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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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30 June 2019 |
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Main ID: |
EUCTR2014-001579-30-GB |
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Date of registration:
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08/09/2014 |
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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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A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as
compared to placebo
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Scientific title:
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A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO |
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Date of first enrolment:
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27/11/2014 |
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Target sample size:
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375 |
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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:2014-001579-30 |
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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
Number of treatment arms in the trial: 3
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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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Canada
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Germany
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Italy
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Netherlands
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Poland
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Russian Federation
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Graf Arco Str. 3
89079
Ulm
Germany |
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Telephone:
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Email:
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Info-era-clinical@teva.de |
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Affiliation:
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Teva GmbH |
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Name:
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Clinical Trial Information Desk
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Address:
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Graf Arco Str. 3
89079
Ulm
Germany |
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Telephone:
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Email:
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Info-era-clinical@teva.de |
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Affiliation:
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Teva GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients must have a confirmed and documented PPMS diagnosis as defined by the current valid McDonald criteria
2. Baseline magnetic resonance imaging (MRI) showing lesions consistent with PPMS in either or both brain and spinal cord
3. Patients must have an Expanded Disability Status Scale (EDSS) score of 3 to 6.5, inclusive, at both
screening and baseline visits
4. Documented evidence of clinical disability progression in the 2 years prior to screening.
5. Functional System Score (FSS) of > or equal 2 for the pyramidal system or gait impairment due to lower extremity dysfunction
6. Patients must be between 25 to 55 years of age, inclusive
7. Women of child-bearing potential must practice an acceptable method of birth control for 30 days before taking the study drug, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment is administered.
8. Patients must sign and date a written informed consent prior to entering the study.
9. Patients must be willing and able to comply with the protocol requirements for the duration of the study.
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 375
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients with history of any multiple sclerosis (MS) exacerbations or relapses, including any episodes of optic neuritis.
2. Progressive neurological disorder other than PPMS.
3. Any MRI record showing presence of cervical cord compression.
4. Baseline MRI showing other findings (including lesions that are atypical for PPMS) that may explain the clinical signs and symptoms.
5. Relevant history of vitamin B12 deficiency.
6. Positive human T-lymphotropic virus Type I and II (HTLV-I/II) serology.
7. Use of experimental or investigational drugs in a clinical study within 24 weeks prior to baseline. Use of a currently marketed drug in a clinical study within 24 weeks prior to baseline would not be exclusionary, provided no other exclusion criteria are met.
8. Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azathioprine within 48 weeks prior to baseline.
9. Previous treatment with fingolimod (GILENYA®, Novartis), dimethyl fumarate (TECFIDERA®, Biogen Idec Inc), glatiramer acetate (COPAXONE®, Teva), interferon-ß (either 1a or 1b), intravenous immunoglobulin, or plasmapheresis within 8 weeks prior to baseline.
10. Use of teriflunomide (AUBAGIO®, Sanofi) within 2 years prior to baseline, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to baseline.
11. Prior use of monoclonal antibodies ever, except for:
a. natalizumab (TYSABRI®, Biogen Idec Inc), if given more than 24 weeks prior to baseline AND the patient is John Cunningham (JC) virus antibody test negative (as per medical history)
b. rituximab, ocrelizumab, or ofatumumab, if B cell count (CD19, as per medical history) is higher than 80 cells/µL
12. Use of mitoxantrone (NOVANTRONE®, Immunex) within 5 years prior to screening. Use of mitoxantrone >5 years before screening is allowed in patients with normal ejection fraction and who did not exceed the total lifetime maximal dose.
13. Previous use of laquinimod.
14. Chronic (eg, more than 30 consecutive days or monthly dosing, with the intent of MS disease modification) systemic (intravenous, intramuscular or oral) corticosteroid treatment within 8 weeks prior to baseline.
15. Previous use of cladribine or alemtuzumab (LEMTRADA®, Sanofi).
16. Previous total body irradiation or total lymphoid irradiation.
17. Previous stem cell treatment, cell-based treatment, or bone marrow transplantation of any kind.
18. Patients who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) within 12 weeks prior to baseline.
19. Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to baseline.
20. Use of inducers of CYP3A4 within 2 weeks prior to baseline.
21. Pregnancy or breastfeeding.
22. Serum levels =3× upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening.
23. Serum direct bilirubin which is =2×ULN at screening.
24. Patients with a clinically significant or unstable medical or surgical condi
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Primary Progressive Multiple Sclerosis
MedDRA version: 19.0
Level: PT
Classification code 10063401
Term: Primary progressive multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: Laquinimod
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LAQUINIMOD
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Laquinimod
Product Code: TV-5600
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LAQUINIMOD
CAS Number: 248282-07-7
Current Sponsor code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
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Primary Outcome(s)
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Main Objective: The objectives of this study are to assess the efficacy, safety, and tolerability of a once daily oral dose of laquinimod (0.6 or 1.5 mg) compared to placebo in PPMS patients.
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Timepoint(s) of evaluation of this end point: Percentage in Brain Volume Change (PBVC) from baseline to week 48
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Primary end point(s): Brain atrophy (BA), defined as change in brain volume
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Secondary Objective: Not applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: -Time to confirmed disability progression (CDP), to be confirmed after at least 12 weeks
-An increase from baseline in EDSS score confirmed after at least 12 weeks
-An increase of at least 20% from baseline in T25FW score, confirmed after at least 12 weeks
-The number of new T2 brain lesions at week 48
-Change from baseline to week 48 in the T25FW score
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Secondary end point(s): - Time to CDP (confirmed disability progression) defined by an increase in baseline EDSS
- Time to CDP defined by an increase in baseline EDSS or at least a 20% worsening in the Timed 25 Foot Walk
- The number of new T2 brain lesions
- Change from baseline in the T25FW score
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Secondary ID(s)
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TV5600-CNS-20006
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Source(s) of Monetary Support
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Teva Pharmaceutical Industries Ltd
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Ethics review
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Status: Approved
Approval date:
Contact:
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