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Trial record 1 of 2 for:    ALLEGRO laquinimod
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Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) (ALLEGRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509145
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : February 20, 2012
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Laquinimod Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Relapse Rate: Number of confirmed relapses during the double blind study period. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Accumulation of physical disability measured by the time to confirmed progression of EDSS during the study period. [ Time Frame: 24 months ]
  2. MRI Outcomes [ Time Frame: 12, 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509145

Sponsors and Collaborators
Teva Pharmaceutical Industries
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Principal Investigator: Giancarlo Comi U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT00509145    
Other Study ID Numbers: MS-LAQ-301
EUDRACT 2007-003226-19
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases