SpasticityPhase 2NCT00914290
A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
A Phase 2 study testing IPX056 and Baclofen IR in people with Spasticity and Multiple Sclerosis, run by Impax Laboratories, LLC at 11 sites in United States.
Trial summary
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Multiple Sclerosis
- What is being tested?
- IPX056 and Baclofen IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Colorado
Aurora, Colorado, 80045
QUEST Research Institute
Bingham Farms, Michigan, 48025
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805
Great Falls Cllinic
Great Falls, Montana, 59405
Empire Neurology, PC
Latham, New York, 12110
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214
Winthrop University Hospital
Mineola, New York, 11501
Central Texas Neurology Consultants
Round Rock, Texas, 78681
Meridien Research
Tampa, Florida, 33606
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
To explore the safety and efficacy of IPX056 compared with baclofen tablets for alleviation of symptoms of spasticity associated with multiple sclerosis (MS).
Read the 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.
- Conditions
- Spasticity, Multiple Sclerosis
- Being tested
- IPX056, Baclofen IR, Placebo IPX056, Placebo IR
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPX056Drug
Also called IPX056 ER Capsule, IPX056 ER
IPX056 ER capsule containing 10 mg baclofen
Baclofen IRDrug
Also called CAS Registry Number [11134-47-0]
Encapsulated baclofen tablet 5 mg per capsule
Placebo IPX056Drug
Placebo capsule for IPX056
Placebo IRDrug
Placebo encapsulated baclofen placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| IPX056-Baclofen IR-IPX056 | Other | 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. Receives: Drug: IPX056; Drug: Baclofen IR; Drug: Placebo IPX056; Drug: Placebo IR |
| IPX056-IPX056-Baclofen IR | Active comparator | 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. Receives: Drug: IPX056; Drug: Baclofen IR; Drug: Placebo IPX056; Drug: Placebo IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning Stiffness Score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impax Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Impax Study Director, Study director, Impax Laboratories, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914290
- Sponsor's protocol ID
- IPX056-B09-01
- Status last verified
- May 2017
- First submitted
- 2 Jun 2009
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00914290
- Acronym / sponsor ID
- IPX056-B09-01
- Conditions
- Spasticity, Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPX056-Baclofen IR-IPX056 | Other | Drug: IPX056, Drug: Baclofen IR, Drug: Placebo IPX056, Drug: Placebo IRFollowing 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. |
| IPX056-IPX056-Baclofen IR | Active comparator | Drug: IPX056, Drug: Baclofen IR, Drug: Placebo IPX056, Drug: Placebo IRFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPX056Also: IPX056 ER Capsule, IPX056 ERIPX056 ER capsule containing 10 mg baclofen | Drug | IPX056-Baclofen IR-IPX056, IPX056-IPX056-Baclofen IR |
| Baclofen IRAlso: CAS Registry Number [11134-47-0]Encapsulated baclofen tablet 5 mg per capsule | Drug | IPX056-Baclofen IR-IPX056, IPX056-IPX056-Baclofen IR |
| Placebo IPX056Placebo capsule for IPX056 | Drug | IPX056-Baclofen IR-IPX056, IPX056-IPX056-Baclofen IR |
| Placebo IRPlacebo encapsulated baclofen placebo tablet | Drug | IPX056-Baclofen IR-IPX056, IPX056-IPX056-Baclofen IR |
Primary outcome
Morning Stiffness Score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Impax Study Director study director
Impax Laboratories, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPX056 and Baclofen IR in people with Spasticity and Multiple Sclerosis, run by Impax Laboratories, LLC at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning Stiffness Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.