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

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ClinicalTrials.gov Identifier: NCT02468674
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A 24-week off drug extension parallel group study assessing the 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

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: bimagrumab Drug: Placebo Phase 2

Detailed Description:
The primary objective is to assess the durability of effect of bimagrumab (BYM338) as measured by the short physical performance battery (SPPB) total score at week 49.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week Off Drug Extension Parallel Group Study Assessing the 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
Actual Study Start Date : July 22, 2015
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Arm Intervention/treatment
Follow-up (arm 1)
All subjects enter an off-drug follow-up until Week 49.
Drug: bimagrumab

bimagrumab low dose bimagrumab moderate dose bimagrumab high dose

Bimagrumab was administered as an intravenous infusion starting on Day 1 until week 25 in the core study. No intervention in the extension study.


Follow-up (arm 2)
All subjects enter an off-drug follow-up until Week 49.
Drug: Placebo

Placebo

Placebo was administered as intravenous infusion from Day 1 to Week 25 in the core study. No intervention in the extension study.





Primary Outcome Measures :
  1. Short Physical Performance Battery score [ Time Frame: Week 49 ]
    Balance test, gait speed test and chair rise test each yielding a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).


Secondary Outcome Measures :
  1. 6-minute walking distance [ Time Frame: Weeks 25, 37, 49 ]
    Total distance walked during a 6 minute time period expressed in meters

  2. Gait speed [ Time Frame: Weeks 25, 37, 49 ]
    Speed of habitual walking over a 4 meter distance in m/sec

  3. Total lean body mass measured by dual energy X-ray absorptiometry (DXA) [ Time Frame: Weeks 25, 37, 49 ]
    Weight of lean mass of the total body

  4. Appendicular skeletal muscle index measured by DXA [ Time Frame: Weeks 25, 37, 49 ]
    The sum of legs and arms expressed in kilograms (kg)



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468674


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Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02468674     History of Changes
Other Study ID Numbers: CBYM338E2202E1
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sarcopenia, muscle wasting, elderly, strength, physical
function, lean body mass, gait speed

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs