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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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EUCTR |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
EUCTR2017-002599-15-DK |
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Date of registration:
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07/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis.
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Scientific title:
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Effect of pyridostigmine (Mestinon®) on muscle strength in Myasthenia Gravis. |
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Date of first enrolment:
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07/11/2017 |
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Target sample size:
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32 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002599-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jan L. S. Thomsen
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Address:
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Nørrebrogade 44, 3. sal
8000
Aarhus C
Denmark |
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Telephone:
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Email:
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jathms@rm.dk |
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Affiliation:
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Aarhus University |
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Name:
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Jan L. S. Thomsen
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Address:
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Nørrebrogade 44, 3. sal
8000
Aarhus C
Denmark |
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Telephone:
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Email:
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jathms@rm.dk |
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Affiliation:
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Aarhus University |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Acetylcholine-receptor antibody positive Myasthenia Gravis, Age 18-90 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion criteria:
Cardio-pulmonary disease, neuropathy, myopathy, malignant disease, pregnancy or breastfeeding
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis
MedDRA version: 20.0
Level: HLT
Classification code 10071942
Term: Myasthenia gravis and related conditions
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Trade Name: Mestinon
Pharmaceutical Form: Capsule
INN or Proposed INN: pyridostigmine
CAS Number: 155-97-5
Other descriptive name: PYRIDOSTIGMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Before and after administration, and during follow-up (3 months).
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Primary end point(s): Change on clinical rating scales
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Secondary Objective: Not applicable.
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Main Objective: To evaluate and quantify the effect of pyridostigmine (Mestinon) on symptoms and motor performance in patients with Myasthenia Gravis in a randomized, double-blinded and placebo-controlled study.
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Secondary Outcome(s)
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Secondary end point(s): Change in force measured with dynamometry.
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Timepoint(s) of evaluation of this end point: Before and after administration, and during follow-up (3 months).
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Source(s) of Monetary Support
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Aarhus University
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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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