Status:
COMPLETED
Pregabalin in the Treatment of Essential Tremor
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Pfizer
Conditions:
Essential Tremor
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for us...
Detailed Description
Overview We propose a single site, double-blind, placebo-controlled, cross-over design. Drug will be administered in 75mg capsules with a target dose of 300 mg/day. Pregabalin will be titrated upward ...
Eligibility Criteria
Inclusion
- Subjects must be between the ages of 18 and 80 inclusive.
- Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or severe tremor in head or arms for at least 3 years duration. - No present causes of enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug withdrawal states. - No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. - No historic or clinical evidence of psychogenic tremor origin.
- Subjects with a history of seizures are eligible.
- Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
- Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these criteria must be stopped for 5 half-lives prior to study initiation.
- Subjects must be accessible by telephone.
- If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry (or a negative urine pregnancy test within one week of study entry): - Hormonal contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility
- Prior to participation in this study, each subject must sign an informed consent.
Exclusion
- Patients do not meet TRIG criteria for probable ET.
- Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
- Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement.
- Subjects who have exhibited any psychotic symptomatology.
- Subjects who have known renal deficiencies.
- Subjects who have been intolerant of pregabalin in the past
- Prior surgical treatment for tremor.
- Patients currently taking more than a single drug for ET.
- Patients taking anti-seizure medications.
- Breast feeding or pregnant females.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00646451
Start Date
June 1 2006
End Date
December 1 2008
Last Update
April 26 2021
Active Locations (1)
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1
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030