Clinical trial NCT02468674: A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
Official title: A 24 Week Off Drug Extension, Parallel Group, Study Assessing Durability of Effect on Skeletal Muscle Strength and Function Following a 6-month Double-blind, Placebo Controlled Study Evaluating Bimagrumab in Older Adults With Sarcopenia (InvestiGAIT Extension)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcopenia
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 160
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Two populations were defined as below:

* Population I: Patients enrolled prior to the protocol amendment 1, who received bimagrumab 70 mg, 210 mg or 700 mg in the core study, were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Patients receiving placebo in the core study continued receiving placebo in the extension study.
* Population II: Patients enrolled after protocol amendment 1, who received bimagrumab 700 mg or placebo in the core study, did not receive study medication in the extension study and were followed-up per schedule defined in this protocol amendment.

Eligibility criteria: 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)

Primary outcomes:
measure: Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
timeFrame: Week 49
measure: Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
timeFrame: Week 49
Secondary outcomes:
measure: Population I: 6-minute Walking Distance (6MWT) at Week 49
timeFrame: Week 49
measure: Population II: 6-minute Walking Distance (6MWT) at Week 49
timeFrame: Week 49
measure: Population I: Gait Speed at Week 49
timeFrame: Week 49
measure: Population II: Gait Speed at Week 49
timeFrame: Week 49
measure: Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
timeFrame: Week 49
measure: Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
timeFrame: Week 49
measure: Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
timeFrame: Week 49
measure: Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
timeFrame: Week 49
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Novartis Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: St Albans
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen NV
country: Denmark
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Obu-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Mizunami-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Nara-city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Kawachinagano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kitaadachigun Inamachi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kitamoto-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Itabashi ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Suwon si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Getafe
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Genève 14
country: Switzerland
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: