The PROPEL Trial

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Principal investigator Oslo site and National coordinator Norway:

Svein O. Fredwall, Medical Doctor, PhD

Abstract

This is a long-term, multi-center, observational study in children 2.5 to <17 years with achondroplasia (ACH). The objective is to evaluate growth, ACH-related medical complications, assessments of health-related quality of life, body pain, functional abilities, cognitive functions, and treatments of study participants. No study medication will be administered. After a minimum of 6 months of participation, participants will have the opportunity to enroll in a QED-sponsored interventional study (PROPEL 3) to treat achondroplasia.

ClinicalTrials.gov ID: NCT04035811

Per-Kristian Knudsen (sub-investigator), MD, PhD, Pediatric Clinical research Unit, Oslo University Hospital, Rikshospitalet

Line Samuelsen, study coordinator, Pediatric Clinical research Unit, Oslo University Hospital, Rikshospitalet

Charlotte Holst-Hansen, study nurse, Pediatric Clinical research Unit, Oslo University Hospital, Rikshospitalet

Thu Huong Pham, study nurse, Pediatric Clinical research Unit, Oslo University Hospital, Rikshospitalet

Ethical approvals

REK (application number 599002)

Data protection officer Oslo University Hospital: application number 23/14222

Funding

Industry-sponsored

Time period

August 2023 to January 2030