Pregabalin (Lyrica) for the Treatment of Essential Tremor

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584376
• Other study ID #: 2
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2007
• Last updated: June 15, 2012
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: June 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Outpatients with essential tremor diagnosed by a movement disorder specialist.

2. Age 18 years to 80 years.

3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.

4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.

5. Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).

6. 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).

7. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.

2. Pregnancy or lactation.

3. Concurrent participation in another clinical study.

4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).

5. Legal incapacity or limited legal capacity.

6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.

7. Presence of severe daytime sleepiness.

8. Abnormal creatine kinase and/or platelet count in the past year.

9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.

10. Previous lack of response to other ET therapies (propranolol AND primidone).

11. Patients who have had deep brain stimulation (DBS).

12. Concomitant treatment with gabapentin.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Drug:
• Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
• Placebo
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.

Locations

Country	Name	City	State
United States	Emory Univ. School of Medicine	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Vanderbilt	Nashville	Tennessee
United States	Southern Illinois U. School of Medicine	Springfield	Illinois
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score		61 days	No
Secondary	Writing tablet recordings of tremor amplitude		61 days	No