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Oral and IV Baclofen in Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749319
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : August 5, 2014
Paralyzed Veterans of America Research Foundation
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Baclofen Withdrawal Syndrome Drug: Oral baclofen Drug: Intervenous baclofen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
Active Comparator: Oral Baclofen Drug: Oral baclofen
Each subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days.

Experimental: Intervenous baclofen
Crossover study that eacg subject is given both oral and intervenous baclofen
Drug: Intervenous baclofen

Primary Outcome Measures :
  1. 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

  2. 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 - ∞).

  3. 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.

  4. 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

  5. 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

Secondary Outcome Measures :
  1. assessment of sedation [ Time Frame: up to 12 hours ]
    Sedation will be measured using the Stanford Sleepiness Scale.

  2. Ataxia [ Time Frame: up to 12 hours after infusion ]

    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.

  3. Nystagmus [ Time Frame: up to 12 hours following drug administration ]
    Nystagmus will be measured using the following scale. 0=none, 1=mild, 2=severe mild-present on extreme gaze; severe-present on midline gaze

  4. 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. ]
    diastolic and systolic blood pressure will be measured

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects will be eligible to participate in the study if all of the following conditions exist:

  1. Males and females between the ages of 18-65.
  2. Subjects are capable of giving informed consent.
  3. 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.
  4. 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.


Exclusion Criteria:

Subjects will be excluded from participation in the study if any of the following conditions exist:

  1. Women who are pregnant.
  2. Women who are breast feeding.
  3. Subject has a history of intolerance to IV administration of medication.
  4. Subject has a known hypersensitivity to baclofen.
  5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
  6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.
  7. Subject has taken either prescribed or over the counter medication for 48 hours prior to baclofen administration on either of the study days.
  8. Subject reveals clinically significant abnormalities on screening laboratory tests.
  9. Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749319

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Paralyzed Veterans of America Research Foundation

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Responsible Party: University of Minnesota Identifier: NCT01749319    
Other Study ID Numbers: CTSI 20873
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Keywords provided by University of Minnesota:
baclofen, withdrawal, interuption, spasticity, pharmacokinetics, tolerability, intravenous, oral
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders