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Trial record 21 of 32 for:    CYSTEAMINE

Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)

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ClinicalTrials.gov Identifier: NCT02101957
Recruitment Status : Unknown
Verified July 2013 by University Hospital, Angers.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study group 1996).

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: RP103 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2010
Estimated Primary Completion Date : July 2015


Arm Intervention/treatment
Experimental: RP103
RP103 capsule, 16 capsules per day
Drug: RP103
Placebo Comparator: placebo
placebo capsule, 16 capsules per day
Drug: Placebo



Primary Outcome Measures :
  1. Unified Huntington's Disease Rating Scale motor [ Time Frame: at 18 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically disease-registered for at least one year, leading to consult (abnormal movements, neuropsychiatric disorders, neuropsychological impairment).
  • Unified Huntington's Disease Rating Scale motor ≥ 5
  • Total Functional Capacity > 10 (≥ 11)
  • Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide expansion (CAG)
  • Age between 18 and 65
  • Voluntarily Patient Consent
  • Patients willing and able to take oral medications, and comply with the specific procedures of the study

Exclusion Criteria:

  • Severe cognitive impairment or neuropsychiatric troubles.
  • No drug compliance to previous treatment.
  • Patients with contra indication to the realization of imaging studies (including claustrophobia ) .
  • Patients who have not given their written and informed consent signed .
  • No national health insurance affiliation
  • Private patients of their liberty by judicial or administrative decision, or patients under supervision.
  • Pregnant women ( pregnancy test will be carried out systematically for women at risk) or lactating .
  • Women who could become pregnant during the study period and with no contraception.
  • Patients who have developed hypersensitivity to cysteamine or penicillamine ( against indication of cysteamine ) .
  • Brain Damage intercurrent MRI. Brain morphological abnormalities , other than those characteristic of the disease .
  • Disease - associated with neurological repercussions.
  • Affection - visceral serious , scalable , involving life-threatening.
  • Mental - disorder may disrupt accession to the Protocol , including a history of spontaneous and / or drug-induced hallucinations history of severe depression that required repeated hospitalizations , history of repeated suicide attempts .
  • Participation in progress, or interrupted for less than three months, a therapeutic protocol of Huntington's disease .
  • Patients with a history of surgical interventions to improve the symptoms of Huntington 's disease such as graft neuron, deep brain stimulation, infusion of neurotrophic agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101957


Locations
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France
CHU Angers
Angers, France, 49000
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02101957     History of Changes
Other Study ID Numbers: PHRC2004-03bis
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: July 2013
Additional relevant MeSH terms:
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Cysteamine
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cystine Depleting Agents
Molecular Mechanisms of Pharmacological Action