Pregabalin in the Treatment of Essential Tremor

NCT00646451 | Completed Early Phase 1 Results

• 1 other identifier: H-19086
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Essential Tremor

Keywords

Essential tremor; Activities of Daily Living (ADL's)

Outcome Measures

Primary Outcomes (1)

• Change in Tremor Rating Scale (TRS) Compared With Baseline.

  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 subscales. The minimum and maximum score for part A is 0-80, part B is 0-36, and part C is 0-28 giving a maximum score of 144. TRS part A rates the severity of resting, postural and action tremor in upper and lower extremities, face, tongue, voice, head and trunk. Part B rates the severity of upper extremity tremor while writing, drawing, and pouring liquid. Part C rates functional disability of tremor while speaking, eating, drinking, maintaining hygiene, dressing, and working. Higher scores represent increased symptom severity or diminished quality of life. .

  baseline to 6 weeks

Secondary Outcomes (1)

• 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)

  baseline to 6 weeks

Study Arms (2)

Pregabalin (Lyrica)

ACTIVE COMPARATOR

Pregabalin (Lyrica) 75 mg bid to a maximum dose of 300 mg bid

Drug: pregabalin (Lyrica)

Placebo

PLACEBO COMPARATOR

Placebo to 4 capsules bid

Drug: placebo

Interventions

pregabalin (Lyrica) DRUG

75 mg bid to 300 mg bid based on per subject tolerability

Also known as: pregabalin

Pregabalin (Lyrica)

placebo DRUG

up to 4 capsules bid as tolerated

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Pfizer: collaborator

Study Sites (1)

PDCMDC 6550 Fannin, Suite 1801

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ferrara JM, Kenney C, Davidson AL, Shinawi L, Kissel AM, Jankovic J. Efficacy and tolerability of pregabalin in essential tremor: a randomized, double-blind, placebo-controlled, crossover trial. J Neurol Sci. 2009 Oct 15;285(1-2):195-7. doi: 10.1016/j.jns.2009.06.044. Epub 2009 Jul 25.

  PMID: 19631949 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This is a investigator initiated trial that was completed in 2008 under 42 CFR 11.22 (b) and does not meet criteria. The study was a pilot and did not lead to registration nor to indication so this level of reporting is not be warranted.

Results Point of Contact

• Title: Dr. Joseph Jankovic
• Organization: Baylor College of Medicine

josephj@bcm.edu

713-798-6556

Study Officials

• Joseph Jankovic, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: March 28, 2008
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 26, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)