- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027391
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
March 24, 2015 updated by: FDA Office of Orphan Products Development
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD.
It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone.
Treatment will continue for 52 weeks unless unacceptable side effects occur.
Patients will undergo testing of muscle function.
All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.
Study Type
Interventional
Enrollment
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
- Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
- Weakness of scapular stabilizers or foot dorsiflexors
- Ambulatory
- Weakness grade 2 or worse in the arm using upper extremity grading scale
Exclusion criteria:
- Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
- Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
- Pregnancy
- Known hypersensitivity to anabolic steroids
- Any medical or psychological condition that would interfere with the study
- Requirement for a wheelchair
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John T. Kissel, M.D., Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion
December 7, 2022
Study Completion
August 1, 2004
Study Registration Dates
First Submitted
December 5, 2001
First Submitted That Met QC Criteria
December 6, 2001
First Posted (Estimate)
December 7, 2001
Study Record Updates
Last Update Posted (Estimate)
March 25, 2015
Last Update Submitted That Met QC Criteria
March 24, 2015
Last Verified
November 1, 2001
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- Muscular Dystrophies
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Androgens
- Anabolic Agents
- Albuterol
- Oxandrolone
Other Study ID Numbers
- FD-R-2029-01
- FD-R-002029-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscular Dystrophies
-
Assistance Publique - Hôpitaux de ParisRecruitingLimb Girdle Muscular DystrophiesFrance
-
aTyr Pharma, Inc.CompletedLimb-Girdle Muscular Dystrophies | Facioscapulohumeral Muscular DystrophyUnited States, Denmark, France
-
Wake Forest University Health SciencesMuscular Dystrophy AssociationCompletedMuscular Dystrophies, Limb-Girdle (GENETICALLY CONFIRMED)United States
-
Virginia Commonwealth UniversityWashington University School of Medicine; University of Iowa; University of Minnesota and other collaboratorsRecruitingMuscular Dystrophies | Limb Girdle Muscular DystrophyUnited States, United Kingdom
-
Sarepta Therapeutics, Inc.Active, not recruiting
-
ML Bio Solutions, Inc.Virginia Commonwealth UniversityCompletedMuscular Dystrophies | Limb Girdle Muscular DystrophyUnited States, Denmark
-
Neurogen Brain and Spine InstituteWithdrawn
-
Rigshospitalet, DenmarkRecruitingLimb Girdle Muscular DystrophyDenmark
-
Sarepta Therapeutics, Inc.RecruitingLimb-girdle Muscular DystrophyUnited States
-
Rigshospitalet, DenmarkCompleted
Clinical Trials on Albuterol
-
Amphastar Pharmaceuticals, Inc.TerminatedSingle-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced BronchoconstrictionAsthma | BronchospasmUnited States
-
Pennington Biomedical Research CenterCompletedHealthy VolunteersUnited States
-
Concentrx Pharmaceuticals, Inc.PharPoint Research, Inc.; Kramer Consulting, LLCCompleted
-
Children's Hospital of PhiladelphiaSunovionCompleted
-
Intech Biopharm Ltd.Recruiting
-
Amphastar Pharmaceuticals, Inc.Terminated
-
Amphastar Pharmaceuticals, Inc.Completed
-
SunovionCompleted