Intravenous BaclofenPhase 1/2NCT02760992
Repeated Dose IV Baclofen Safety/Bioequivalence Study
A Phase 1/2 study testing IV Baclofen and Oral Baclofen in people with Intravenous Baclofen, run by Allaysis, LLC.
Trial summary
The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as a temporary substitute for an oral regimen. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Baclofen
- What is being tested?
- IV Baclofen and Oral Baclofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Dec 2017
- Phase
- Phase 1/2
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between the ages of 18-45. An attempt will be made to recruit an equal number of men and women into each dosing group; however a ratio of 2:4 in the initial run-in phase and 12:18, with either women or men in the majority is acceptable.
- Subjects are capable of giving informed consent.
- Females capable of bearing children should practice at least one or more of the following methods of contraception for at least one month prior to the and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide. Female subjects who are postmenopausal (no menses for greater than one year) or surgically incapable of bearing children may participate.
- Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after completion of study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.
Who cannot join
- Women who are pregnant.
- Women who are breastfeeding.
- Subject has a history of intolerance to IV administration of medication.
- Subject has a known hypersensitivity to baclofen.
- Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
- Subject has taken or used any investigational drug or device in the 30 days prior to screening.
Show all 9Show fewer
- Subject has taken either prescribed or over the counter medication, other than hormonal birth control within 48 hours prior to baclofen administration, unless approved by the Principal Investigator.
- Subject reveals clinically significant abnormalities on screening laboratory tests.
- Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.
About this study
Official title: Steady-State Bioequivalence Study of Multiple Doses of Oral Versus Intravenous Baclofen in Healthy Adult Volunteers
The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as a temporary substitute for an oral regimen.
Read the detailed description
Baclofen intravenous solution 2 mg/mL will be manufactured and provided by Allaysis, LLC. Prism Clinical Research will purchase oral baclofen tablets (10 mg) from a commercial supplier. Subject will start baclofen at a 5 mg oral dose every 8 hours. Oral baclofen will be increased incrementally and self-administered over 13 days to a maximum dose of 20 mg every 8 hours. Subjects will be crossed over to 16 mg intravenous baclofen infused over 120 (n=6) or 150 (n=6) minutes every 8 hours for 11 doses. Subjects will be changed back to oral baclofen at a 15 mg dose self-administered every 8 hours and tapered off of baclofen over 15 days. Following the completion of this group of 12 subjects, the remaining 30 subjects will receive IV baclofen at the infusion duration that best meets the criteria for bioequivalence.
- Conditions
- Intravenous Baclofen
- Being tested
- IV Baclofen, Oral Baclofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV BaclofenDrug
Baclofen intravenous solution 2 mg/mL manufactured and provided by Allaysis, LLC
Oral BaclofenDrug
10 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Oral Baclofen | Active comparator | Subject will start baclofen at a 5 mg oral dose every 8 hours. Oral baclofen will be increased incrementally and self-administered over 13 days to a maximum dose of 20 mg every 8 hours. Following IV administration, subjects will be changed back to oral baclofen at a 15 mg dose self-administered every 8 hours and tapered off of baclofen over 15 days. Receives: Drug: Oral Baclofen |
| IV Baclofen | Experimental | Subjects will be crossed over to 16 mg intravenous baclofen infused over 120 or 150 minutes every 8 hours for 11 doses. Receives: Drug: IV Baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of IV Baclofen Relative to Oral at Steady State
Evaluate and confirm selected infusion rates of IV baclofen which best achieve bioequivalence to oral baclofen at steady state in healthy adults.
Measured: 2 dosing intervals (total of 16 hours)
Secondary outcomes (5)
Number of participants experiencing sedation due to the treatment measured by the sanford sleepiness scale
Over the course of the intervention (~3 months) subjects will be assessed using the Modified Sanford sleepiness scale prior to the first and second intravenous drug administration then every 30 minutes for four hours after drug administration. If this assessment shows that the subject is not at their baseline, assessments will continue every 30 minutes until the subject has returned to the baseline function.
Measured: 3 months
Number of participants experiencing nystagmus due to the treatment.
Over the course of the intervention (~3 months) subjects will be assessed using the following rating scale and definitions of ataxia and nystagmus prior to the first and second intravenous drug administrations then every 30 minutes for four hours after drug administration. If this assessment shows that the subject is not at their baseline, assessments will continue every 30 minutes until the subject has returned to the baseline function.
Nystagmus:
0 = None
- mild - present only on extreme gaze (beyond 45 degrees lateral gaze)
- severe - present on neutral to 45 degrees lateral gaze
Measured: 3 months
Number of participants experiencing ataxia due to the treatment measured by tandem gait
Over the course of the intervention (~3 months) subjects will be assessed using the following rating scale and definitions of ataxia and nystagmus prior to the first and second intravenous drug administrations then every 30 minutes for four hours after drug administration. If this assessment shows that the subject is not at their baseline, assessments will continue every 30 minutes until the subject has returned to the baseline function.
