Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT03252535
• Date of registration: 15/08/2017
• Prospective Registration: Yes
• Primary sponsor: Azidus Brasil
• Public title: Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease ADORE-DH
• Scientific title: Dose-Response Evaluation of the Investigational Product Cellavita HD After Intravenous Administration in Patients With Huntington's Disease
• Date of first enrolment: January 15, 2018
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03252535
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Brazil

Contacts

• Name: Joyce Macedo da Silva, MD
• Affiliation: Azidus Brasil Scientific Research and Development Ltda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provide a written, signed and dated Informed Consent Form;

2. Male and female subjects aged = 21 and = 65 years;

3. Have a confirmatory diagnosis report (PCR) of Huntington's disease with a number of
CAG repeats in chromosome 4 higher than or equal to 40, and lower than or equal to 50
(if the subject did not perform the exam and/or if he/she does not have an available
result for this exam, a new exam must be performed);

4. A score of 5 points or higher for the motor evaluation of the UHDRS scale (Unified
Huntington's Disease Rating Scale) at enrollment;

5. Score of 8 to 11 points for the functional capacity of the UHDRS scale at enrollment.

Exclusion Criteria:

1. Subject who participated in clinical trials protocols within the last twelve (12)
months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless, at the
investigator's opinion, the subject would have a direct benefit from it;

2. Diagnosis of juvenile Huntington's disease;

3. Diagnosis of epilepsy;

4. Diagnosis of major cognitive disorder;

5. Active decompensated psychiatric illness;

6. Current or prior history of neoplasm;

7. Current history of gastrointestinal, hepatic, renal, endocrine, pulmonary,
hematological, immunological, metabolic pathology or severe uncontrolled
cardiovascular diseases;

8. Diagnosis of any active infection, whether viral, bacterial, fungal or caused by
another pathogen;

9. Subject with contraindication to the exams performed in this study, for example, with
pacemaker or surgical clip; Alcohol and drugs abuse (previously diagnosed according to
the Diagnostic and Statistical Manual of Mental Disorders - DSM V criteria);

10. Use of illegal drugs;

11. Tabagism;

12. Smoker or quit smoking for less than 6 months;

13. Positive result in one of the serum tests: HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II,
HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab) and FTA-ABS (Treponema pallidum);

14. History of drug allergy, including to contrast agents used in imaging tests or
bovine-derived products;

15. Using or expects to use immunosuppressant drugs or forbidden drugs (item 5.3) during
the first three months after the first administration of the investigational product;

16. Any clinical change that the investigator considers a risk to subject's enrollment in
the study.



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington Disease

Intervention(s)

Biological: Cellavita HD lower dose

Biological: Cellavita HD higher dose

Other: Placebo

Primary Outcome(s)

Effective Dose [Time Frame: monthly for fourteen months]

Secondary Outcome(s)

CNS assessment [Time Frame: baseline and one year later]

Clinical Interview Based impression of Severity (CIBIS) [Time Frame: monthly for fourteen months]

Risk of suicidal ideation [Time Frame: monthly for fourteen months]

Clinical neurological worsening over the treatment [Time Frame: monthly for fourteen months]

BMI assessment [Time Frame: monthly for fourteen months]

Secondary ID(s)

52375916.1.0000.5412

ADORE-DH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cellavita Pesquisa Científica Ltda