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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 October 2021 |
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Main ID: |
EUCTR2008-001999-67-ES |
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Date of registration:
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17/11/2008 |
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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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Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple
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A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis
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Scientific title:
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Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple
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A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis |
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Date of first enrolment:
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30/01/2009 |
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Target sample size:
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368 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001999-67 |
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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: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Finland
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France
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Germany
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS AND walking disability due to MS (untreated or treated with a stable regimen of a marketed compound for treatment of MS, limited to beta interferons or glatiramer acetate). MS type (relapsing-remitting, secondary progressive, primary progressive, or progressive relapsing) will be determined by the Investigator based on the AAN Practice Guidelines and Tools (http://www.aan.com/go/practice/guidelines) and reference 1 provided in the protocol.
2. Signed Informed Consent form
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Methodology-related
1. Patient who is able to walk 25 feet in less than 8 seconds or subject who takes more than 45 seconds (for any of the 2 allowed trials) to walk 25 feet with or without an assistive device during the T25-FW assessment at V1-V4 (before randomization). Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
2. Multiple sclerosis exacerbation or clinical relapse within 6 months prior to the screening visit (V1) or change in regimen or type of MS treatment during the last 3 months, or start of MS disease-modifying therapies within the 3 months prior to screening.
3. Age <18 years
4. Patients who participated in any previous nerispirdine (HP184) trials
5. Patients who were previously exposed to 3,4-diaminopyridine or 4-aminopyridine (4-AP, fampridine, Fampridine-SR)
6. Patients with current active psychiatric disorders including but not limited to active psychosis, exacerbation of schizophrenia, bipolar disorder, obsessive-compulsive disorder, major depressive disorder, anxiety disorder, and alcohol or substance abuse or dependence (except nicotine)
7. Use of any investigational drug within 30 days or 5 half-lives whichever is longer
8. Patient is the Investigator or any Subinvestigator, Research Assistant, Pharmacist, Study Coordinator, other staff or relative thereof directly involved in the conduct of the protocol/study
9. Patients who are unable to participate for the entire duration of the study, or in the opinion of the Investigator, are likely to be non-compliant with the obligations inherent in the clinical trial participation
10. Any clinically meaningful or unexplained laboratory abnormality(ies); clinically significant or unstable condition(s) or comorbidities; acute or chronically progressive medical or surgical disorder(s) other than MS which may interfere with walking and may affect patient safety (see Appendix L of the protocol)
Patients with confirmed neutropenia (neutrophils < 1500/mm3 or according to ethnic group), thrombocytopenia (platelets < 100 000/ mm3), increase in aminotransferases (either ALT [SGPT] or AST [SGOT] >3 ULN and CPK normal) or creatinine clearance < 50 mL/min cannot be randomized (see Appendix L specifying criteria for discontinuation of IP).
-Nerispirdine-related based on current knowledge on the compound
11. Criteria to reduce reproductive risk:
Breastfeeding and pregnant females cannot be included in a clinical study testing nerispirdine. Male subjects who are sexually active with a pregnant female should not participate in the study. Also, patients wishing to breastfeed or parent a child during the course of the study must not participate.
Women of childbearing potential (WOCBP) as defined in the protocol or male patients not using an effective contraceptive method as described in the protocol cannot be included in clinical studies testing nerispirdine. Women of childbearing potential, who are unwilling to or unable to be tested for pregnancy at study entry and at each clinic visit, or who experience an unexpected delay of menses cannot participate in the study. The pregnancy test to be used in this study is a serum pregnancy test (?-HCG), and not an urine pregnancy test. This test will be performed at each visit.
If, during any nerispirdine study, a female subject becomes pregnant or decides to attempt to become pregnant or if a male subject decides to attempt to father a child, then she or he must stop the study drug immediately. If
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Esclerosis Múltiple
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Multiple Sclerosis
MedDRA version: 11.0
Level: LLT
Classification code 10028245
Term:
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Intervention(s)
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Product Name: Nerispirdine hydrochloride
Product Code: HP184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Nerispirdine hydrochloride
CAS Number: 119229-64-0
Current Sponsor code: HP184
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: ?To assess other measures of efficacy such as the MSWS-12, MFIS, LEMMT, MAS, SGI, and CGI
?To assess the safety and tolerability of nerispirdine
?To evaluate the pharmacokinetic (PK) parameters of nerispirdine and its active metabolite, HP183
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Main Objective: The primary objective is to assess the activity of nerispirdine in improving ability to walk, defined as a consistent improvement in walking speed as measured by the Timed 25-Foot Walk (T25-FW) in patients with MS.
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Primary end point(s): ? Responder criterion, based on consistency of improved response in walking speed on the T25-FW
A responder is defined as one whose last T25-FW measurement on-treatment and at least 2 other T25-FW measurement on-treatment are faster than the fastest speed recorded during any of the 3 ?off drug? visits V2 to V4 before double-blind treatment and the 1 at the end of the 2-week placebo run-out period. All other randomized patients are defined as non-responders.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/01/2009
Contact:
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