NCT00326625

Brief Summary

Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2008

Completed
13.4 years until next milestone

Results Posted

Study results publicly available

October 20, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

May 16, 2006

Results QC Date

July 8, 2021

Last Update Submit

August 1, 2022

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R)

    The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported.

    Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52

Secondary Outcomes (1)

  • Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation

    Baseline up to 52 weeks

Study Arms (2)

40 mg glatiramer acetate (GA)

EXPERIMENTAL

Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day.

Drug: 40 mg glatiramer acetate

Placebo

PLACEBO COMPARATOR

Pre-filled syringe of matching placebo, administered subcutaneously once a day.

Drug: Placebo

Interventions

40 mg glatiramer acetateDRUG

parenteral drug

40 mg glatiramer acetate (GA)
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
  • Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
  • Slow VC test equal or greater than 70% of the predicted value.
  • The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
  • Stable dose of riluzole for at least 8 weeks prior to screening.
  • Age - 18-70 (inclusive).

You may not qualify if:

  • The use of invasive or non-invasive ventilation.
  • Subject having undergone gastrostomy.
  • Subject with any clinically significant or unstable medical condition.
  • Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
  • Additional criteria per protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Teva Benelux

Haarlem, Belgium

Location

Teva Benelux

Leuven, Belgium

Location

Teva France

Paris, France

Location

Teva Germany

Mörfelden-Walldorf, Germany

Location

Teva Israel

Tel Aviv, Israel

Location

Teva Italy

Milan, Italy

Location

Teva UK

Aylesbury, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products, R&D Inc.
USMedInfo@tevapharm.com
1-888-483-8279

Study Officials

  • Merav Bassan, PhD.

    Teva Pharmaceuticals Industries LTD

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

July 27, 2006

Primary Completion

June 17, 2008

Study Completion

June 17, 2008

Last Updated

August 3, 2022

Results First Posted

October 20, 2021

Record last verified: 2022-08

Locations

IL(1)FR(1)BE(2)DE(1)IT(1)GB(1)