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

NCT00160082 | Completed

• 1 other identifier: IvIG 1/00
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Post Polio Syndrome, PPS

Keywords

Post Polio Syndrome; PPS; Poliomyelitis; Paralylic Polio; Late effects of polio; Late onset polio sequele; Xepol; IvIg; Intravenous Immunoglobuline

Outcome Measures

Primary Outcomes (3)

• Primary endpoints:

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

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

Secondary Outcomes (15)

• Secondary endpoints:

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

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

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

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

Interventions

Xepol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 to ≤75 years of age.
• 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
• 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).
• Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability.
• 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).
• Stable weight (defined as weight change \<7 kg) during the last five years.
• Body Mass Index (BMI) £ 29 kg/m2.
• 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.

You may not qualify if:

• Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose).
• Selective IgA deficiency.
• Inability to walk with walking aids.
• Any active malignancy, history of active malignancy or treatment for malignancy during the last three years.
• Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS.
• Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded).
• Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit.
• Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit.
• Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy.
• Hepatitis or HIV disease.
• Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value.
• Creatine kinase \>10 mkat/l.
• 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.
• 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).
• Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse).

Sponsors & Collaborators

• Calliditas Therapeutics AB: lead

Study Sites (4)

Danderyd Hospital

Danderyd, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Huddinge University Hospital

Stockholm, SE-141 86, Sweden

Location

Uppsala Academic Hospital

Uppsala, Sweden

Location

Related Publications (3)

• Gonzalez H, Khademi M, Andersson M, Wallstrom 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. doi: 10.1016/s0022-510x(02)00316-7.

  PMID: 12409177 BACKGROUND

• Gonzalez H, Khademi M, Andersson M, Piehl F, Wallstrom E, Borg K, Olsson T. Prior poliomyelitis-IVIg treatment reduces proinflammatory cytokine production. J Neuroimmunol. 2004 May;150(1-2):139-44. doi: 10.1016/j.jneuroim.2004.01.010.

  PMID: 15081258 BACKGROUND

• Gonzalez H, Sunnerhagen KS, Sjoberg 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. doi: 10.1016/S1474-4422(06)70447-1.

  PMID: 16713921 RESULT

Related Links

• Pharmalink AB (sponsor)
• PhD Disertation, Henrik Gonzalez, The post-polio syndrome: Studies of immunology and immunomodulatory intervention

MeSH Terms

Conditions

Postpoliomyelitis Syndrome; Popliteal Pterygium Syndrome; Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Kristian Borg, MD, Prof

  Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2001
• Study Completion: May 1, 2003
• Last Updated: April 3, 2007

Record last verified: 2005-09

Locations

SE (4)