olsson T, Borg K. Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial. Lancet Neurol. 2006 Jun;5(6):493-500. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary endpoints: | |||
| Primary | Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure. | |||
| Primary | Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen. | |||
| Secondary | Secondary endpoints: | |||
| Secondary | Functional balance was assessed by using the Timed “Up and Go” (TUG) test. | |||
| Secondary | Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE). | |||
| Secondary | Pain was assessed by a Visual Analogue Scale and by a pain drawing. | |||
| Secondary | Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. | |||
| Secondary | Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire. | |||
| Secondary | Sleep was assessed using the Sleep quality scale. | |||
| Secondary | Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint. | |||
| Secondary | Walking ability was assessed by a 6 minutes walking test. | |||
| Secondary | Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method. | |||
| Secondary | 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) | |||
| Secondary | Adverse events | |||
| Secondary | Vital signs (blood pressure and heart rate) | |||
| Secondary | Physical examination | |||
| Secondary | Laboratory tests |