Oral and IV Baclofen in Adult Volunteers

NCT ID: NCT01749319

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Baclofen Withdrawal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Baclofen

Group Type: ACTIVE_COMPARATOR

Oral baclofen

Intervention Type: DRUG

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

Intervenous baclofen

Crossover study that eacg subject is given both oral and intervenous baclofen

Group Type: EXPERIMENTAL

Intervenous baclofen

Intervention Type: DRUG

Interventions

Oral baclofen

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

Intervention Type: DRUG

Intervenous baclofen

Intervention Type: DRUG

Eligibility Criteria

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.

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paralyzed Veterans of America Research Foundation

UNKNOWN

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CTSI 20873

Identifier Type: -

Identifier Source: org_study_id