Muscular DystrophiesNCT00027391
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
A study testing Albuterol and Oxandrolone in people with Muscular Dystrophies, run by FDA Office of Orphan Products Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscular Dystrophies
- What is being tested?
- Albuterol and Oxandrolone
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscular Dystrophies
- Being tested
- Albuterol, Oxandrolone
- Keywords
- Muscle Weakness, Muscular Dystrophy
- Medical subject headings
- Muscular Dystrophies, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuterolDrug
OxandroloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2001 (estimated)
- Study startSep 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DystrophiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Investigators
- John T. Kissel, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027391
- Sponsor's protocol ID
- FD-R-2029-01
- Other IDs
- FD-R-002029-01
- Status last verified
- Nov 2001
- First submitted
- 5 Dec 2001
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
- ClinicalTrials.gov ID
- NCT00027391
- Acronym / sponsor ID
- FD-R-2029-01
- Conditions
- Muscular Dystrophies
- Keywords
- Muscle Weakness, Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Study start
- Sep 2001
- Study completion
- Aug 2004
- First posted
- 7 Dec 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol | Drug | – |
| Oxandrolone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John T. Kissel, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albuterol and Oxandrolone in people with Muscular Dystrophies, run by FDA Office of Orphan Products Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.