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Trial record 2 of 2 for:    MS-LAQ-301

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) (ALLEGRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00509145
First received: July 27, 2007
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).


Condition Intervention Phase
Multiple Sclerosis
Drug: Laquinimod
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Relapse Rate: Number of confirmed relapses during the double blind study period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accumulation of physical disability measured by the time to confirmed progression of EDSS during the study period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • MRI Outcomes [ Time Frame: 12, 24 months ] [ Designated as safety issue: No ]

Enrollment: 1106
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laquinimod
Laquinimod 0.6 mg, oral
Drug: Laquinimod
Laquinimod 0.6 mg capsule, oral, once daily
Other Name: TV-5600
Placebo Comparator: Placebo
Matching placebo
Other: Placebo
oral, once daily, capsule
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
  2. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5.
  3. Subjects must be in a stable neurological condition and free of corticosteroid treatment [intravenous (iv), intramuscular (im) and/or per os (po)] 30 days prior to screening (month -1).
  4. Subjects must have had experienced one of the following:

    • At least one documented relapse in the 12 months prior to screening
    • At least two documented relapses in the 24 months prior to screening
    • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
  5. Subjects must be between 18 and 55 years of age, inclusive.
  6. Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening.
  7. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide).
  8. Subjects must be able to sign and date a written informed consent prior to entering the study
  9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

  1. Subjects with progressive forms of MS
  2. An onset of relapse, unstable neurological condition or any treatment with corticosteroids [intravenous (iv), intramuscular (im) and/or per os (po)] or ACTH between month -1 (screening) and 0 (baseline).
  3. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  4. Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
  5. Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod.
  6. Previous treatment with glatiramer acetate (Copaxone®) Interferon-β (either 1a or 1b) or IVIG within 2 months prior to screening visit.
  7. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
  8. Previous total body irradiation or total lymphoid irradiation.
  9. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  10. A known history of tuberculosis.
  11. Acute infection two weeks prior to baseline visit.
  12. Major trauma or surgery two weeks prior to baseline
  13. A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
  14. A carrier state of factor V Leiden mutation (either homo- or heterozygous) as disclosed at screening.
  15. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
  16. Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine) see detailed list in Appendix 5
  17. Use of amiodarone within 2 years prior to screening visit.
  18. Pregnancy or breastfeeding.
  19. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:

    • A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
    • A gastrointestinal disorder that may affect the absorption of study medication.
    • Renal or metabolic diseases.
    • Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
    • A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin
    • A QTC interval (obtained from either 2 ECG recordings at screening or from the mean value calculated from 3 measurements at baseline visit) which is >450msec.
    • A family history of Long- QT syndrome.
    • A history of drug and/or alcohol abuse.
    • Major psychiatric disorder.
  20. A known history of sensitivity to Gd.
  21. Inability to successfully undergo MRI scanning.
  22. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.

Exclusion Criteria:

  1. Subjects who suffer from any form of progressive MS.
  2. Any condition which the investigator feels may interfere with participation in the study.
  3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
  4. Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  5. Previous treatment with immunomodulators within two months prior to screening
  6. Pregnancy or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509145

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Giancarlo Comi U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00509145     History of Changes
Other Study ID Numbers: MS-LAQ-301, EUDRACT 2007-003226-19
Study First Received: July 27, 2007
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
European Union: European Medicines Agency
France: Ministry of Health
Georgia: Ministry of Health
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Bulgaria: Ministry of Health
Spain: Ministry of Health
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Teva Pharmaceutical Industries:
Relapsing
Remitting

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014