NCT01844232

Brief Summary

Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 multiple-sclerosis

Timeline
Completed

Started Apr 2013

Geographic Reach
3 countries

35 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

Study Start

First participant enrolled

April 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 25, 2022

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

April 24, 2013

Last Update Submit

April 21, 2022

Conditions

Multiple SclerosisSpasticity

Keywords

Multiple sclerosisspasticityarbaclofen

Outcome Measures

Primary Outcomes (1)

  • Assessment of Adverse Events

    Determination of incidence and severity of Adverse Events (AEs), discontinuations due to AEs and discontinuations due to failure of AERT to alleviate spasticity

    From the beginning of dose titration to end of study (day 393 of dosing)

Secondary Outcomes (1)

  • Determination of Change in Spasticity by Total Number-transformed Modified Ashworth Scale (TNmAS)

    From baseline (Day1, Visit 2) to end of treatment (Day 393)

Study Arms (1)

Arbaclofen Extended Release (ER) Tablets

EXPERIMENTAL

Arbaclofen Extended Release Tablets, 20 mg/day, 30 mg/day or 40 mg/day

Drug: arbaclofen

Interventions

arbaclofenDRUG

Arbaclofen ER tablets, 20 mg, 30 mg and 40 mg

Also known as: OS440
Arbaclofen Extended Release (ER) Tablets

Eligibility Criteria

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

You may qualify if:

  • Patients (male or female) 18 to 70 years of age, inclusive, at the time of the first dose.
  • Have an established diagnosis (per McDonald 2005 Criteria, of Multiple Sclerosis Appendix C (either relapsing remitting or secondary progressive course), that manifests spasticity.
  • If receiving disease-modifying medications (immunomodulatory treatment), these must have been at a stable dose for at least one (1) months prior to screening, and the subject must be willing to maintain this treatment for the duration of the study.
  • If receiving botulinum toxin must be on a stable treatment regimen (e.g. every 12 weeks).
  • If receiving phenol or alcohol injections, should have been received 60 days before enrolment in the study.
  • Absence of infections and peripheral vascular disease.
  • Have a creatinine clearance, as calculated by Glomerular Filtration Rate using the Modification of Diet in Renal Disease (MDRD) formula , greater than 60 milliliters/minute.
  • Use of a medically highly effective form of birth control during the study and for 90 days thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects. .
  • Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study

You may not qualify if:

  • Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity.
  • Inability to rate their level of spasticity or distinguish it from other MS symptoms.
  • History of allergy to baclofen.
  • Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables (Appendix D Prohibited Concomitant Medications)
  • Pregnancy, lactation or planned pregnancy during the course of the study and for three months thereafter. (Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test at baseline).
  • History of, or current unstable psychiatric disease, or signs and symptoms of significant medical disorders such as severe, progressive, or uncontrolled renal, hepatic, gastrointestinal, hematological, endocrine, immunologic, pulmonary, cardiac or neurological disease which, in the opinion of the investigator, may; put the subject at risk because of participation, influence the result of the study, or affect the subject's ability to participate.
  • Seizures requiring medication.
  • Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression.
  • Subjects with abnormal micturition that requires indwelling or intermittent catheterization or with lower urinary tract symptoms (LUTS) that result in a score greater than twenty-six (\>26) in the Baseline Urinary Symptom Profile© questionnaire.
  • Current malignancy or history of malignancy that has not been in remission for more than five years, except effectively treated basal cell skin carcinoma.
  • History of substance abuse within the past twelve (12) months.
  • Participation in another interventional research study within thirty (30) days of Screening except OS440-3002.
  • Patients who are uncooperative or unwilling to sign consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Osmotica Study Site-154

Gilbert, Arizona, 85234, United States

Location

Osmotica Study Site-158

Phoenix, Arizona, 85032, United States

Location

Osmotica Study Site-165

Pasadena, California, 91105, United States

Location

Osmotica Study Site-164

Torrance, California, 90505, United States

Location

Osomtica Study Site-164

Torrance, California, 90505, United States

Location

Osmotica Study Site-173

Bradenton, Florida, 34205, United States

Location

Osmotica Study Site-178

Pompano Beach, Florida, 33060, United States

Location

Osmotica Study Site-170

Tampa, Florida, 33606, United States

Location

Osmotica Study Site-179

Northbrook, Illinois, 60096, United States

Location

Osmotica Study Site-174

Lenexa, Kansas, 66214, United States

Location

Osmotica Study Site-175

Ann Arbor, Michigan, 48104, United States

Location

Osmotica Study Site-161

Plainview, New York, 11803, United States

Location

Osmotica Study Site-151

Charlotte, North Carolina, 28203, United States

Location

Osmotica Study Site-157

High Point, North Carolina, 27262, United States

Location

Osmotica Study Site-155

Raleigh, North Carolina, 27607, United States

Location

Osmotica Study Site-152

Wilmington, North Carolina, 28401, United States

Location

Osmotica Study Site-156

Dayton, Ohio, 45417, United States

Location

Osmotica Study Site-163

Philadelphia, Pennsylvania, 19107, United States

Location

Osmotica Study Site-162

Franklin, Tennessee, 37064, United States

Location

Osmotica Study Site-171

San Antonio, Texas, 78229, United States

Location

Osmotica Study Site-166

Vienna, Virginia, 22182, United States

Location

Osmotica Study Site-554

Krasnoyarsk, 660022, Russia

Location

Osmotica Study Site-552

Krasnoyarsk, Russia

Location

Osmotica Study Site-557

Moscow, 107150, Russia

Location

Osmotica Study Site-556

Moscow, 127018, Russia

Location

Osmotica Study Site-553

Pyatigorsk, Russia

Location

Osmotica Study Site-551

Saint Petersburg, 190000, Russia

Location

Osmotica Study Site-560

Sestroretsk, 197706, Russia

Location

Osmotica Study Site-555

Tonnel’nyy, 357034, Russia

Location

Osmotica Study Site-653

Dnipropetrovsk, 49022, Ukraine

Location

Osmotica Study Site-655

Dnipropetrovsk, 53012, Ukraine

Location

Osmotica Study Site-651

Donetsk, 83003, Ukraine

Location

Osmotica Study Site-654

Kharkiv, 61103, Ukraine

Location

Osmotica Study Site-656

Lviv, 79010, Ukraine

Location

Osmotica Study Site-657

Poltava, 36011, Ukraine

Location

MeSH Terms

Conditions

Multiple SclerosisMuscle Spasticity

Interventions

arbaclofen placarbil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Praveen Tyle, Ph.D.

    Osmotica Pharmaceutical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: All subjects will begin treatment with arbaclofen at 20 milligrams (mg) per day (2 X 10 mg) for two weeks, then increase to 30 mg per day (2 X 15 mg) for two weeks, and then increase to 40 mg per day (2 X 20 mg) based on the Dose Escalation Criteria. Once the subject reaches the Maintenance Dose, they will remain on that dose for approximately 1 year. The Maintenance Dose is the highest tolerated dose, not to exceed 40 mg per day.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 1, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

April 25, 2022

Record last verified: 2015-05

Locations

RU(8)US(21)UA(6)