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Trial record 4 of 6 for:    MS and arbaclofen

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (OS440-3004)

This study is not yet open for participant recruitment.
Verified September 2017 by Osmotica Pharmaceutical US LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03290131
First Posted: September 21, 2017
Last Update Posted: September 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Osmotica Pharmaceutical US LLC
  Purpose
Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.

Condition Intervention Phase
Multiple Sclerosis Spasticity, Muscle Drug: Arbaclofen Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Osmotica Pharmaceutical US LLC:

Primary Outcome Measures:
  • total numeric-transformed modified Ashworth Scale score of the most affected limb (TNmAS-MAL) [ Time Frame: 84 days ]
    The TNmAS is considered the primary clinical measure of muscle spasticity in subjects with neurological conditions. It is a useful 6-point rating scale to measure abnormality in tone or the resistance to passive movements

  • Clinical Global Impression of Change (CGIC) [ Time Frame: 84 days ]
    The CGIC was developed for use in National Institute of Mental Health (NIMH)-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the subject's global functioning prior to and after initiating a study medication. The CGIC scale will be used to measure the overall change in the subject's condition since starting the study.


Estimated Enrollment: 510
Anticipated Study Start Date: December 28, 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AERT 40 mg
40 mg Arbaclofen Extended-Release Tablets
Drug: Arbaclofen
Arbaclofen is the active R enantiomer of baclofen.
Active Comparator: AERT 80 mg
80 mg Arbaclofen Extended-Release Tablets
Drug: Arbaclofen
Arbaclofen is the active R enantiomer of baclofen.
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo comparator

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral AERT in MS patients with spasticity. Two doses of AERT, 40 mg and 80 mg, will be compared with placebo. The treatment groups will be randomized in a 1:1:1 ratio. Eligible patients will undergo a washout period for withdrawal of all medications used for anti-spasticity and/or muscle relaxation prior to randomization. A baseline clinical evaluation will be performed (Visit 2) to confirm eligibility for study randomization, and subjects will be randomly assigned to 1 of 3 treatment arms. Subjects will remain on maintenance treatment for approximately 3 months.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Includes:

  • Subjects 18 to 65 years of age, inclusive.
  • An established diagnosis of MS that manifests a documented history of spasticity.
  • If receiving disease-modifying medications (eg, interferons approved for MS, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be willing to maintain this treatment dose for the duration of the study. If receiving AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable dose for at least 3 months prior to Visit 1.
  • Stable regimen for at least 3 months prior to Visit 2 for all medications and non-pharmacological therapies that are intended to alleviate spasticity.
  • Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement.
  • Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects).
  • Willing to sign the informed consent form (ICF).

Exclusion Criteria Includes:

  • Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity.
  • Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables.
  • Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit.
  • Subject has clinically significant abnormal laboratory values, in the opinion of the investigator, at Visit 1 or Visit 2.
  • Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma.
  • Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03290131


Contacts
Contact: Diana Sirico 908-809-1372 dsirico@osmotica.com

Sponsors and Collaborators
Osmotica Pharmaceutical US LLC
Investigators
Study Director: David Jacobs, MD Vice President
  More Information

Responsible Party: Osmotica Pharmaceutical US LLC
ClinicalTrials.gov Identifier: NCT03290131     History of Changes
Other Study ID Numbers: OS440-3004
First Submitted: September 19, 2017
First Posted: September 21, 2017
Last Update Posted: September 21, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms