CompletedPhase 3

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

United States173 participantsStarted 2007-06

Plain-language summary

The purpose of this study is to determine the effects, both good and bad, of IPX056 on subjects and their spasticity. This study will also determine the relationship between the amount of IPX056 in blood and the effects on spasticity. Lastly, this study will determine how long IPX056 affects spasticity.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. pregnant; or planning to become pregnant; or
✕. breastfeeding; or
✕. a woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant \[i.e., not surgically sterile\]) who is engaged in active heterosexual relations and is not using a barrier or hormonal form of birth control (i.e. oral, injected, or implanted contraceptives).

What they're measuring

Overall mean changes from predose (baseline) in total Ashworth scores of the four lower extremity muscle groups (hip adductors, knee flexors, knee extensors, and plantar flexors) of both lower limbs over 12 hours assessed hourly after dosing

Timeframe: 12 hours

Trial details

NCT IDNCT00488839

SponsorImpax Laboratories, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

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