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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00541216 |
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Date of registration:
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07/10/2007 |
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Primary sponsor: |
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Public title:
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Ephedrine for the Treatment of Congenital Myasthenia
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Scientific title:
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Date of first enrolment:
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October 2007 |
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Target sample size:
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15 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00541216 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Simon Edvardson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patients , with congenital myasthenia, belonging to a previously
reported kindred diagnosed with COLQ deficiency.
Exclusion Criteria:
- History of allergy to Ephedrine or any inactive component.
- Significant abnormalities in screening Cardiovascular parameters (blood pressure,
pulse).
- Surgery within 6 weeks of screening.
- Concurrent use of any other medication except steroids.
- Pregnancy.
- Thyrotoxicosis.
- Co-morbid conditions or other neurological disorders that would confound assessment
of clinical parameters.
- Participation in another clinical trial within 30 days of study start.
- Patients who are non-cooperative or parents/ legal guardians who are unwilling to
sign consent form.
Age minimum:
12 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myasthenic Syndromes, Congenital
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Intervention(s)
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Drug: Ephedrine
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Primary Outcome(s)
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strength and fatiguability: walking, straight arm raising, spirometry.
[Time Frame: 5 weeks]
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Secondary ID(s)
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ephedrine-hmo-ctil
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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