Clinical TrialID 6611
Deoxynucleosides Pyrimidines as Treatment for Mitochondrial Depletion Syndrome
NCT04802707
Mitochondrial Diseases|Mitochondrial Encephalomyopathy|Mitochondrial Encephalopathy|Mitochondrial DNA Depletion|Mitochondrial Metabolism Disorders
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6611
- Evidence Id
- 6611
- Core Evidence Id
- 6611
- Source Clinical Trial Id
- 6598
- Herb2 Clinical Trial Id
- HBCT006598
- Nct Id
- NCT04802707
- Title
- Deoxynucleosides Pyrimidines as Treatment for Mitochondrial Depletion Syndrome
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Mitochondrial Diseases|Mitochondrial Encephalomyopathy|Mitochondrial Encephalopathy|Mitochondrial DNA Depletion|Mitochondrial Metabolism Disorders
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- COMBINATION_PRODUCT: deoxycytidine and deoxythymidine
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 50
- Outcome Measure
- Rate of Responder versus Non-Responder Status with investigational product, "Responder" defined as having ≥ 2 of (1) electroencephalography EEG improvement, (2) decreased seizure frequency, (3) cognitive improvement, (4) caregiver impression of improvement, (5) clinical improvement, (6) Normal Organics and Metabolism functions Description of the primary variable(s) The primary efficacy endpoint is the composite cluster of the first occurrence, over the duration of study, of Mitochondria Depletion Syndrome., 104 weeks
- Sponsor Collaborator
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Funded By
- OTHER
- Location
- Research InstituMcGill University Health Centre - Children Hospital of Montreal, Montréal, Quebec, H4A 3J1, Canada
- Other Id
- 2021-7654 dC-dT-MDS
- Start Date
- 2021-10-18
- Primary Completion Date
- 2025-12-31
- Completion Date
- 2026-06-30
- First Posted
- 2021-03-17
- Results First Posted
- Last Update Posted
- 2024-03-13
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04802707
- Title Cn
- Title En
- Deoxynucleosides Pyrimidines as Treatment for Mitochondrial Depletion Syndrome
- Bilingual Status
- semi_complete