CompletedPhase 2

A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study

United States160 participantsStarted 2015-07-22

Plain-language summary

This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.

Who can participate

Age range70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criterion: \- Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202) Exclusion criterion: \- Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)

What they're measuring

Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49

Timeframe: Week 49

Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49

Timeframe: Week 49

Trial details

NCT IDNCT02468674

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-03

Results submitted2019-10-24

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