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NCT Number: NCT01749319

Oral and IV Baclofen in 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.

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Key information

Conditions

Baclofen Withdrawal Syndrome Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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Exclusion criteria

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
  • 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.

Treatment and study plan

Oral baclofen

Drug

Each subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days.

Intervenous baclofen

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Paralyzed Veterans of America Research Foundation

Registry information

Official study title

Prevention of Baclofen Withdrawal Syndrome: Two-Way Crossover Study of Oral and Intravenous Baclofen in Healthy Adult Volunteers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2012
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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