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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01423110 |
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Date of registration:
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12/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
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Scientific title:
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A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01423110 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body
Myositis
Exclusion Criteria:
- Unable to walk at least 3 meters without assistance from another person
- Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or
intravenous gamma globulin in the last 6 months
- patients with a history or presence of renal impairment and/or liver disease
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sporadic Inclusion Body Myositis
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Intervention(s)
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Biological: Placebo
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Biological: BYM338
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Primary Outcome(s)
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Effect of BYM338 on Thigh Muscle Volume by MRI
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Effect of BYM338 on muscle function by 'Timed Get Up and Go' test
[Time Frame: 8 weeks]
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Secondary ID(s)
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CBYM338X2205
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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