Early Phase 1 N=20 Randomized Quadruple-blind Treatment

Pregabalin in the Treatment of Essential Tremor

Essential Tremor

Bottom Line

View on ClinicalTrials.gov: NCT00646451 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in Tremor Rating Scale (TRS) Compared With Baseline. — 2.4; -0.2; 6.7; 3.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: pregabalin (Lyrica) (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Tremor Rating Scale (TRS) Compared With Baseline.	2.4; -0.2; 6.7; 3.6; 4.5; -1.5	—
SECONDARY Secondary Outcome Measures Quality of Life in Essential Tremor (QUEST), Hamilton Anxiety Scale (HAM-A), Hotel Dieu-16 a Sleep Hygiene Questionnaire(HD-16), and Clinical Clobal Impression-Change Scale (CGI-C)	8.0; -9.7; 1.1; 4.1; 32.2; -38.6	0.162

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 use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both of these nerve pain states. Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a shirt). It occurs most often in the hands and head and also may affect the arms, voice box (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control movement. It usually does not result in serious complications. ET affects approximately 5 million people in the United States. Incidence is highest in people over the age of 60. ET usually develops gradually during middle age or later in life. Symptoms may remain mild or become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen the disorder. Severe tremor may cause difficulty doing activities of daily living, such as: * Brushing hair and teeth * Holding a glass without spilling * Performing self-care (e.g., getting dressed, shaving, putting on makeup) * Using eating utensils * Writing and drawing The purpose of this pilot/feasibility study is to examine the tolerability and efficacy of Pregabalin in patients with ET. In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00646451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.