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Completed

NCT Number: NCT00584376

Pregabalin (Lyrica) for the Treatment of Essential Tremor

This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients with essential tremor diagnosed by a movement disorder specialist.
  • Age 18 years to 80 years.
  • Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
  • Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
  • Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
  • Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year).
  • Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion criteria

  • Any illness that in the investigator's opinion preclude participation in this study.
  • Pregnancy or lactation.
  • Concurrent participation in another clinical study.
  • Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
  • Legal incapacity or limited legal capacity.
  • Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.
  • Presence of severe daytime sleepiness.
  • Abnormal creatine kinase and/or platelet count in the past year.
  • Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
  • Previous lack of response to other ET therapies (propranolol AND primidone).
  • Patients who have had deep brain stimulation (DBS).
  • Concomitant treatment with gabapentin.

Treatment and study plan

Pregabalin

Drug

Gradually titrated dose ranging from 75mg po bid to 225mg po bid.

Placebo

Drug

Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.

Primary outcomes

  1. Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score

    Time frame: 61 days

Secondary outcomes

  1. Writing tablet recordings of tremor amplitude

    Time frame: 61 days

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 2, 2008
Registry last updated
Jun 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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