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

• Sponsor: Impax Laboratories, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00914290
• Collaborator: (none)
• Enrollment: 23
• Locations: 11
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Spasticity; Multiple Sclerosis	Drug: IPX056; Drug: Baclofen IR; Drug: Placebo IPX056; Drug: Placebo IR	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: IPX056-Baclofen IR-IPX056 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.	Drug: IPX056; IPX056 ER capsule containing 10 mg baclofen; Other Names: IPX056 ER Capsule IPX056 ER ; Drug: Baclofen IR; Encapsulated baclofen tablet 5 mg per capsule; Other Names: CAS Registry Number [11134-47-0] ; Drug: Placebo IPX056; Placebo capsule for IPX056; Drug: Placebo IR; Placebo encapsulated baclofen placebo tablet
Active Comparator: IPX056-IPX056-Baclofen IR 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.	Drug: IPX056; IPX056 ER capsule containing 10 mg baclofen; Other Names: IPX056 ER Capsule IPX056 ER ; Drug: Baclofen IR; Encapsulated baclofen tablet 5 mg per capsule; Other Names: CAS Registry Number [11134-47-0] ; Drug: Placebo IPX056; Placebo capsule for IPX056; Drug: Placebo IR; Placebo encapsulated baclofen placebo tablet

Outcome Measures

Primary Outcome Measures

1. Morning Stiffness Score [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest NeuroSpecialists, PLLC	Tucson	Arizona	United States	85741
2	University of Colorado	Aurora	Colorado	United States	80045
3	Meridien Research	Tampa	Florida	United States	33606
4	Fort Wayne Neurological Center	Fort Wayne	Indiana	United States	46805
5	MidAmerica Neuroscience Institute	Lenexa	Kansas	United States	66214
6	QUEST Research Institute	Bingham Farms	Michigan	United States	48025
7	Great Falls Cllinic	Great Falls	Montana	United States	59405
8	Empire Neurology, PC	Latham	New York	United States	12110
9	Winthrop University Hospital	Mineola	New York	United States	11501
10	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
11	Central Texas Neurology Consultants	Round Rock	Texas	United States	78681

Sponsors and Collaborators

• Impax Laboratories, LLC

Investigators

• Study Director: Impax Study Director, Impax Laboratories, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Impax Laboratories, LLC
• ClinicalTrials.gov Identifier: NCT00914290
• Other Study ID Numbers: IPX056-B09-01
• First Posted: Jun 4, 2009
• Last Update Posted: Nov 6, 2019
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis; Baclofen

Study Results

No Results Posted as of Nov 6, 2019