Ataxia: For those who are ambulatory, this will be assessed by gait. Ratings will be: 0=none
- Mild - unsteady with tandem gait testing, but able to perform without assistance
- Severe - unable to perform gait testing without assistance. For non-ambulatory subjects, ataxia will be assessed by finger to nose and finger pursuit maneuvers.
Measured: 3 months
Peak Plasma Concentration (Cmax)
Cmax will be determined on visual observation.
Measured: 3 months
Area Under the Curve (AUC)
Pharmacokinetic analysis will be performed with WinNonLin (Pharsight), a pharmacokinetic data analysis package, and will include calculation of the area under the concentration-time curve (AUC).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2017
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous BaclofenStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allaysis, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760992
- Sponsor's protocol ID
- CTSI - 24347
- Status last verified
- Nov 2016
- First submitted
- 26 Feb 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steady-State Bioequivalence Study of Multiple Doses of Oral Versus Intravenous Baclofen in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02760992
- Acronym / sponsor ID
- CTSI - 24347
- Conditions
- Intravenous Baclofen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Allaysis, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- May 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 May 2016 (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 identify a suitable dosing regimen of IV baclofen to serve as a temporary substitute for an oral regimen.
Detailed description
Baclofen intravenous solution 2 mg/mL will be manufactured and provided by Allaysis, LLC. Prism Clinical Research will purchase oral baclofen tablets (10 mg) from a commercial supplier. Subject will start baclofen at a 5 mg oral dose every 8 hours. Oral baclofen will be increased incrementally and self-administered over 13 days to a maximum dose of 20 mg every 8 hours. Subjects will be crossed over to 16 mg intravenous baclofen infused over 120 (n=6) or 150 (n=6) minutes every 8 hours for 11 doses. Subjects will be changed back to oral baclofen at a 15 mg dose self-administered every 8 hours and tapered off of baclofen over 15 days. Following the completion of this group of 12 subjects, the remaining 30 subjects will receive IV baclofen at the infusion duration that best meets the criteria for bioequivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Baclofen | Active comparator | Drug: Oral BaclofenSubject will start baclofen at a 5 mg oral dose every 8 hours. Oral baclofen will be increased incrementally and self-administered over 13 days to a maximum dose of 20 mg every 8 hours. Following IV administration, subjects will be changed back to oral baclofen at a 15 mg dose self-administered every 8 hours and tapered off of baclofen over 15 days. |
| IV Baclofen | Experimental | Drug: IV BaclofenSubjects will be crossed over to 16 mg intravenous baclofen infused over 120 or 150 minutes every 8 hours for 11 doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between the ages of 18-45. An attempt will be made to recruit an equal number of men and women into each dosing group; however a ratio of 2:4 in the initial run-in phase and 12:18, with either women or men in the majority is acceptable.
- Subjects are capable of giving informed consent.
- Females capable of bearing children should practice at least one or more of the following methods of contraception for at least one month prior to the and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide. Female subjects who are postmenopausal (no menses for greater than one year) or surgically incapable of bearing children may participate.
- Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after completion of study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.
Key exclusion criteria (9 listed)
- Women who are pregnant.
- Women who are breastfeeding.
- Subject has a history of intolerance to IV administration of medication.
- Subject has a known hypersensitivity to baclofen.
- Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
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 |
|---|---|---|
| IV BaclofenBaclofen intravenous solution 2 mg/mL manufactured and provided by Allaysis, LLC | Drug | IV Baclofen |
| Oral Baclofen10 mg tablet | Drug | Oral Baclofen |
Primary outcome
Bioequivalence of IV Baclofen Relative to Oral at Steady State
Time frame: 2 dosing intervals (total of 16 hours)
Evaluate and confirm selected infusion rates of IV baclofen which best achieve bioequivalence to oral baclofen at steady state in healthy adults.
5 secondary outcomes
Number of participants experiencing sedation due to the treatment measured by the sanford sleepiness scale
Time frame: 3 months
Number of participants experiencing nystagmus due to the treatment.
Time frame: 3 months
Number of participants experiencing ataxia due to the treatment measured by tandem gait
Time frame: 3 months
Peak Plasma Concentration (Cmax)
Time frame: 3 months
Area Under the Curve (AUC)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: Undecided. Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IV Baclofen and Oral Baclofen in people with Intravenous Baclofen, run by Allaysis, LLC.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Bioequivalence of IV Baclofen Relative to Oral at Steady State (time frame: 2 dosing intervals (total of 16 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 29 Nov 2016.