Clinical TrialID 3767
L-Serine Supplementation in Hereditary Sensory Neuropathy Type 1
NCT01733407
Hereditary Sensory and Autonomic Neuropathy Type I
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3767
- Evidence Id
- 3767
- Core Evidence Id
- 3767
- Source Clinical Trial Id
- 3741
- Herb2 Clinical Trial Id
- HBCT003741
- Nct Id
- NCT01733407
- Title
- L-Serine Supplementation in Hereditary Sensory Neuropathy Type 1
- Status
- Completed
- Phase
- Phase 1|Phase 2
- Study Result
- Yes
- Study Condition
- Hereditary Sensory and Autonomic Neuropathy Type I
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: L-serine|DRUG: placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 18
- Outcome Measure
- Charcot Marie Tooth Neuropathy Score, The Charcot Marie Tooth Neuropathy Score (CMTNS) is a 0 to 36 point composite scoring assessment that is used to measure disease severity in Charcot Marie Tooth Neuropathy and other sensory and motor neuropathies. The CMTNS is composed of 9 items that evaluate functions related to disease progression. These 9 parameters include reviewing sensory symptoms, motor symptoms (arms and legs), pinprick sensibility, vibration, leg strength, arm strength, and nerve conduction tests. Each item is scored from 0 to 4, with the lower scores representing less severe symptoms and higher scores representing more severe symptoms.The 9 individual item scores are then totaled to provide a global measure of disease severity. For example the lowest possible total score is 0 which represents an asymptomatic individual and the highest score possible is a 36 which represents an individual with severe disease progression. There are sub scores that can be assessed but sub scores were not utilized in this study, 48 Weeks
- Sponsor Collaborator
- Massachusetts General Hospital
- Funded By
- OTHER
- Location
- Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|UMass Medical Center, Worcester, Massachusetts, 01605, United States
- Other Id
- FD-R-04127-01
- Start Date
- 2013-09
- Primary Completion Date
- 2016-05
- Completion Date
- 2017-07
- First Posted
- 2012-11-27
- Results First Posted
- 2018-09-12
- Last Update Posted
- 2018-09-12
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01733407
- Title Cn
- Title En
- L-Serine Supplementation in Hereditary Sensory Neuropathy Type 1
- Bilingual Status
- semi_complete