Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005515

Trial Description

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Title

Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia

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Trial Acronym

DCP

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URL of the Trial

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Brief Summary in Lay Language

Dystonia is a disorder characterized by excessive involuntary contraction of muscles with
repetitive and patterned movements. The primary focal dystonias are the most common type of
dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic
torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias
(like blepharospasm). The purpose of this study is to create resources to help learn more
about the primary focal dystonias and to develop and validate various dystonia rating
scales.

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Brief Summary in Scientific Language

This collaborative, international effort has two primary goals. The first is to create a
biospecimen repository and associated clinical database to be used as a resource for
dystonia and related disease research. The second goal is to create and validate various
rating scales for focal dystonias to be used during a typical clinical examination. Across
sites, the investigators hope to enroll at least 5,000 adult patients.

Subjects of this study will be asked to complete a neurological exam which will be
videotaped, complete some questionnaires, and donate a blood sample. Subjects with
laryngeal dystonia and voice disorders will also be asked to have a transnasal laryngoscopy
(an exam of the voice box) where the subject has a flexible tube passed through their nose
and into the throat to view the throat and voice box. A study visit will take between 45
minutes and 4 hours depending upon which portions of the study a subject completes. A
subset of subjects will be asked to return annually for a one hour visit.

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Organizational Data

  •   DRKS00005515
  •   2014/01/16
  •   2011/06/02
  •   yes
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Secondary IDs

  •   NCT01373424  (ClinicalTrials.gov)
  •   IRB00046266  (Hyder A. Jinnah, MD, PhD)
  •   1U54NS065701 
  •   RDCRN#6301 
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Health Condition or Problem studied

  •   Dystonia
  •   Voice Disorders
  •   G24 -  Dystonia
  •   R49 -  Voice disturbances
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Observational; time frame: 5 years; There is no primary outcome measure as this is an observational study.

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Canada
  •   Germany
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2011/01/31
  •   5000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Diagnosed with primary dystonia OR

- Diagnosed with voice disorders like muscle tension dysphonia, psychogenic dysphonia,
and vocal fold paresis or paralysis

- To be included in laryngeal dystonia or voice disorder groups, nasolaryngoscopy
(voice box exam) must have been completed to confirm diagnosis

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Exclusion Criteria

- Any evidence of a secondary cause for dystonia

- Less than 2 months since last botulinum toxin injection

Criteria that will keep people from participating in some research activities:

- Any surgical treatment for dystonia

- Significant medical or neurological conditions that preclude completing the
neurological exam

- For those with voice disorders and laryngeal dystonia, significant medical or
neurological conditions that preclude completing a nasolaryngoscopy

- Significant physical or other condition that would confound diagnosis or evaluation,
other than dystonia or tremor

- Being on varying doses of certain medications within the past one month

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hyder A. Jinnah, MD, PhD
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    • National Institute of Neurological Disorders and Stroke (NINDS)
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    • Office of Rare Diseases (ORD)
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    • Allergan
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    • Dystonia Study Group
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    • Emory University
    • H. A. Jinnah, MD, PhD 
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    • Ami R Rosen, MS, CGC 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.