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Clinical Trials/EUCTR2015-004238-85-ES
EUCTR2015-004238-85-ES
Active, not recruiting
Phase 1

Ictal brain SPECT in the premotor stage of Parkinson disease

IDIBAPS0 sites30 target enrollmentDecember 10, 2015
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ConditionsParkinson diseaseMedDRA version: 18.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsCERETEC (TM) Estabilizado

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Parkinson disease
Sponsor
IDIBAPS
Enrollment
30
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IDIBAPS

Eligibility Criteria

Inclusion Criteria

  • •?RBD diagnosis (International classification of Sleep disorders\-2 criteria)
  • •?Idiopatic RBD (non related with neurological diseases nor drug\-treatment related,?)
  • •?Patient can attend to visits
  • •Healthy volunteers:
  • •?Subjects without associated active neurological disease
  • •?Subjects without any relation with investigational team
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •?Diagnosis of mild cognitive impairment or dementia
  • •?Presence of parkinsonian symptom
  • •?Serious medical pathology that can interfere with the performance of tests and clinical data.
  • •?Hypersensitivity to the active substance or any of the excipients
  • •?Subjects with low sodium diet.
  • •?Participation in other clinical trial during the 30 days prior to the study .
  • •?Pregnancy or breastfeeding

Outcomes

Primary Outcomes

Not specified

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