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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

Primary Purpose

Spasticity, Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IPX056
Baclofen IR
Placebo IPX056
Placebo IR
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female at least 18 years old.
  • Agrees to use a medically acceptable method of contraception throughout the study
  • Diagnosed with MS as defined by Poser or McDonald Criteria.
  • Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit that has resulted in improved spasticity.
  • Willing to wash out and remain off other antispasticity medications during the study.

Exclusion Criteria:

  • If female, the subject is pregnant, planning to become pregnant, or breastfeeding.
  • History of allergy or severe intolerance to baclofen.
  • Did not respond to previous baclofen treatment in any formulation.
  • Has experienced an exacerbation of MS within 1 month.
  • Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months prior to the study.
  • Subjects with clinically significant impairment of renal function
  • History of active seizure disorder or epilepsy, or currently taking an anticonvulsant for treatment or control of seizure.
  • Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's Disease).
  • Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol or therapeutic alcohol nerve block within 12 months or planned use of these drugs during this study.
  • Has clinically significant limitation of passive range of motion of lower extremities.
  • Has had major surgery within 6 months prior to Screening Visit that may affect spasticity assessments such as abdominal surgery, back surgery, lower leg and knee surgeries.

Sites / Locations

  • Northwest NeuroSpecialists, PLLC
  • University of Colorado
  • Meridien Research
  • Fort Wayne Neurological Center
  • MidAmerica Neuroscience Institute
  • QUEST Research Institute
  • Great Falls Cllinic
  • Empire Neurology, PC
  • Winthrop University Hospital
  • Wake Forest University Health Sciences
  • Central Texas Neurology Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

IPX056-Baclofen IR-IPX056

IPX056-IPX056-Baclofen IR

Arm Description

Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.

Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.

Outcomes

Primary Outcome Measures

Morning Stiffness Score

Secondary Outcome Measures

Full Information

First Posted
June 2, 2009
Last Updated
October 25, 2019
Sponsor
Impax Laboratories, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00914290
Brief Title
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Official Title
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impax Laboratories, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
Detailed Description
IPX056 was compared with commercially available tablets as it was designed to provide a prolonged duration of absorption to reduce dose frequency and/or to provide prolonged duration of antispasticity effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPX056-Baclofen IR-IPX056
Arm Type
Other
Arm Description
Following 2 weeks of run-in period, subjects were randomized to IPX056 and Placebo IR for 2 weeks and then to Baclofen IR and Placebo IPX056 for 2 weeks.
Arm Title
IPX056-IPX056-Baclofen IR
Arm Type
Active Comparator
Arm Description
Following 2 weeks of run-in period, subjects were randomized to Baclofen IR and Placebo IPX056 for 2 weeks and then to IPX056 and Placebo IR for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
IPX056
Other Intervention Name(s)
IPX056 ER Capsule, IPX056 ER
Intervention Description
IPX056 ER capsule containing 10 mg baclofen
Intervention Type
Drug
Intervention Name(s)
Baclofen IR
Other Intervention Name(s)
CAS Registry Number [11134-47-0]
Intervention Description
Encapsulated baclofen tablet 5 mg per capsule
Intervention Type
Drug
Intervention Name(s)
Placebo IPX056
Intervention Description
Placebo capsule for IPX056
Intervention Type
Drug
Intervention Name(s)
Placebo IR
Intervention Description
Placebo encapsulated baclofen placebo tablet
Primary Outcome Measure Information:
Title
Morning Stiffness Score
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years old. Agrees to use a medically acceptable method of contraception throughout the study Diagnosed with MS as defined by Poser or McDonald Criteria. Receiving commercial baclofen tablets at a stable total daily dose ranging from 15 mg to 80 mg in a TID dosing regimen for at least 4 weeks prior to the Screening Visit that has resulted in improved spasticity. Willing to wash out and remain off other antispasticity medications during the study. Exclusion Criteria: If female, the subject is pregnant, planning to become pregnant, or breastfeeding. History of allergy or severe intolerance to baclofen. Did not respond to previous baclofen treatment in any formulation. Has experienced an exacerbation of MS within 1 month. Urinary tract infection (UTI) within 2 weeks or two symptomatic UTIs within 6 months prior to the study. Subjects with clinically significant impairment of renal function History of active seizure disorder or epilepsy, or currently taking an anticonvulsant for treatment or control of seizure. Other conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's Disease). Treated with Botulinum Toxin Type A or B within the previous 4 months, or with phenol or therapeutic alcohol nerve block within 12 months or planned use of these drugs during this study. Has clinically significant limitation of passive range of motion of lower extremities. Has had major surgery within 6 months prior to Screening Visit that may affect spasticity assessments such as abdominal surgery, back surgery, lower leg and knee surgeries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Impax Study Director
Organizational Affiliation
Impax Laboratories, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
QUEST Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Great Falls Cllinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis

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