Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00509145
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE July 27, 2007
First Posted Date  ICMJE July 31, 2007
Last Update Posted Date February 20, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
Relapse Rate: Number of confirmed relapses during the double blind study period. [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00509145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • Accumulation of physical disability measured by the time to confirmed progression of EDSS during the study period. [ Time Frame: 24 months ]
  • MRI Outcomes [ Time Frame: 12, 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Laquinimod
    Laquinimod 0.6 mg capsule, oral, once daily
    Other Name: TV-5600
  • Other: Placebo
    oral, once daily, capsule
Study Arms  ICMJE
  • Experimental: Laquinimod
    Laquinimod 0.6 mg, oral
    Intervention: Drug: Laquinimod
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2012)
1106
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2007)
1000
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Bulgaria,   Canada,   Czech Republic,   Estonia,   Former Serbia and Montenegro,   France,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00509145
Other Study ID Numbers  ICMJE MS-LAQ-301
EUDRACT 2007-003226-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giancarlo Comi U.O.Neurology-Neurorehabilitation and Clinical Neurophysiology
PRS Account Teva Pharmaceutical Industries
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP