Multiple SclerosisPhase 3NCT00488839
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
A Phase 3 study testing IPX056 20 mg, IPX056 40 mg and Encapsulated Baclofen 20 mg in people with Multiple Sclerosis, run by Impax Laboratories, LLC at 31 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- IPX056 20 mg, IPX056 40 mg and Encapsulated Baclofen 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Jun 2007to May 2008
- Phase
- Phase 3
- 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. If female and of childbearing potential, continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as oral, injected, or implanted contraceptives, or barrier contraception). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study. Female subjects of childbearing potential must have a negative urine pregnancy test immediately prior to study entry.
- Able to understand and willing to voluntarily sign an informed consent form (ICF) and an Authorization to Use and Disclose Protected Health Information form (as required by the Health Insurance Portability and Accountability Act {HIPAA} legislation, if appropriate for the region) prior to the performance of any study-specific procedures.
- Has a negative urine drug screen at screening visit.
- Has Definite multiple sclerosis by Poser or McDonald Criteria.
- Expanded Disability Status Scale (EDSS) rating between 3.0-8.0
- Has a normal ECG and a blood pressure <160/95 mmHg (systolic)/diastolic) at screening, measured in the sitting position after approximately 5 minutes of quiet rest.
Show all 10Show fewer
- If the subject has a history of or presence of clinically significant peptic ulcers, liver disease, diabetes mellitus, hypertension or heart disease, the subject must be on a stable treatment regimen for a minimum of 3 months prior to Screening Visit
- Wiling to wash out current medication with anti-spasticity activities, including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and tizanidine.
- Ashworth score of 2 or more for at least one of the three lower extremity muscle groups (hip adductor, knee flexor, knee extensor) in the most affected limb and a total minimum score of 6 for four muscle groups (the above three plus plantar flexor) on both limbs (maximum total score is 32) during screening visit and at pre-dose during PK/PD Visit 1.
- Able and willing to comply with the protocol, including availability for all scheduled clinic visits
Who cannot join
- If female, the subject is:
- 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).
- History of allergic or severe intolerance to baclofen.
- Did not respond to previous baclofen treatment in any formulation.
Show all 23Show fewer
- Treated with intrathecal baclofen within the previous 6 months prior to the Screening Visit.
- Has experienced an exacerbation of MS within 6 months prior to the Screening Visit.
- Symptomatic urinary tract infection (UTI) within 4 weeks prior to the Screening Visit and more than two (2) UTI incidents within the last 6 months.
- Serum creatinine level ≥ 2 x ULN (upper limit of normal reference range) at the Screening Visit or requires dialysis.
- Liver enzyme values ≥ 2 x ULN (upper limit of normal reference range) at the Screening Visit.
- Uncontrolled peptic ulcers, liver disease, diabetes mellitus, bladder sphincter hypertonia, hypertension or heart disease.
- History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment or control of seizure.
- Concomitant neurologic conditions causing spasticity (e.g. stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g. Parkinson's disease).
- Any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results, the conduct of the study, or the safety of the subject.
- Currently taking antipsychotics, CNS depressants or CNS depression producing medications (including alcohol, sedating antihistamines, barbiturates, narcotics, and phenothiazines), monoamine oxidase inhibitors (MAOI, including furazolidone, procarbazine, selegiline, and tranylcypromine), and tricyclics.
- Unable or unwilling to wash out current anti-spasticity medications, including but not limited to baclofen, benzodiazepines, clonazepam, clonidine, dantrolene, diazepam, gabapentin, and/or tizanidine for Day 1, Visit 1, procedures. However, these medications will be allowed during open label study.
- Unable or unwilling to participate 12-hour PK/PD procedures during Visit 1.
- Treated with Botulinum Toxin Type A or B within the previous 6 months, or Phenol or therapeutic alcohol nerve block within 12 months prior to the Screening Visit.
- History of alcohol abuse or use of recreational drugs within 12 months prior to the Screening Visit.
- Has received an investigational drug or device within 30 days prior to the Screening Visit.
- Has clinically significant limitation of passive range of motion around any of the joints being assessed in this study.
- Has had major surgery within 3 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
31 sites in 5 countries.
31 sites in 5 countries
United States20 sites
General Clinical Research Center 7A
Ann Arbor, Michigan, 48109
MS Center of Atlanta
Atlanta, Georgia, 30327
Neurological Research Center
Bennington, Vermont, 05201
Patricia Fodor
Colorado Springs, Colorado, 80919
Elkhardt Clinic
Elkhart, Indiana, 46514
Sunrise Clinical Research
Hollywood, Florida, 33021
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214
OrthoArkansas, P. A.
Little Rock, Arkansas, 72201
OrthoArkansas, P.A.
Little Rock, Arkansas, 72201
Bhupesh Dihenia
Lubbock, Texas, 79410
Winthrop University Hospital
Mineola, New York, 11501
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Medex Healthcare Research, Inc.
Saint Louis, Michigan, 63117
Integra Clinical Research
San Antonio, Texas, 78229
Springfield Neurology
Springfield, Massachusetts, 01104
Meridien Research
Tampa, Florida, 33606
Northern Michigan Neurology
Traverse City, Michigan, 49684
Northwest NeuroSpecialists
Tucson, Arizona, 85741
Crozer Chester Medical Center
Upland, Pennsylvania, 19013
Ukraine7 sites
Chernihiv Regional Hospital Department of Neurology
Chernihiv, 14029
Neurology and Neurosurgery Dpt., Postgraduation training faculty, Dnipropetrovsk State medical Academy
Dnipropetrovsk, 49027
Institue of Neruology, Psychiatry and Narcology of AMS of Ukraine
Kharkiv, 61068
Department of nervous system demyelization diseases of City Clinical Hospital
Kyiv, 03110
Odessa Regional Clinical Hospital
Odesa, 65025
Neurology department of Ukraine medical stomatological akademy
Poltava, 36024
Vinnytsya Regional Psychoneurological Hospital
Vinnytsia, 21005
Canada2 sites
Foothills Medical Centre, MS Clinic, SSB
Calgary, t2n 2t9
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
About this study
Official title: A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
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.
Read the detailed description
The primary objective of this study is to demonstrate that IPX056 reduces spasticity, measured by Ashworth score, in subjects with multiple sclerosis (MS). This study will also (1) assess the correlation between pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Ashworth score), and (2) quantify the duration of pharmacodynamic effects for IPX056 as well as marketed baclofen tablet in subjects with Multiple Sclerosis (MS) after a single dose. Additionally, the efficacy parameters, including Multiple Sclerosis Impact Scale (MSIS)-29, spasm frequency and nighttime awakening score, spasticity control, morning stiffness, and Global Assessment of Efficacy and Tolerability, will be assessed during open-label extension period. The safety of IPX056 will be monitored throughout the study.
This study consists of 2 parts: Part I (Screening Visit \& Visit 1) of the study is a single-dose, double-blind, randomized, placebo- and active comparator-controlled, parallel group design containing a single 12 hour PK/PD evaluation period. Part II is an optional, approximately 9-week open-label extension study and will start during Visit 1, immediately after Visit 1 PK/PD procedures are completed.
- Conditions
- Multiple Sclerosis
- Being tested
- IPX056 20 mg, IPX056 40 mg, Encapsulated Baclofen 20 mg, Placebo Baclofen Tablet, IPX056 10 mg
- Keywords
- Spasticity, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPX056 20 mgDrug
Also called Baclofen ER 20 mg
IPX056 Extended Release capsule containing 20 mg baclofen
IPX056 40 mgDrug
Also called Baclofen ER 40 mg
IPX056 Extended Release capsule containing 40 mg baclofen
Encapsulated Baclofen 20 mgDrug
Also called Active comparator
Baclofen 20mg tablet was encapsulated for blinding.
Placebo Baclofen TabletDrug
Placebo capsule encapsulated placebo Baclofen tablet
IPX056 10 mgDrug
Also called Baclofen ER 10 mg
IPX056 Extended Release capsule containing 10 mg baclofen
IPX056 30 mgDrug
Also called Baclofen ER 30 mg
IPX056 Extended Release capsule containing 30 mg baclofen
IPX056 35 mgDrug
Also called Baclofen ER 35 mg
IPX056 Extended Release capsule containing 35 mg baclofen
Placebo IPX056 20 mgDrug
Placebo capsule for IPX056 20 mg
Placebo IPX056 40 mgDrug
Placebo capsule for IPX056 40 mg
| Study group | Role | What they receive |
|---|---|---|
| IPX056 20 mg - OLE | Other | A single dose of IPX056 20 mg, Placebo IPX056 40 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) Receives: Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 40 mg |
| IPX056 40 mg - OLE | Other | A single dose of IPX056 40 mg, Placebo IPX056 20 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) Receives: Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg |
| Baclofen 20 mg - OLE | Other | A single dose of Encapsulated Baclofen 20 mg, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) Receives: Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg; Drug: Placebo IPX056 40 mg |
| Placebo - OLE | Other | A single dose of Placebo Baclofen Tablet, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design,IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) Receives: Drug: IPX056 20 mg; Drug: IPX056 40 mg; Drug: Encapsulated Baclofen 20 mg; Drug: Placebo Baclofen Tablet; Drug: IPX056 10 mg; Drug: IPX056 30 mg; Drug: IPX056 35 mg; Drug: Placebo IPX056 20 mg; Drug: Placebo IPX056 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours
Secondary outcomes (2)
Duration of effect (improvement in Ashworth Scale) for IPX056
Measured: 12 hours
Establishment of relationships between baclofen plasma concentration with improvement in Ashworth Scale
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 173 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
- NCT00488839
- Sponsor's protocol ID
- IPX056-B06-03
- Other IDs
- 2007-000236-16
- Status last verified
- Feb 2017
- First submitted
- 18 Jun 2007
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00488839
- Acronym / sponsor ID
- IPX056-B06-03
- Conditions
- Multiple Sclerosis
- Keywords
- Spasticity, Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Jun 2007 (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.
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.
Detailed description
The primary objective of this study is to demonstrate that IPX056 reduces spasticity, measured by Ashworth score, in subjects with multiple sclerosis (MS). This study will also (1) assess the correlation between pharmacokinetic (PK) and pharmacodynamic (PD) endpoints (Ashworth score), and (2) quantify the duration of pharmacodynamic effects for IPX056 as well as marketed baclofen tablet in subjects with Multiple Sclerosis (MS) after a single dose. Additionally, the efficacy parameters, including Multiple Sclerosis Impact Scale (MSIS)-29, spasm frequency and nighttime awakening score, spasticity control, morning stiffness, and Global Assessment of Efficacy and Tolerability, will be assessed during open-label extension period. The safety of IPX056 will be monitored throughout the study.
This study consists of 2 parts: Part I (Screening Visit \& Visit 1) of the study is a single-dose, double-blind, randomized, placebo- and active comparator-controlled, parallel group design containing a single 12 hour PK/PD evaluation period. Part II is an optional, approximately 9-week open-label extension study and will start during Visit 1, immediately after Visit 1 PK/PD procedures are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPX056 20 mg - OLE | Other | Drug: IPX056 20 mg, Drug: IPX056 40 mg, Drug: Encapsulated Baclofen 20 mg, Drug: Placebo Baclofen Tablet, Drug: IPX056 10 mg, Drug: IPX056 30 mg, Drug: IPX056 35 mg, Drug: Placebo IPX056 40 mgA single dose of IPX056 20 mg, Placebo IPX056 40 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) |
| IPX056 40 mg - OLE | Other | Drug: IPX056 20 mg, Drug: IPX056 40 mg, Drug: Encapsulated Baclofen 20 mg, Drug: Placebo Baclofen Tablet, Drug: IPX056 10 mg, Drug: IPX056 30 mg, Drug: IPX056 35 mg, Drug: Placebo IPX056 20 mgA single dose of IPX056 40 mg, Placebo IPX056 20 mg and Placebo Baclofen Tablet (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) |
| Baclofen 20 mg - OLE | Other | Drug: IPX056 20 mg, Drug: IPX056 40 mg, Drug: Encapsulated Baclofen 20 mg, Drug: IPX056 10 mg, Drug: IPX056 30 mg, Drug: IPX056 35 mg, Drug: Placebo IPX056 20 mg, Drug: Placebo IPX056 40 mgA single dose of Encapsulated Baclofen 20 mg, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design, IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) |
| Placebo - OLE | Other | Drug: IPX056 20 mg, Drug: IPX056 40 mg, Drug: Encapsulated Baclofen 20 mg, Drug: Placebo Baclofen Tablet, Drug: IPX056 10 mg, Drug: IPX056 30 mg, Drug: IPX056 35 mg, Drug: Placebo IPX056 20 mg, Drug: Placebo IPX056 40 mgA single dose of Placebo Baclofen Tablet, Placebo IPX056 20 mg and Placebo IPX056 40 mg (Part 1), 9 week Open label extension of IPX056 (flexible dose design,IPX056 10 mg, IPX056 20 mg, IPX056 30 mg, IPX056 35 mg, or IPX056 40 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female at least 18 years old. If female and of childbearing potential, continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as oral, injected, or implanted contraceptives, or barrier contraception). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study. Female subjects of childbearing potential must have a negative urine pregnancy test immediately prior to study entry.
- Able to understand and willing to voluntarily sign an informed consent form (ICF) and an Authorization to Use and Disclose Protected Health Information form (as required by the Health Insurance Portability and Accountability Act {HIPAA} legislation, if appropriate for the region) prior to the performance of any study-specific procedures.
- Has a negative urine drug screen at screening visit.
- Has Definite multiple sclerosis by Poser or McDonald Criteria.
- Expanded Disability Status Scale (EDSS) rating between 3.0-8.0
Key exclusion criteria (23 listed)
- If female, the subject is:
- History of allergic or severe intolerance to baclofen.
- Did not respond to previous baclofen treatment in any formulation.
- Treated with intrathecal baclofen within the previous 6 months prior to the Screening Visit.
- Has experienced an exacerbation of MS within 6 months prior to the Screening Visit.
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 |
|---|---|---|
| IPX056 20 mgAlso: Baclofen ER 20 mgIPX056 Extended Release capsule containing 20 mg baclofen | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| IPX056 40 mgAlso: Baclofen ER 40 mgIPX056 Extended Release capsule containing 40 mg baclofen | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| Encapsulated Baclofen 20 mgAlso: Active comparatorBaclofen 20mg tablet was encapsulated for blinding. | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| Placebo Baclofen TabletPlacebo capsule encapsulated placebo Baclofen tablet | Drug | IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| IPX056 10 mgAlso: Baclofen ER 10 mgIPX056 Extended Release capsule containing 10 mg baclofen | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| IPX056 30 mgAlso: Baclofen ER 30 mgIPX056 Extended Release capsule containing 30 mg baclofen | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| IPX056 35 mgAlso: Baclofen ER 35 mgIPX056 Extended Release capsule containing 35 mg baclofen | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| Placebo IPX056 20 mgPlacebo capsule for IPX056 20 mg | Drug | Baclofen 20 mg - OLE, IPX056 40 mg - OLE, Placebo - OLE |
| Placebo IPX056 40 mgPlacebo capsule for IPX056 40 mg | Drug | Baclofen 20 mg - OLE, IPX056 20 mg - OLE, Placebo - OLE |
Primary outcome
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
Time frame: 12 hours
2 secondary outcomes
Duration of effect (improvement in Ashworth Scale) for IPX056
Time frame: 12 hours
Establishment of relationships between baclofen plasma concentration with improvement in Ashworth Scale
Time frame: 12 hours
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
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IPX056 20 mg, IPX056 40 mg and Encapsulated Baclofen 20 mg in people with Multiple Sclerosis, run by Impax Laboratories, LLC at 31 sites in 5 countries.
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 10 inclusion and 23 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 31 sites in United States, Ukraine, Canada, Estonia, Latvia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 (time frame: 12 hours). 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.