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Pregabalin in the Treatment of Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646451
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : November 6, 2015
Information provided by (Responsible Party):
Joseph Jankovic, Baylor College of Medicine

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 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 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?

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: pregabalin Drug: placebo capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 17 Week, Investigator-initiated, Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Trial of Pregabalin in Essential Tremor
Study Start Date : June 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: 1
Pregabalin 75 mg bid to a maximum dose of 300 mg bid
Drug: pregabalin
75 mg bid to 300 mg bid based on per subject tolerability
Other Name: Lyrica

Placebo Comparator: 2
Placebo to 4 capsules bid
Drug: placebo capsules
up to 4 capsules bid as tolerated

Primary Outcome Measures :
  1. Change from baseline in the overall TRS score obtained at the final evaluation (end of study). The overall TRS score will be derived from the three TRS subcecals giving a maximum score of 84 which will be converted to a 100 point scale. [ Time Frame: baseline to completion ]

Secondary Outcome Measures :
  1. Nonparametric tests will be employed and exact p (2 tailed) values computed for the categorical dependent variables. [ Time Frame: baseline to completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be between the ages of 18 and 80 inclusive.
  2. 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.
  3. Subjects with a history of seizures are eligible.
  4. Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
  5. 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.
  6. Subjects must be accessible by telephone.
  7. 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
  8. Prior to participation in this study, each subject must sign an informed consent.

Exclusion Criteria:

  1. Patients do not meet TRIG criteria for probable ET.
  2. Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
  3. Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement.
  4. Subjects who have exhibited any psychotic symptomatology.
  5. Subjects who have known renal deficiencies.
  6. Subjects who have been intolerant of pregabalin in the past
  7. Prior surgical treatment for tremor.
  8. Patients currently taking more than a single drug for ET.
  9. Patients taking anti-seizure medications.
  10. Breast feeding or pregnant females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646451

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United States, Texas
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: Joseph Jankovic, Principal Investigator, Baylor College of Medicine Identifier: NCT00646451     History of Changes
Other Study ID Numbers: H-19086
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Keywords provided by Joseph Jankovic, Baylor College of Medicine:
Essential tremor
Activities of Daily Living (ADL's)
Additional relevant MeSH terms:
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Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs