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

Sponsor

University Hospital, Angers (Other)

Overall Status

Unknown status

CT.gov ID

NCT02101957

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: RP103

RP103 capsule, 16 capsules per day

Drug: RP103

Placebo Comparator: placebo

placebo capsule, 16 capsules per day

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Unified Huntington's Disease Rating Scale motor [at 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France	49000

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT02101957

Other Study ID Numbers:

PHRC2004-03bis

First Posted:

Apr 2, 2014

Last Update Posted:

Apr 2, 2014

Last Verified:

Jul 1, 2013

Additional relevant MeSH terms:

Huntington Disease

Study Results

No Results Posted as of Apr 2, 2014