Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Essential Tremor Clinical Trial

Official title:

Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01441284
• Other study ID #: AOK_KA_2011_pramipexole
• Secondary ID: 34039/KA-OTKA/11
• Status: Withdrawn
• Phase: Phase 3
• First received: September 21, 2011
• Last updated: May 4, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

Description:

Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.

Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, >50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.

In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.

The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.

• Tremor has to be severe enough to produce disability.

• Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs

Exclusion Criteria:

• Exclusion criteria are established in accordance to the guidelines of Elble et al3.

• Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).

• Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)

• Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)

• Presence or suspicion of psychogenic tremor

• Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)

• Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).

• Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).

• Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)

• Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Drug:
• pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
• placebo
placebo

Locations

Country	Name	City	State
Hungary	Kaposi Mór County Hospital	Kaposvár	Somogy Megye
Hungary	Department of Neurology, University of Pécs	Pécs	Baranya Megye

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Kovács N, Pál E, Késmárky I, Komoly S, Nagy F, Herceg M. Pramipexole for treating essential tremor. Eur J Neurol 2011;18(Suppl 2):482.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in tremor severity	Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale	10 weeks of treatment
Secondary	Improvement in quality of life	Improvement in quality of life assessed by EQ-5D score	10 weeks of treatment
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		10 weeks of treatment