NCT00160082 is a NA clinical trial of Xepol in Post Polio Syndrome, PPS, sponsored by Calliditas Therapeutics AB.

Who is sponsoring NCT00160082?

NCT00160082 is sponsored by Calliditas Therapeutics AB.

What drugs are being tested in NCT00160082?

Interventions in NCT00160082: Xepol.

What condition does NCT00160082 study?

NCT00160082 studies Post Polio Syndrome, PPS.

Is NCT00160082 still recruiting?

NCT00160082 is currently completed. Last updated 2 April 2007.

Last reviewed 2007-04-02 · How we verify

NCT00160082

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 2 April 2007

What this trial tests

NA trial testing Xepol in Post Polio Syndrome, PPS in 124 participants. Completed in 1 May 2003.

Timeline

1 January 2001

1 May 2003

Quick facts

Lead sponsor	Calliditas Therapeutics AB
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	124
Start date	1 January 2001
Estimated completion	1 May 2003
Sites	4 locations across Sweden

Drugs / interventions tested

Xepol — full drug profile →

Conditions studied

Post Polio Syndrome, PPS — all drugs for Post Polio Syndrome, PPS →

Sponsor

Calliditas Therapeutics AB — full company profile →

Who can join

Adults 18 to 75, any sex, with Post Polio Syndrome, PPS. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.
Gonzalez H, Sunnerhagen KS, Sjöberg I, Kaponides G, et al · · 2006 · cited 61× · PMID 16713921 · DOI 10.1016/s1474-4422(06)70447-1
Treatment for postpolio syndrome.
Koopman FS, Beelen A, Gilhus NE, de Visser M, et al · · 2015 · cited 28× · PMID 25984923 · DOI 10.1002/14651858.cd007818.pub3

Verify or expand the search:

Other Calliditas Therapeutics AB trials

Trials by the same sponsor.

NCT06274489 — A Study to Evaluate Setanaxib in Patients With Alport Syndrome · Phase 1, PHASE2 · completed
NCT04541043 — Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE) · Phase 3 · completed
NCT04327089 — Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects · Phase 1 · completed
NCT03740217 — Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets · Phase 1 · completed
NCT03643965 — Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00160082 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Calliditas Therapeutics AB
Last refreshed: 2 April 2007

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00160082.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing