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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: |
NCT02280096 |
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Date of registration:
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10/10/2014 |
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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 and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis
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Scientific title:
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Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02280096 |
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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: Triple (Participant, 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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Mexico
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Contacts
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Name:
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Claudia Arreola Mora, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Name:
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Israel Grijalva, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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Inclusion Criteria: Patients with multiple sclerosis (MS) are eligible for the study if
they meet the following criteria:
1. Relapsing recurrent MS with an evolution of at last 6 months before the study began.
2. Both males and females, aged 20 - 65 years
3. Neurologic Expanded Disability Status Scale (EDSS) 3 - 7
4. Who are in first-line immunomodulatory therapy and have a stable disease
5. No more than one outbreak per year.
6. The absence of antiepileptic antecedent and electroencephalogram without epileptic
activity.
7. For females: postmenopausal or surgically sterile, or using an acceptable method of
birth control
Exclusion Criteria:
1. History of cardiovascular disease (syncope, arrhythmia, or myocardial infarction
within the last two years), systolic blood pressure greater than 150 or less than 70
mm Hg, diastolic blood pressure greater than 110 or less than 50 mm Hg, or heart rate
greater than 110 or less than 50 beats/minute; impaired hepatic function (total
hepatic enzyme or bilirubin levels greater than 2 times the upper limits of normal) or
impaired renal function (creatinine level greater than 2 times the upper limits of
normal) less than 6 months before the study
2. Known allergy to pyridine-containing drugs
3. Neurologic, degenerative, or psychiatric disorders that would impair the patient's
ability to complete the protocol
4. Any illness or abnormality that would jeopardize patient safety or interfere with the
conduct of the study
5. History of substance abuse
6. Inability to discontinue excluded concomitant drug therapy
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: 4-aminopyridine
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Primary Outcome(s)
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The Brief Repeatable Battery of Rao
[Time Frame: 10-15 minutes]
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Color Trails Test (CTT)
[Time Frame: 5-8 minutes]
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Five Digit Test (FDT). Processing Speed
[Time Frame: 8-10 min]
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Integrated Program of Neuropsychological Exploration Test Barcelona
[Time Frame: 7-10 min]
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Tower Of London (TOL). Execution Time and Problem-solving Time
[Time Frame: 25-30 minutes]
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Tower Of London (TOL). Total Moves and Total Correct Moves
[Time Frame: 25-30 minutes]
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Wisconsin Card Sorting Test (WCST)
[Time Frame: 10-15 minutes]
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Rey-Osterrieth Complex Figure Test (ROCF)
[Time Frame: 10-15 minutes]
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Secondary Outcome(s)
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Fatigue
[Time Frame: 10 minutes]
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Improved Physical Capacity
[Time Frame: 15-20 minutes]
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Number of Participants With Abnormal Studies
[Time Frame: 22 weeks]
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Walk
[Time Frame: 5-10 minutes]
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Secondary ID(s)
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2012-785-091
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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