A Study With IPX056 in Subjects With Spasticity Associated With Multip
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- IPX056
- Baclofen IR
Placebo
- Placebo IPX056
- Placebo IR
What it measured
Main measures
Morning Stiffness Score
6 weeks
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
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No results found
History
Started
Apr 2009
Main results due
Jan 2010
Finished
Feb 2010