Baclofen Withdrawal SyndromePhase 1NCT01749319
Oral and IV Baclofen in Adult Volunteers
A Phase 1 study testing Oral baclofen and Intervenous baclofen in people with Baclofen Withdrawal Syndrome, run by University of Minnesota at 1 site in United States.
Trial summary
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Baclofen Withdrawal Syndrome
- What is being tested?
- Oral baclofen and Intervenous 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- Males and females between the ages of 18-65.
- Subjects are capable of giving informed consent.
- Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
- Subject should be medication free, other than study drug, for 48 hours before through 24 hours after 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
- Subjects will be excluded from participation in the study if any of the following conditions exist:
- Women who are pregnant.
- Women who are breast feeding.
- 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
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- Subject has taken or used any investigational drug or device in the 30 days prior to screening.
- Subject has taken either prescribed or over the counter medication for 48 hours prior to baclofen administration on either of the study days.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation.
This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner.
The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.
- Conditions
- Baclofen Withdrawal Syndrome
- Being tested
- Oral baclofen, Intervenous baclofen
- Keywords
- baclofen, withdrawal, interuption, spasticity, pharmacokinetics, tolerability, intravenous, oral
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral baclofenDrug
Each subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days.
Intervenous baclofenDrug
| Study group | Role | What they receive |
|---|---|---|
| Oral Baclofen | Active comparator | Not described Receives: Drug: Oral baclofen |
| Intervenous baclofen | Experimental | Crossover study that eacg subject is given both oral and intervenous baclofen Receives: Drug: Intervenous baclofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral bioavailability
oral bioavailability is the fraction of an administered dose of unchanged drug that reaches the systemic circulation
Measured: 5, 15, 30 minutes, and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Maximum concentration (Cmax)
The maximum concentration is the maximum baclofen concentration observed
Measured: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Tmax
Tmax is the time at which the maximum baclofen concentration was observed
Measured: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Secondary outcomes (4)
assessment of sedation
Sedation will be measured using the Stanford Sleepiness Scale.
Measured: up to 12 hours
Ataxia
A rating scale of ataxia will be used:
0=none, 1=mild, 2=severe
For those who are ambulatory, this will be assessed by gait. Ratings will be:
mild-unsteady with tandem gait testing, but able to perform without assistance severe-unable to perform tandem gait testing without assistance. For non-ambulatory subjects, ataxia will be assessed by finger to nose and finger pursuit maneuvers.
Measured: up to 12 hours after infusion
Nystagmus
Nystagmus will be measured using the following scale. 0=none, 1=mild, 2=severe mild-present on extreme gaze; severe-present on midline gaze
Measured: up to 12 hours following drug administration
blood pressure
diastolic and systolic blood pressure will be measured
Measured: 5 minutes immediately prior to, and during the IV infusion and oral administration, then every 15 minutes for 1 hour, then every hour for 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baclofen Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Paralyzed Veterans of America Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749319
- Sponsor's protocol ID
- CTSI 20873
- Status last verified
- Aug 2014
- First submitted
- 4 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01749319
- Acronym / sponsor ID
- CTSI 20873
- Conditions
- Baclofen Withdrawal Syndrome
- Keywords
- baclofen, withdrawal, interuption, spasticity, pharmacokinetics, tolerability, intravenous, oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Paralyzed Veterans of America Research Foundation
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Dec 2012 (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 primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation.
This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1:1 manner.
The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Baclofen | Active comparator | Drug: Oral baclofen |
| Intervenous baclofen | Experimental | Drug: Intervenous baclofenCrossover study that eacg subject is given both oral and intervenous baclofen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- Males and females between the ages of 18-65.
- Subjects are capable of giving informed consent.
- Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
- Subject should be medication free, other than study drug, for 48 hours before through 24 hours after 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 (10 listed)
- Subjects will be excluded from participation in the study if any of the following conditions exist:
- Women who are pregnant.
- Women who are breast feeding.
- Subject has a history of intolerance to IV administration of medication.
- Subject has a known hypersensitivity to baclofen.
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 |
|---|---|---|
| Oral baclofenEach subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days. | Drug | Oral Baclofen |
| Intervenous baclofen | Drug | Intervenous baclofen |
Primary outcome
oral bioavailability
Time frame: 5, 15, 30 minutes, and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
oral bioavailability is the fraction of an administered dose of unchanged drug that reaches the systemic circulation
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Plasma Decay Half-Life (t1/2)
Time frame: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Maximum concentration (Cmax)
Time frame: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
The maximum concentration is the maximum baclofen concentration observed
Tmax
Time frame: 5, 15, 30 min and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration
Tmax is the time at which the maximum baclofen concentration was observed
4 secondary outcomes
assessment of sedation
Time frame: up to 12 hours
Ataxia
Time frame: up to 12 hours after infusion
Nystagmus
Time frame: up to 12 hours following drug administration
blood pressure
Time frame: 5 minutes immediately prior to, and during the IV infusion and oral administration, then every 15 minutes for 1 hour, then every hour for 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 5 Aug 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral baclofen and Intervenous baclofen in people with Baclofen Withdrawal Syndrome, run by University of Minnesota at 1 site 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 6 inclusion and 10 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
oral bioavailability (time frame: 5, 15, 30 minutes, and 1, 2, 4, 6, 8, 10, 12, and 24 hours after administration). The study lists 5 primary outcomes in all. 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 5 Aug 2014.