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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00431171 |
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Date of registration:
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01/02/2007 |
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Primary sponsor: |
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Public title:
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Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury
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Scientific title:
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A Three Month, Open-label, Single-arm Trial Evaluating the Safety and Pharmacokinetics of Oral Lithium in Patients Diagnosed With Chronic Spinal Cord Injury |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00431171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Yat-wa Wong, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects of either gender and 18 - 60 years of age (preferably 10 males and females
each)
- Subjects with chronic spinal cord injury (defined as 12 months or more post spinal
cord injury), as confirmed by a MRI
- Subjects with neurological status: ASIA A, B or C
- Subjects must be able to read, understand, and complete the VAS
- Subjects who have voluntarily signed* and dated* an informed consent form, approved
by an IEC/IRB, prior to any study-specific procedures *If a subject consents to
participation but is not in a position to personally sign and date the informed
consent form because of his or her physical condition, the consent must be confirmed
at the time of consent orally, signed on behalf by the subject's relative, and by an
impartial witness who is present throughout the whole informed consent process.
Exclusion Criteria: Subjects are excluded if they have
- a history of hypersensitivity to lithium
- significant renal, cardiovascular, hepatic and psychiatric diseases
- significant medical diseases or infection
- brain injury
- Addison's disease
- debilitation or dehydration
- recently taken or are taking diuretics or other drugs with known interaction with
lithium, such as tricyclic antidepressants, NSAIDs and tetracycline
- a history of alcohol abuse or drug abuse, or if they are
- pregnant or lactating women;
- female of childbearing potential and are unwilling to use an effective contraceptive
method while enrolled in the study;
- subjects who are currently participating in another investigational study or have
been taking any investigational drug within the last 4 weeks prior to screening of
this study (Visit 1); and finally,
- any criteria, which, in the opinion of the investigator, suggest that the subject
would not be compliant with the study protocol.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injuries
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Intervention(s)
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Drug: Lithium carbonate
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Primary Outcome(s)
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Incidence of clinical adverse events including known and unknown adverse events, and changes from baseline in vital signs, ECGs and laboratory parameters
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Secondary Outcome(s)
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Plasma lithium level
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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