| CTRI Number |
CTRI/2025/11/097282 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of response to levodopa in persons with spinocerebellar ataxia 12 with clinical parkinsonism |
|
Scientific Title of Study
|
Assessment of response to levodopa in persons with spinocerebellar ataxia 12 with clinical parkinsonism - a single arm interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekshmi S H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS New delhi |
| Address |
Department of neurology
All india institute of medical sciences, New Delhi
Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
8075566113 |
| Fax |
|
| Email |
lekshmi.s.h.nair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Achal Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
AIIMS New delhi |
| Address |
Department of neurology
All india institute of medical sciences, New Delhi
Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
9811178784 |
| Fax |
|
| Email |
achalsrivastava@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lekshmi S H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS New delhi |
| Address |
Department of neurology
All india institute of medical sciences, New Delhi
Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
8075566113 |
| Fax |
|
| Email |
lekshmi.s.h.nair@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences , new delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New delhi |
| Address |
Ansari Nagar EAST, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lekshmi s h |
All india institute of medical sciences, New Delhi |
Ataxia clinic , department of neurology , AIIMS delhi
New Delhi
DELHI |
8075566113
lekshmi.s.h.nair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G258||Other specified extrapyramidal andmovement disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Tab Levodopa 125 mg TDS |
Tablet Levodopa 125 mg will be started and will be hiked to the desired dose of 125 mg TDS in 10 day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
•All adult patients with genetically proven diagnosis of SCA 12
•Presence of clinical features of parkinsonism, as assessed and agreed upon by two movement disorder experts, according to the UK Brain Bank criteria for diagnosis of parkinsonism
•Patients on a stable dose of symptomatic medication (e.g. beta-blockers for tremor) for three months prior to enrolment
|
|
| ExclusionCriteria |
| Details |
Participants meeting any one of the following will be excluded .
1.Patients with history of use of any antipsychotic medications, or drugs that can cause drug-induced parkinsonism like D2-blockers etc. in the past
2.Pregnant and lactating females
3.Chronic diseases like Chronic Kidney Disease, Chronic Liver Disease
4.Known allergies or intolerance to levodopa therapy
5.Patients already on levodopa therapy at the time of recruitment
6.Patients who are unwilling to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in MDS UPDRS part III score from baseline at three months of levodopa therapy among patients with genetically proven Spino cerebellar ataxia 12 with clinical parkinsonism. |
baseline and at three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Striatal outcomes using DAT scan in persons with SCA 12 |
at baseline |
| To assess improvement from baseline in Quality of life using SF 36 , Tremors(tetras score), Non motor symptoms score |
at baseline and 3 months |
| Correlation between CAG trinucleotide repeats and Levodopa response |
at baseline and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SCA 12 Iis a rare autosomal dominant inherited ataxia due to expanded cag trinucleotide repaets in PPP2R2B gene located on chromosome 5q31. It is prevalent among the agarwal community. Currently there is no definite cure for SCA 12. In the absence of definitive curative therapy, symptom amelioration is of utmost importance. Parkinsonian features including rigidity bradykinesia, and rest tremor may be highly disabling and thus addressing them efficiently is likely to positively impact quality of life. Response to levodopa in persons with SCA 12 WITH PARKINSONISM HAS NEVER BEEN SSTUDIED. iN ADDITION dat IMAGING FINDINGS IN sca 12 are not delineated in current literature. Hence we aim to assess response to levodopa therapy in persons with SCA 12 with clinical parkinsonism to assess impact of levodopa therapy on quality of life , non motor symptoms, tremors with levodopa treatment and inform DAT findings. |