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Pregabalin in the Treatment of Essential Tremor

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusTamamlandı
Sponsorlar
Baylor College of Medicine
Əməkdaşlar
Pfizer

Açar sözlər

Mücərrəd

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?

Tarixlər

Son Doğrulandı: 10/31/2015
İlk təqdim: 12/27/2007
Təxmini qeydiyyat təqdim edildi: 03/25/2008
İlk Göndərmə: 03/27/2008
Son Yeniləmə Göndərildi: 11/03/2015
Son Yeniləmə Göndərildi: 11/05/2015
Həqiqi Təhsilin Başlama Tarixi: 05/31/2006
Təxmini İlkin Tamamlanma Tarixi: 11/30/2008
Təxmini İşin Tamamlanma Tarixi: 11/30/2008

Vəziyyət və ya xəstəlik

Essential Tremor

Müdaxilə / müalicə

Drug: 1

Drug: 2

Faza

Faza 4

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: 1
Pregabalin 75 mg bid to a maximum dose of 300 mg bid
Drug: 1
75 mg bid to 300 mg bid based on per subject tolerability
Placebo Comparator: 2
Placebo to 4 capsules bid
Drug: 2
up to 4 capsules bid as tolerated

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

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.

Nəticə

İlkin nəticə tədbirləri

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. [baseline to completion]

İkincili Nəticə Tədbirləri

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

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