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

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02468674
Phase
PHASE2
Status
Completed

Conditions

  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bimagrumab — DRUG
    bimagrumab low dose bimagrumab moderate dose bimagrumab high dose Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
  • Placebo — DRUG
    Placebo Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.

Study Details

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.

Key Dates

Start date
Jul 22, 2015
Status verified
Jun 2020
Primary completion
Dec 3, 2018
Completion
Dec 3, 2018

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Follow-up (arm 1)
    Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
  • No Intervention: Follow-up (arm 2)
    Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.

Primary Outcome Measure

Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 [ Time Frame: Week 49 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteMiami LakesFlorida33014-
Novartis Investigative SiteGainesvilleGeorgia30501-
Novartis Investigative SiteSpartanburgSouth Carolina29303-
Novartis Investigative SiteSan AntonioTexas78229-
Novartis Investigative SiteMadisonWisconsin53705-

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By research site
Novartis Investigative Site· Miami Lakes, FLNovartis Investigative Site· Gainesville, GANovartis Investigative Site· Spartanburg, SCNovartis Investigative Site· San Antonio, TXNovartis Investigative Site· Madison, WI

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