Pregabalin (Lyrica) for the Treatment of Essential Tremor

NCT00584376 | Completed Phase 4 DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Essential Tremor

Keywords

Essential tremor; tremor; pregabalin; lyrica

Outcome Measures

Primary Outcomes (1)

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

  61 days

Secondary Outcomes (1)

• Writing tablet recordings of tremor amplitude

  61 days

Study Arms (2)

1

ACTIVE COMPARATOR

Pregabalin

Drug: Pregabalin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pregabalin DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Pfizer: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory Univ. School of Medicine

Atlanta, Georgia, 30329, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Southern Illinois U. School of Medicine

Springfield, Illinois, 62794, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Essential Tremor; Tremor

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Theresa A Zesiewicz, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 18, 2012

Record last verified: 2012-06

Locations

US (8)